Merck and the Canadian Cancer Trials Group (CCTG) announced results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma. At the final analysis of the study, KEYTRUDA plus chemotherapy significantly improved overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. These late-breaking data are being presented during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (ab abstract #LBA8505) and are being discussed with regulatory authorities worldwide.

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, 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 AL K genomic tumor aberrations, and is: stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic. KEYTRUDA, As a single agent, is indicated to 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 tumors aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA,As a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a =4 cm), II, or IIIA NSCLC.