Phase III JAVELIN Gastric 100 study of Bavencio fails to meet endpoint in gastroesophageal junction (GEJ) cancer.- Merck/Pfizer
Merck and Pfizer Inc. announced topline results of the Phase III JAVELIN Gastric 100 study evaluating 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 continuation of chemotherapy or best supportive care. While the study showed clinical activity for avelumab in this setting, it did not meet the primary endpoints of superior overall survival compared with the standard of care in the overall intent-to-treat population (n=499; HR: 0.91; 95% CI: 0.74, 1.11) or the PD-L1�positive population (n=54; HR: 1.13; 95% CI: 0.57, 2.23).
No new safety signals were observed, and the safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program. A detailed analysis of the Phase III JAVELIN Gastric 100 study is being conducted to better understand the results, and findings will be shared with the scientific community.
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