The companies have initiated Phase 3 studies in patients with high-risk melanoma and non-small cell lung cancer
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
Keynote -564 is the first Phase 3 trial to demonstrate superior overall survival (OS) with adjuvant therapy compared to placebo in patients with RCC
Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients
The initiation of the second clinical trial in the INTerpath program represents rapid expansion in research for additional tumor types for individualized neoantigen therapy, V940 (mRNA-4157)
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
The companies will work with investigators to share the results with the scientific community
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
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