Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.
- Continued approval of this indication may be contingent upon verification and description of clinical benefit at the final analysis of the KEYNOTE-811 study.
- The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.
- In the U.S., KEYTRUDA is also approved for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, based on results from KEYNOTE-859.
- Merck has an extensive clinical development program evaluating KEYTRUDA in gastrointestinal cancers and is continuing to study KEYTRUDA for multiple uses in gastric, hepatobiliary, esophageal and colorectal cancers.