These trials included: KEYNOTE-716 in stage IIB and IIC melanoma KEYNOTE-054 in stage III melanoma KEYNOTE-564 in renal cell carcinoma KEYNOTE-522 in triple-negative breast cancer KEYNOTE-629 in cutaneous squamous cell carcinoma and KEYNOTE-057 in Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer. In addition to KEYNOTE-091, six other pivotal trials evaluating a KEYTRUDA-based regimen in patients with earlier stages of cancer met their primary endpoint(s). for patients with stage IB (≥4 centimeters) to IIIA non-small cell lung cancer following surgical resection regardless of PD-L1 expression.” “If approved, KEYTRUDA would be the first adjuvant immunotherapy-based option in the U.S. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

The acceptance of our application demonstrates the progress we are making in earlier lines and earlier stages of certain cancers across our oncology portfolio,” said Dr. “KEYTRUDA is foundational in the treatment of metastatic non-small cell lung cancer. Results were recently presented at a European Society for Medical Oncology (ESMO) Virtual Plenary. The safety profile of KEYTRUDA in this study was consistent with that observed in previously reported studies. The trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1 (TPS ≥50%) as well as other secondary endpoints. Disease-free survival in patients whose tumors express PD-L1 (TPS ≥50%) did not reach statistical significance per the pre-specified statistical plan. At the interim analysis of this study, adjuvant treatment with KEYTRUDA demonstrated a significant improvement in DFS for patients regardless of PD-L1 expression compared to placebo. The study has dual primary endpoints of disease-free survival (DFS) regardless of PD-L1 expression and DFS in patients whose tumors express PD-L1 (tumor proportion score ≥50%).

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of January 29, 2023, however, further data may be provided during the review process that may delay this date. The sBLA is based on data from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP). Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA for the adjuvant treatment of patients with stage IB (≥4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Acceptance based on results from the Phase 3 KEYNOTE-091 trial, the seventh positive pivotal study evaluating a KEYTRUDA-based regimen in earlier stages of cancer

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