Merck and Pfizer Inc. today announced topline results of the Phase III JAVELIN Gastric 100 study evaluating 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).
"Advanced gastric cancer is a hard-to-treat tumor, and there is a key unmet need for additional treatments. Additionally, it is rarely immunogenic, and to date no immune checkpoint inhibitor has demonstrated superiority to the current standard of care with chemotherapy," said Prof. Dr. Markus Möhler, Head of GI Oncology, Senior Physician Gastroenterology & Endosonography, Johannes-Gutenberg University, Mainz, Germany and coordinating investigator. "As we have yet to define the ideal strategy for incorporating immunotherapy in the continuum of care, the results of JAVELIN Gastric 100 will provide essential information in advancing our understanding and potential treatment options of this challenging disease."
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.