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Merck KGaA, Pfizer's Bavencio fails to meet phase 3 endpoint for gastric cancer

Merck KGaA and Pfizer Inc.'s Bavencio did not meet the primary endpoint in a phase 3 trial for patients with advanced gastric cancer.

The treatment failed to show superior overall survival as a third-line treatment for unresectable, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma, as compared to chemotherapy.

The companies are also evaluating Bavencio as a first-line maintenance therapy following induction chemotherapy, in another trial within the Javelin program. The trial will continue as planned.

The drug was approved by the U.S. Food and Drug Administration for treating Merkel cell carcinoma and urothelial carcinoma. It also secured priority review for treatment of skin cancer.

Merck and Pfizer created an immuno-oncology spinoff company named iOnctura SA that secured access to the future supply of Bavencio, co-developed and co-commercialized by Merck and Pfizer.