Positive results from Merck’s Keytruda in Gastroesophageal Junction Adenocarcinoma

CAR-T Digest - August 2020

20 Jun 2023: Keytruda / Gastroesophageal Junction Adenocarcinoma / Merck: Phase 3 KEYNOTE-585 Trial met one of its primary endpoints of pCR

Merck announced topline results from Phase 3 KEYNOTE-585 study of Keytruda + chemotherapy as neoadjuvant treatment in gastroesophageal junction adenocarcinoma
The results demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone
For the Primary endpoint of event-free survival (EFS), there was an improvement in the Keytruda arm; however, results did not meet statistical significance per the pre-specified statistical analysis plan
OS was not formally tested since superiority was not reached for EFS
The safety profile of Keytruda was consistent with that observed in previously reported studies
Results will be presented at an upcoming medical meeting