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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. This approval is based on results from the Phase 3 KEYNOTE-564 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS), reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) after a median follow-up of 23.9 months compared to placebo, in patients at increased risk of recurrence (defined in the clinical trial protocol as intermediate-high or high risk following nephrectomy and those with resected advanced disease).

KEYTRUDA addresses a critical unmet need for treatment options that help patients reduce their risk of cancer returning following surgery, said Dr. Thomas Powles, professor of Genitourinary Oncology and director of Barts Cancer Centre at St. Bartholomews Hospital. The European Commissions approval of KEYTRUDA brings certain patients with renal cell carcinoma a long-awaited therapy that has demonstrated a statistically significant reduction in the risk of disease recurrence or death by almost a third.

KEYTRUDA is the first adjuvant therapy approved for certain patients with renal cell carcinoma in Europe, providing the option of immunotherapy earlier in the course of their treatment, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. This approval demonstrates our progress in bringing KEYTRUDA to patients with earlier stages of cancer, with the goal of helping more patients around the globe prevent disease recurrence.

This approval allows marketing of KEYTRUDA monotherapy in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland.

Merck has a broad clinical development program exploring KEYTRUDA, as monotherapy or in combination, as well as several other investigational and approved medicines across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease.

Data Supporting the European Approval

The approval was based on data from KEYNOTE-564 (NCT03142334), a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 994 patients with increased risk of recurrence of RCC defined as intermediate-high or high risk, or M1 with no evidence of disease (NED). Patients must have undergone a partial or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion[s] in M1 NED participants) with negative surgical margins for at least four weeks prior to the time of screening. Patients with active autoimmune disease or a medical condition that required immunosuppression were excluded from the study. The primary efficacy outcome measure was investigator-assessed DFS. The secondary efficacy outcome measure was overall survival (OS). Patients with RCC with clear cell component were randomized (1:1) to receive KEYTRUDA 200 mg administered intravenously every three weeks (n=496) or placebo (n=498) for up to one year until disease recurrence or unacceptable toxicity.

At a pre-specified interim analysis with a median follow-up time of 23.9 months, KEYTRUDA demonstrated a statistically significant improvement in DFS, reducing the risk of disease recurrence or death by 32% (HR=0.68 [95% CI, 0.53-0.87]; p=0.0010) compared with placebo in patients with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Updated efficacy results with a median follow-up time of 29.7 months demonstrated KEYTRUDA reduced the risk of disease recurrence or death by 37% (HR=0.63 [95% CI, 0.50-0.80]; p<0.0001) compared with placebo. Median DFS has not been reached for either group. The trial will continue to assess OS as a secondary outcome measure.

The safety of KEYTRUDA as monotherapy has been evaluated in 7,148 patients with advanced melanoma, resected stage III melanoma (adjuvant therapy), non-small cell lung cancer, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, colorectal cancer, endometrial, gastric, small intestine, biliary, pancreatic cancer or adjuvant therapy of RCC across four doses (2 mg/kg bodyweight [bw] every three weeks, 200 mg every three weeks, or 10 mg/kg bw every two or three weeks) in clinical studies. In this patient population, the most frequent adverse reactions with KEYTRUDA were fatigue (31%), diarrhea (22%) and nausea (21%). The majority of adverse reactions reported for KEYTRUDA monotherapy were of Grades 1 or 2 severity. The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions. The incidences of immune-related adverse reactions were 36.1% for all Grades and 8.9% for Grades 3-5 for KEYTRUDA monotherapy in the adjuvant setting (n=1,480) and 24.2% for all Grades and 6.4% for Grades 3-5 in the metastatic setting (n=5,375). No new immune-related adverse reactions were identified in the adjuvant setting.

About Renal Cell Carcinoma

Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancer diagnoses are RCCs. Renal cell carcinoma is about twice as common in men than in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Worldwide, it is estimated there were more than 431,000 new cases of kidney cancer diagnosed and more than 179,000 deaths from the disease in 2020. In Europe, it is estimated there were more than 138,000 new cases of kidney cancer diagnosed and more than 54,000 deaths from the disease in 2020.

About Mercks Early-Stage Cancer Clinical Program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,700 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.

KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or GEJ (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Cancer

KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of antiPD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

First-line treatment of advanced RCC in combination therapy with axitinib (KEYNOTE-426)

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT 3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT 3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT 3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with antiPD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other antiPD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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European Commission Approves Merck's KEYTRUDA (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following...

This Rapid Risk Assessment extends the assessment of the further emergence and potential impact of Omicron in the context of ongoing transmission of the Delta variant that was published on 15 December 2021, to include new epidemiological data on the spread of Omicron, new data on vaccine uptake, updated forecasts, and the latest evidence on Omicron transmissibility, severity, immune escape, vaccine effectiveness, post-COVID-19 condition, and non-pharmaceutical interventions.

The SARS-CoV-2 Omicron variant of concern (VOC) is rapidly replacing SARS-CoV-2 Delta in most European Union/European Economic Area (EU/EEA) countries, and is broadly following a west-to-east progression. As pointed out by earlier in vitro and in vivo studies, Omicron can to a degree evade the protective effects of antibodies elicited by vaccination or natural infection according to factors such as number of vaccinations or time since last vaccination, thus leaving large portions of the EU/EEA population susceptible to infection. This has resulted in sharp increases in the number of COVID-19 cases, reaching an unprecedented intensity of community transmission across the region.

In comparison with earlier circulating variants, Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or ICU admission. Hence, although the current overall 14-day notification rate in the EU/EEA is 2 621 cases per 100 000 population, which is three times higher than the highest peak observed during the pandemic to date, hospitalisation rates and mortality are below the levels observed in earlier pandemic waves. However, the number of cases among older people has been increasing more recently in several EU/EEA countries, and this could result in a delayed increase of severe cases and deaths. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that a significant role in preventing severe clinical outcomes from Omicron infection is played by vaccination, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. Since vaccination uptake is variable across EU/EEA countries (country range: 28.482.9%, average 69.4%) and since the uptake of booster doses is still at suboptimal levels in the majority of EU/EEA countries (80% of EU/EEA countries with booster uptake among adults below 60% as of week 2-2022), the expected impact of Omicron will vary, but countries with lower vaccine uptake are expected to experience the highest disease burden. Furthermore, given the very high levels of community transmission observed regardless of overall vaccine uptake, leading to many people being sick at the same time, countries with very high vaccine uptake will also likely undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole (mainly through absence from work and education).

Mathematical modelling results demonstrate that there is a substantial proportion of the population that remains vulnerable to severe outcomes across all EU/EEA countries, especially in those with lower vaccination coverage. Static projections show hospitalisations and mortality are expected to have a proportionally greater impact among people 60 years and older but will also impact people younger than 60 years. In response to the high incidence of Omicron, protection against the risk of high hospitalisation burden can be accomplished by increasing overall vaccination uptake, including rapidly administering booster doses, especially in the older and at-risk population, will protect against the risk of high hospitalisation burden. Furthermore, the vaccines and boosters provide additional longer-term benefits for individuals and society (e.g. preventing absence from work or education and post-acute COVID-19 syndrome).

There are no data so far on the incidence of prolonged symptoms after COVID-19 due to Omicron, nor on whether this differs from the incidence of post-COVID syndrome brought about by previously circulating variants of SARS-CoV-2. It is plausible that the large number of cases of Omicron infection may be followed by a high incidence of post-COVID-19 condition, with a proportionally higher incidence among people who are unvaccinated.

While we expect to be moving towards a more sustainable situation with COVID-19 circulating at manageable levels, we currently remain in a public health emergency pandemic situation, and it is important to note that even in a post-pandemic phase SARS-CoV-2 could still periodically cause high levels of strain on healthcare systems and lead to large outbreaks. Thus, moving forward, multi-layered surveillance, preparedness, and response strategies for addressing COVID-19 will be essential.

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Assessment of the further spread and potential impact of the SARS-CoV-2 Omicron variant of concern in the EU/EEA, 19th update - EU News

It feels like a scene from the Cold War.

An unpredictable Russian president amassing thousands of troops on the border of a neighboring country, Ukraine. The threat of invasion. A possible bloody conflagration between East and West.

But what may seem like a perilous episode from a bygone era is now front and center in global diplomacy as the United States jockeys to deter a Russian incursion into Ukraine.

The situation intensified over the weekend as it emerged that President Biden was considering deploying several thousand U.S. troops, as well as warships and aircraft, to NATO allies in the Baltics and Eastern Europe. The move appeared to signal a shift from the Biden administration which has taken pains to avoid provoking Russia.

But with President Vladimir V. Putin of Russia ramping up his threats and talks between American and Russian officials failing to defuse the crisis, the administration appeared to be changing tack.

Russia has mobilized about 100,000 troops near its border with Ukraine. The United States has disclosed intelligence showing that Russia has a war plan envisioning an invasion force of 175,000 troops that Ukraines military, despite U.S.-provided equipment and training, would have little ability to stop.

Mr. Biden has said that an invasion would be the most consequential thing thats happened in the world in terms of war and peace since World War II. Current intelligence assessments described by White House officials conclude that Mr. Putin has not made a decision about whether to invade. And so far, none of the military options being considered include deploying additional American troops to Ukraine itself.

A potential military flare-up threatens to destabilize the already volatile post-Soviet region, buffeted by the popular revolt this month in Kazakhstan. It would also have serious consequences for the security structure that has governed Europe since the collapse of the Soviet Union three decades ago.

Russia has made a list of far-reaching demands, including that NATO pledge to halt further eastward expansion and agree not to admit Ukraine as a member. But the United States has called those positions unacceptable. Russian officials have repeatedly insisted that Moscow has no plans to invade Ukraine and that the massive troop buildup is just for exercises.

Essentially, Mr. Putin is seeking to redraw the post-Cold War boundaries of Europe, establishing a broad, Russian-dominated security zone and drawing Ukraine back into Moscows orbit by force, if necessary.

In the event of an invasion, the United States and its allies have threatened to impose a series of sanctions that would go far beyond those imposed in 2014, after the Russian annexation of Crimea. Mr. Putin has warned that imposing new sanctions could lead to a complete rupture in relations with Washington.

Tensions between Ukraine and Russia have been simmering since 2014. Thats when Ukraine ousted its pro-Russian president and the Russian military crossed into Ukrainian territory, annexing Crimea and fomenting a rebellion by separatists in eastern Ukraine. A tenuous cease-fire was reached in 2015, but peace has been elusive amid a grinding war that has killed more than 13,000 soldiers and civilians.

The Kremlins position toward its neighbor has been hardening, as Mr. Putin has grown more insistent that Ukraine is fundamentally a part of Russia, culturally and historically. Concerns were raised in late October, when Ukraine used an armed drone to attack a howitzer operated by Russian-backed separatists in eastern Ukraine. Russia called the strike a destabilizing act that violated the cease-fire agreement.

Now 69 years old and edging toward the twilight of his political career, Mr. Putin is determined to burnish his legacy and to correct what he has long viewed as a catastrophe of the 20th century: the disintegration of the former Soviet Union.

Asserting Moscows power over Ukraine, a country of 44 million people that was previously part of the Soviet bloc and shares a 1,200-mile border with Russia, is part of his aim of restoring what he views as Russias rightful place among the worlds great powers, along with the United States and China.

Mr. Putin has increasingly portrayed NATOs eastward expansion as an existential threat to his country, and insists that Moscows military buildup is a reaction to Ukraines intensifying ties with the alliance. He appears intent on winding back the clock 30 years, to just before the collapse of the Soviet Union.

The timing of Russias troop mobilization is perhaps no coincidence. Mr. Putin is seeking to energize nationalist support at home amid a raging pandemic and a stumbling economy. Last year, opposition groups held some of the largest anti-Putin protests in years.

But while some analysts have portrayed Mr. Putin as a wily chess player adroitly manipulating the West, his latest gambit could backfire. NATO could reinforce its military presence in member countries bordering Russia, like the Baltics. And an invasion would invite punishing sanctions that could diminish his support in a country weary of foreign adventures.

In Ukraine, meanwhile, Moscows aggressive posture has further inflamed nationalist passions, with citizen militias preparing for a drawn-out guerrilla campaign in the event of a Russian occupation. And if Mr. Putins aim is to reassert Russias sphere of influence, invading Ukraine would further destabilize the post-Soviet region, where Russian troops are helping restore order in Kazakhstan and Belarus is still smoldering after an uprising in 2020.

In early December, Mr. Biden made clear that his administration was not considering sending troops to Ukraine, since, among other reasons, Ukraine is not a member of the NATO alliance and does not come under its commitment to collective defense.

Instead, Mr. Biden has said that he would reinforce the American military presence in NATO countries that border Russia. And, referring to Mr. Putin, he has promised that there would be economic consequences like none hes ever seen.

The United States and NATO gave formal responses on Wednesday to Russias demands that NATO pull back forces from Eastern Europe and bar Ukraine from ever joining the alliance. While the United States has previously made clear that those demands are nonstarters, Secretary of State Antony J. Blinken said the U.S. written response set out a diplomatic path for Russia out of the crisis and outlined measures to increase confidence regarding military exercises and maneuvers in Europe, as well as nuclear arms control in Europe.

Ominous warnings. Russia called the strike a destabilizing act that violated the cease-fire agreement, raising fears of a new intervention in Ukraine that could draw the United States and Europe into a new phase of the conflict.

The Kremlins position. President Vladimir V. Putin of Russia, who has increasingly portrayed NATOs eastward expansion as an existential threat to his country, said that Moscows military buildupwas a response to Ukraines deepening partnership with the alliance.

The Biden administration has already made such proposals, so it is unclear whether the U.S. response will make a difference.

Mr. Biden is considering several options that would shift American military assets much closer to Mr. Putins doorstep. The options include sending 1,000 to 5,000 troops to Eastern European countries, with the potential to increase that number tenfold if the situation deteriorates.

Biden officials have also recently warned that the United States could throw its weight behind a Ukrainian insurgency should Mr. Putin invade Ukraine.

U.S. officials have hinted that Washington could be turning to its China playbook potentially instituting sanctions that could deprive Russians of their beloved next-generation phones, laptops and other gadgets, and the military from advanced equipment. There is also the option of cutting Russia off from the international banking system, though analysts have said that is unlikely.

An intensifying conflict in Ukraine would test the resolve of the Biden administration, which has been working to restore confidence in Americas global leadership following the recent messy withdrawal from Afghanistan and its retrenchment from foreign engagements under President Donald J. Trump.

How the United States handles Russia and Ukraine will affect its ongoing efforts at rebuilding frayed ties with NATO allies after the Trump presidency, during which Mr. Trump declared the alliance obsolete.

An escalating crisis in Ukraine also threatens to upend recent efforts by the United States and NATO to shift the alliances attention to the security challenge posed by China.

At stake for Europe is whether it can allow Mr. Putin to upend the security structure that has helped keep the peace on the continent since World War II. And with Europeans divided over how to respond to various forms of Russian aggression, the conflict has also laid bare the weakness of the European Union and its failure as a foreign policy force in international relations.

With the departure of Chancellor Angela Merkel, who grew up in the east, speaks fluent Russian, and had developed a good working relationship with Mr. Putin, Europe lost an invaluable interlocutor with Moscow.

Europe has important trade ties with Russia, and would stand to lose far more than the U.S. from sanctions imposed after a Russian invasion of Ukraine. It is also dependent on Russian gas supplies, a weakness that Mr. Putin has exploited in past disputes.

Steven Erlanger in Brussels contributed reporting.

Read more:
What Does Russia Want in Ukraine? The Tensions Explained - The New York Times

Mike Parker, a lifelong fighter for social justice, died at the age of eighty-one on January 15, 2022. He was not broadly known even in left circles, as he stayed out of the limelight throughout his life to instead promote others. But his contributions to a wide range of social movements, the labor movement, and socialist thinking were enormous.

Mikes activism began in college in the antiwar movement in the late 1950s and early 1960s, and continued until his death as a member of the Steering Committee of the Richmond Progressive Alliance. Throughout his life, he was a leader of various socialist organizations. He was a rank-and-file autoworker and an early supporter of Labor Notes. Mike was committed, kind, brilliant, and generous with his time and ideas. Countless activists considered him a mentor; he was respected and loved by many. His death is an incalculable loss to the cause of winning a more just and democratic world.

Mikes parents had been members of the Socialist Party, and growing up, he viewed himself as a socialist in the way children identify with the political party of their parents. In the antiwar movement, he came to understand that socialism required a fundamental restructuring of society. He joined the Young Peoples Socialist League (YPSL) in 1959.

Mike first became an activist in the antiwar movement, years before the Vietnam War, and was a national leader of the SPU (Student Peace Union), the largest student organization in the country in the early 1960s, headquartered in Chicago. Mike ran the SPU office, often sleeping there. In the small organizations campaigns, especially around issues of nuclear weapons, Mike did it all, running the mimeograph machine when needed and giving political guidance to the many who called. Kim Moody, a writer on labor issues, founder of Labor Notes, and socialist for many decades, recalls meeting Mike for the first time at an SPU convention in 1960: Mike was impressive even then.

In the SPU, Mike began questioning the role of the US arms industry. In an interview about those early years with Democratic Socialists of America (DSA) activist Jeremy Gong, Mike explained, You realize that youre up against these arms contractors and have this crude understanding why is the US basically building for annihilation of the human race? And why are we spending all of this [money] on that? He concluded that the arms industry needed war to thrive under capitalism.

Even in these early days, Mike was always drawing activists around him. One of them was Senator Bernie Sanders, who released a statement upon Mikes passing:

I knew Mike Parker when I was a student at the University of Chicago in the early 1960s. Mike was a brilliant advocate for workers and unions then, and he remained so for the rest of his life. Mike fought tirelessly for human solidarity and a more just and humane world. His lifes work and dedication should serve as an example for us all.

From the beginning, Mike was always involved in both broad social movements and socialist groups. He was deeply affected by the Soviet Unions crushing of the Hungarian Revolution in 1956. YPSLs anti-Stalinism fit with his developing politics. In the group, Mike discussed the nature of class society, the primacy of the working class in the struggle for socialism, how capitalists use racism to divide the working class, and how workers consciousness changes through struggle. These ideas informed Mikes beliefs for the rest of his life.

In 1964, Mike moved to Berkeley, California, as a graduate student in political science and became part of the political ferment of the moment. Mike was a leader of the campus Congress of Racial Equality (CORE), and he was on the Steering Committee of the Free Speech Movement (FSM), one of the wellsprings of the 1960s movement for change. The university had imposed a rule, under pressure from corporate politicians like former US senator William Knowland, banning the recruitment of other students to join the civil rights movement.

The FSM not only won free speech at UC Berkeley but also helped spawn a new generation of activists. It was then that Mike, along with well-known Marxist scholar Hal Draper and other young activists, formed the Independent Socialist Club (ISC). The ISC stood for socialism from below, meaning that working people themselves would shape the socialist struggle. It rejected the existing Communist states as another form of class society. The ISC recognized that middle-class students could be an important pool of activists, but that socialists should orient toward the diverse working class.

How an independent party of the working class in the United States would be built was a question that Mike wrestled with his entire political life. Mike told Gong that he understood that

most deeply held political ideas for most people are only changed through experience. People open up to new ideas, and allies and enemies become clearer in the course of struggle. That is why we look for opportunities to engage in electoral struggle while also strengthening the understanding of the need for independent organization and exposing the nature of the Democratic Party.

Mike attempted to put some of these ideas into practice in the development of the Peace and Freedom Party (PFP) in California in 1967.

The Community for New Politics, an organization Mike and other activists participated in, was convinced to get a new, independent third party on the ballot. The idea was to base this new party on the social movements of the day: the massive movement against the war in Vietnam and the civil rights movement. Starting a new party and getting it on the ballot was not an easy task: voters would have to first cancel their registration with the party they had registered with, then reregister with the PFP.

One PFP member had a bus painted in psychedelic colors that he drove around the Bay Area, exhorting people over a loudspeaker to register PFP. Members of the Black Panther Party approached people in the bus looking for help. Huey P. Newton, the chair of the Black Panther Party, had just been jailed because of a shoot-out in Oakland. The Panthers offered to help register people in the black community if the PFP would make Hueys plight more broadly known. Mike led the move to ally with the Panthers to unite the antiwar movement with the movement for black political power.

The PFP got on the ballot, but the party did not thrive. Nonetheless, the PFP brought many young people into political activism for the first time and taught them how to organize. As the electoral expression of the antiwar movement and the Black Power movement in 1967 and early 1968, the PFPs fortunes waned as those movements went in different directions.

When Senator Eugene McCarthy entered the 1968 presidential race on an antiwar agenda, many in the PFP switched course to Get Clean for Gene and joined his campaign. The Black Panther Party became increasingly infiltrated by the FBI and went in more dangerous directions. But for a short period, the mainly white antiwar movement and the Panthers joined forces around the radical demands of Free Huey and, regarding Vietnam, Out Now. Mike led on these issues and on forging an alliance between the two movements.

Following the Berkeley model, other ISCs formed in cities around the country. This federation of local organizations became the International Socialists (IS) in 1969. As the group grew, members took jobs in industry, including auto plants in the Midwest. Mike moved to Detroit in 1975 to join the resident leadership of the IS.

In Detroit, Mike was a mentor to the IS socialist youth group, the Red Tide, which grew among high school students and those recently out of high school. The mostly African-American Red Tide took on local issues at high schools, like stopping the expansion of armed police in schools. A signature national issue was Free Gary Tyler, a young student who was sentenced to death in Louisiana after white students attacked black students at a newly integrated school. Tylers cause was later taken up by legal advocates, and after many appeals, Tyler was released from prison forty-two years later.

Mike served as a friend and teacher (and occasional car mechanic) for the Red Tide. Larry Bradshaw, a former Red Tider, explains:

Many of us met Mike when we were still in high school. The Red Tide, a fusion of several radical high school collectives, became the ISs youth group in 1975. Although we didnt use the term mentor in the 1970s, that is what Mike was for so many of us. He respected the organic leadership of youth, allowing us to grapple with a myriad of organizational and political questions on our own, make mistakes, learn from them and grow. His light-hand of leadership was a gift to Red Tide leaders. Mike was there when he needed to be, prodding and challenging us. In turn, we challenged Mike with our brash, youthful revolutionary impatience. Serious Mike also had his fun side, graciously accepting the nickname The P-Funk given to him by Red Tiders. Many Red Tiders learned our foundational socialist principles from and with Mike: a radical democratic socialism from below, a fierce anti-racism, an implacable anti-imperialism, understanding the degeneration of the Russian Revolution into Stalinism, and the insight that the Democratic Party was neither a strategy nor a tool for liberation.

Another former Red Tider, Kyle Hoppy Hopkins, says:

The Red Tide was the youth group of the IS, and Mike was the liaison between the two organizations. But Mike was so much more to us. Mike was teacher and guide to us. A big brother. Mike sat on our executive committee meetings but didnt vote. He allowed us to work out issues and make mistakes.

We affectionately called him P-Funk, because he was pure, uncut funk. The Bomb! I was only seventeen when I was elected as the organizer of the Red Tide. I was quiet and unsure of my ability to lead. He mentored me in organizing skills, teaching me leadership skills and public speaking and conflict resolution. When I became frustrated and wanted to resign my position, it was Mike who convinced me that I could do the job.

As the youth leader of my church, I have used the lessons that I learned from Mike to mentor the young people who I lead. I am forever grateful to have known Mike.

By the end of the 1970s, the American left was in decline, as was the IS. Mike, along with others, argued for regroupment with other compatible organizations in some manner. These efforts met with limited success. Many socialist groups had collapsed, and others were too ideologically distant from IS politics.

In 1984, however, the IS merged with several small groups to form a broader socialist organization, Solidarity, which continues to the present. In a time of limited left activity, Mike viewed Solidarity as a vehicle to keep socialist ideas alive. He and others published the magazine Against the Current as well as other educational material.

Among his many skills, Mike was a brilliant electrician, and eventually he was able to get skilled trades jobs in a series of auto plants in Detroit. He worked first at the Chrysler Warren Stamping Plant. After being laid off from Warren, he got a job at the Ford River Rouge Complex. After another layoff at the Rouge Plant, Mike ended up at the Chrysler Sterling Heights Assembly Plant (SHAP). His brother Bill was the president of the local union in Sterling Heights, United Auto Workers (UAW) Local 1700, for a number of years. (Mike drove an aging Chrysler, made at that plant, until he died.)

Following his hiring at Sterling Heights, Mike soon took an active role in the ongoing struggles over safety and control of the shop floor. He was asked by the local to lead skilled trades training in the plant, which he did with his insightful understanding of power both political and electrical. He was an important element of the locals in-plant strategy and taught others how to fight management on the shop floor.

While at the Sterling Heights plant, Mike published his own newsletter called, tongue in cheek,Meatballs.The name was a middle finger to management who derided some of the workers as meatballs.Underneath the masthead,Mike wrote that the title came from a Depression-era song with the lyric You gets no bread with one meatball.The newsletter addressed issues that interested Mike, such as democracy, safety, and other plant-wide issues.

Mikes youngest brother, Bill, says, Mike was always there for us, a powerful and progressive example of what a life well-lived could be. Bill, too, was a rank-and-file militant. Because of the ups and downs of the auto industry, he worked at two different auto plants from 1974 to 2018, when he retired; he began work at the Sterling Heights Assembly Plant from 1984 until retirement and was president of Local 1700 at the plant from 1998 until 2013. Bill led struggles against the two-tiered wage scheme at Chrysler and successfully won the fight to keep SHAP open after a threatened closure. With Mike, he organized fights over safety issues and control of the shop floor.

Mike was on the board of Labor Notes for several decades. In the 1980s, he did pioneering work under its auspices on labor-management cooperation schemes popular at the time. Mike was the first person to analyze the system of lean production a management system that was allegedly designed only to increase efficiency and eliminate waste and that was becoming increasingly popular from a workers point of view, dubbing it management by stress and showing how it was designed to force workers to work harder without needing the direct intervention of supervisors. He was also the first to analyze cooperation schemes such as quality circles, quality of work life, and employee involvement, his understanding of which was rooted in his own time as an autoworker at Ford and Chrysler.

His first book for Labor Notes was Inside the Circle: A Union Guide to QWL (1985), followed by (with Jane Slaughter) Choosing Sides: Unions and the Team Concept (1988) and Working Smart: A Union Guide to Participation Programs and Reengineering (1995). Because there was no other source of analysis and advice about how unionists should relate to these programs, Labor Notes became a resource for many unionists who knew there was something wrong.

Mike designed and cotaught a dozen team concept schools for Labor Notes and some unions, including the Communications Workers of America (CWA), that brought together unionists across unions to learn how to fight these programs. He taught that these employee participation schemes were designed to allow management to gain control over the work process and erode the informal standards set by work groups themselves as to reasonable output and speed, and helped workers strategize about how to resist them.

Mike coauthored with Martha Gruelle Democracy Is Power,which argued that democracy made unions stronger in fighting the boss and gave concrete advice about how to involve members, run a union democratically, and work to change your union from below. They argued that democracy was far more than formal practices but rather the presence of the union as a living and breathing force in members lives a force they felt was theirs. Gruelle says:

When we worked on Democracy Is Powertogether, I was honored that Mike invited me to challenge his thinking on the various points. I generally saw that he was right. Mike lived his life helping others learn. If weve absorbed some small part of his wisdom, the labor movement will be stronger, and the world will be better.

In remembering Mike, long-term Labor Notes staffer Jane Slaughter said that Mike was an ideal coauthor and teacher because of his brilliant mind but also because he wanted so much to help workers fight the boss. I learned more from him than from anyone else Ive known.

Mikes commitment to working people was not limited to the United States. Through his work with Labor Notes, Mike met and worked with trade unionists from Brazil, Argentina, Japan, and elsewhere. Yamasaki Seiichi wrote on hearing of Mikes death:

Mike first came to Japan in 1989 to participate in the Asian Labor Solidarity Conference. Since then, he was involved in the Japanese labor movement primarily through the late Hideo Totsuka and the late Ben Watanabe. . . . I served as an interpreter for Mike at the 1989 conference. I remember that he did not make fun of me for not knowing the word deregulation but explained it to me in detail. I also have fond memories of my first visit to the United States in 1997, when I was invited to stay at his home in Detroit. . . . I imagine he finished his life of struggle with satisfaction that the work of the Labor Notes for over forty years has been passed on to the next generation and is growing.

Valter Sanches, former general secretary of IndustriALL Global Union in Brazil, was also influenced by Mike:

In the beginning of the 90s, the books Inside the Circle: A Union Guide to QWL and Choosing Sides: Unions and the Team Concept gave me a different perspective that helped me a lot in negotiating the restructuring of Mercedes-Benz in Brazil as a member of the local workers council. The exchanges I had with Mike in the following years always brought me new ideas for the role of the union and its members and leaders. I fondly remember Mikes generous mentorship.

After he retired from Chrysler in 2007, Mike and Margaret Jordan, his wife and partner and an activist in her own right, moved to Richmond, California, after Margaret inherited her parents house. Richmond is home to the largest oil refinery in the West, and Chevron dominated Richmond politics. A community movement, the Richmond Progressive Alliance, was challenging that domination. Mike and Margaret soon joined the RPA, becoming deeply involved in its work.

The RPA has fought for many issues on behalf of ordinary people: support for public schools and not charter schools, rent control, a $15 minimum wage, and other social justice issues. Mike worked on a campaign to reimagine policing, which was able to transfer money from the police budget to support needed social services such as mental health crisis intervention and services for unhoused residents. He cowrote an article for Jacobin about this campaign, writing, Richmond is leading the way on shifting public resources away from more and more policing and toward social programs that can achieve real public safety.

In 2018, Mike advised Jovanka Beckless campaign for California State Assembly. Although Beckles, a member of the RPA and former city council member, did not win, she came close. In their 2020 book, Bigger than Bernie, Jacobins Meagan Day and Micah Uetricht wrote that the campaign

offers a case study in how to wage class struggle on the campaign trail, and how socialists can use those campaigns even when theyre not successful in winning office to strengthen their own skillsets and relationships and apply to workers struggles on the ground.

Beckles went on to win her DSA-backed race for the regional transit board in 2020.

About Mike, Beckles says,

Words cannot express the sadness and loss I feel. Mike was a mentor, a comrade, and a dear friend to me. When I first met him fifteen years ago, I had no idea what a legend and a legendary mentor he was. I quickly came to discover just how much he had done for so many causes and individuals. Mike was generous and gracious. In addition to the patience he had with my countless political and labor questions, he was truly a friend whom I could count on to pick up his phone to provide political guidance. I sought him out because of his brilliant strategic mind. I wouldnt be where I am without his astute guidance. Mike helped the RPA become the organizing machine that it is today. He was the strategic mastermind behind many of our campaigns for environmental, racial, social, and economic justice, and elected office and labor struggles.

In 2017, young socialists in the East Bay branch of DSA found Mike and Martha Gruelles book, Democracy is Power. Learning that Mike lived nearby in Richmond, they reached out to him. Soon after, Mike joined the branch; he was also a founding member of the Bread and Roses caucus of DSA. Although Mike never had the time to play a leadership role in DSA, he was frequently asked for advice, which he willingly gave. He also played a role in involving DSA members in Jovanka Beckless campaigns for state assembly and for the transit board.

Jeremy Gong, a former member of DSAs National Political Committee and leader in DSAs Bread and Roses caucus who interviewed Mike extensively before his death, viewed Mike as a friend and mentor:

Since 2017, in the heady days of the rebirth of US socialism among a new generation, Mike became a mentor to me and others who had no idea what we were doing. After a life of building socialist organizations and building union and movement struggles, Mike always had excellent and concise advice for us on almost every topic. He always pushed us to go beyond already converted socialists and learn how to build movements and organizations with broader layers of activists. Mikes support of young socialists and his faith in the goodness and power of ordinary people will continue to give us confidence in our mission to transform the world.

(Gong has amassed a list of Mikes writings, which can be found here.)

In his last year, Mike joined with Ken Paff, a friend and fellow labor organizer of more than fifty years who was a longtime organizer with the Teamsters for a Democratic Union (TDU), to form a foundation to help fund and carry on his lifes work, the Social Justice and Solidarity Fund.

Mike was my guide and sometimes my patient critic, as he has been to hundreds of other activists, Paff wrote in his own tribute to Mike:

He followed the work of our TDU movement and was always ready with generous solidarity and helpful ideas for me and other TDU leaders. Just over a year ago, Mikes oncologist told him he had about a year to live. Unlike most of us, he had no bucket list. His goal was to keep doing what he loved: working to make a better community and more just world. On the day he died, he was weak and didnt talk much, but asked to hear about the announcement of the mayoral candidacy in Richmond, California by Mikes friend, Eduardo Martinez. He smiled when I told him it went very well.

Mikes partner and wife, Margaret Jordan, died two years ago. She was a fighter for social justice as well and recognized by many for her key role in the activist community. Mike and Margaret are survived by their beloved daughter, Johanna Parker, and her partner, Matt Sylvester. Mike has three brothers, Bob, Bill, and Jerry, all activists, and numerous nieces and nephews. Mike Parker was caring, thoughtful, creative, and inspirational. His loss is felt by many.

He was also my friend for fifty years. I echo everything everyone has said about him. We also had fun together and laughed a lot. He is simply irreplaceable.

Originally posted here:
Mike Parker, a Life Well-Lived on the Left - Jacobin magazine

The Civic Forum

The idea of the Civic Forum had been discussed in Czech dissident circles as far back as the 1970s. Whats surprising however, is how much it shared with the vision of some forward-thinking communists at the time.

In his book The Prague Spring: Departure into a New World, Martin Schulze Wessel describes the remarkable new conception of the Communist Party that Petr Pithart came up with during the Prague Spring of 1968. Pithart, who had been a party member since 1960, went on to collaborate with Havel in dissident activity, becoming Czech prime minister in 1990.

Like Havel, Pithart did not want to copy the Western parliamentary model which in the minds of the public was associated with the corruption, scandals and fragmented party landscape of the interwar First Republic. Instead, he argued that the Communist Party should be an empty framework, a platform, where the process of continual confrontation of opinions, which are also verified by societys praxis, is organised by the vanguard, who are recognised and respected by society. The Party was to become more a continuum of progressive ideas than a continuum of apparatuses.

Today, this proposal seems strikingly reminiscent of the later Civic Forum, which was an empty framework for the exchange of progressive ideas that emerged from the Velvet Revolution. Both were innovative political formations that were supposed to overcome the limits of both the Eastern and Western systems, in which Havel after Patoka saw a single super-civilisation in crisis.

Yet while Havels ideas seem to overlap with those of reformist communists during the Prague Spring, he did not endorse them in 1968. Instead, he advocated notably, in a dispute with the author Milan Kundera in the late 1960s a return to the normality of Western civilisation.

Somethings wrong here. Is Havels idea of non-party politics really a return to normality? During the Velvet Revolution he argued not only against parties, but against a return to capitalism and for the dissolution of both NATO and the Warsaw Pact.

Whats more, by a return to normal, Havel meant freedom of expression and an end to the arbitrary power of the secret police but he overlooked the fact that Western civilisation was no paragon either in this respect. In the 1960s, the US was waging war in Vietnam and there were mass radical protest movements in the US, France, West Germany and elsewhere. Segregation of the African-American population persisted, while France and Great Britain were or had recently been at war with national liberation movements in their colonies, using brutal tactics of suppression.

How can we explain Havels blindness to these things in his polemic with Kundera? Perhaps Havel just didnt want to admit how radical his ideas were at the time, or that they resonated with those of the Prague Spring because that would have implied a partial endorsement of a communist system he opposed.

Read the original:
Vclav Havel and the meaning of socialism - Open Democracy