Based on the recommendation from the independent Data Monitoring Committee that the study is unlikely to succeed, Merck (NYSE:MRK) is terminating the Phase 3 KEYNOTE-598 study evaluating the combination of Keytruda (pembrolizumab) and Bristol Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) compared to Keytruda alone for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) with no EGFR or ALK genomic tumor aberrations.
- The addition of Yervoy showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the primary endpoints, compared to Keytruda alone.
- On the safety front, the combo therapy was associated with higher rates of serious, life-threatening and fatal adverse events compared to Keytruda monotherapy.
- Results will be submitted for presentation at a future medical conference.
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