Merck and Pfizer have revealed that a Phase III trial assessing avelumab in patients with gastric cancer after two prior therapeutic regimens failed to hit its primary target of showing an improvement in survival.
The Phase III JAVELIN Gastric 300 trial was pitting third-line use of single-agent avelumab against physician’s choice of chemotherapy in patients with unresectable, recurrent or metastatic gastric or gastroesophageal junction (GEJ).
“Gastric cancer in the third-line setting is a particularly hard-to-treat and heterogeneous disease, and importantly, this was the first trial conducted with a checkpoint inhibitor compared to an active chemotherapy comparator rather than placebo in a global patient population,” said Luciano Rossetti, global head of R&D at the Biopharma business of Merck.
“We remain committed to our ongoing gastric cancer program with avelumab including the JAVELIN Gastric 100 study in the first-line switch maintenance setting.”
Data from the JAVELIN Gastric 300 will be further examined to help better understand the results, and will also be submitted for presentation at an upcoming medical congress, the firms noted.
Gastric cancer is the fifth most common cancer but the third most common cause of cancer death: in 2012, there were around 950,000 new cases and 723,000 deaths worldwide.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody, approved in the US and EU under the trade name Bavencio to treat Merkel cell carcinoma, and also in the US for urothelial carcinoma.