Pfizer and Merck KGaA’s Bavencio falls short of primary endpoint in Phase 3 gastric cancer trial

pharmafile | November 8, 2019 | News story | Medical Communications, Research and Development Bavencio, Merck KGaA, Pfizer, pharma 

Pfizer and Merck KGaA’s EMD Serono have lifted the lid on new Phase 3 data for Bavencio (avelumab) in the treatment of gastric cancer, and they were not the promising kind.

In evaluating the therapy for maintenance treatment following induction chemotherapy in unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer, the companies found that while it showed clinical activity, it failed to outclass chemotherapy or best supportive care with regards to extend overall survival.

As a result, the therapy failed to meet its primary endpoint in the study for the intent-to-treat population or the PD-L1-positive population. The companies did note that the safety profile for the drug was found to be consistent with previous data.

“Advanced gastric cancer is a hard-to-treat tumour, 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,” commented Professor Dr Markus Möhler, Head of GI Oncology, Senior Physician Gastroenterology & Endosonography at the Johannes-Gutenberg University in Germany and coordinating investigator on the trial. “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.”

Echoing Dr Möhler’s comments, the pair of companies confirmed that the results of the trial would be subject to detailed analysis in order to better understand what went wrong.

Matt Fellows

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