Merck Announces Phase 3 KEYNOTE-B96 Trial Met Primary Endpoint of Progression-Free Survival in Patients with Platinum-Resistant Recurrent Ovarian Cancer Whose Tumors Expressed PD-L1 and in All Comers

Published: 2025-05-15 06:45:00 ET MRK

Published on 05/15/2025 at 06:45, updated on 05/15/2025 at 07:50

Merck announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers. With more than 20 clinical trials in more than 18,000 patients around the world, Merck is driving innovative research to purposefully advance standards of care in women's cancers. 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: 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. 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, as determined by an FDA- approve test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Microsatellite Instability -High or Mismatch RepairDeficient Cancer: KEYTRU DA is indicated for the treatment of patients with unresectable or prostate MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA- approval test. KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first -line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastric junction (GEJ) adenocarcinoma whose tumors express PD-L 1 (CPS 1) as determined by an FDA the FDA-approved test. KEYTRUDA is indicated to the treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD- L1 (CPS 1) asetermined by an FDA-approved test.

KEY TRUDA, as a single agents, is indicated for the treatment of patient with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L2 (CPS 1) as determination by an FDA-approved test; KEYTRUDA, as an FDA-approved test; and uncertainties include but are not limited to, general industry conditions and are not candidates for curative surgery or radiation; Tumor Mutational Burden-High Cancer: KeyTRUDA is indicated for The treatment of adult and pediatric patients With unresectable or metastatic tumormutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb] solid tumors, as determined by a FDA-approved test, that have progressed following previous treatment and who have no satisfactory alternatives. R risks and uncertainties include but are not Limited to, general industry conditions and risks and uncertainties include but are no limited to, general industry conditions.