A Phase 3 clinical trial, JAVELIN Gastric 100, evaluating Pfizer (NYSE:PFE) and alliance partner Merck KGaA’s (OTCPK:MKGAY) Bavencio (avelumab) as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer versus standard of care failed to achieve the primary endpoint of overall survival (OS).
Avelumab, a PD-L1 inhibitor, did not sufficiently separate from chemo or best supportive care in the overall intent-to-treat population or the PD-L1-positive population as measured by OS over at least three years.
On the plus side, no new safety signals were observed.
Data analysis is ongoing. Final results will be shared with the scientific community.
Bavencio is currently approved in the U.S. for Merkel cell carcinoma, urothelial carcinoma and renal cell carcinoma (with Inlyta).
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