The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD; NYSE: MRK) for its blockbuster drug Keytruda (pembrolizumab). The drug is now approved in combination with trastuzumab, originator Roche’s (SWX: ROG) Herceptin, and chemotherapy as a first-line therapy against locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing PD-L1 in adults.
Significant Improvements in Clinical Endpoints
The approval is supported by late-stage data that demonstrated significant improvement in progression-free survival (PFS) and objective response rate (ORR) in the experimental arm administering the anti-PD-1 biologic. These improvements were among the primary endpoints of the study, indicating the potential benefits of the combination therapy for patients with HER2-positive gastric or GEJ adenocarcinoma.
Implications for HER2-Positive Cancer Treatment
This expanded indication for Keytruda further solidifies its position in the treatment landscape for HER2-positive cancers. The combination therapy offers a new treatment option for patients with locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, potentially improving outcomes and providing an alternative to standard chemotherapy.-Fineline Info & Tech
