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# Merck/Pfizer Avelumab Flunks Gastric Cancer Trial
- URL: https://www.fdaweb.com/merck-pfizer-avelumab-flunks-gastric-cancer-trial/
- Published: 2017-11-29T12:00:00.000Z
- Updated: 2026-09-14T23:04:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140223

Merck KGaA and Pfizer have reported that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall survival with avelumab compared with physician’s choice of chemotherapy. The trial investigated avelumab as a third-line treatment for unresectable, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma patients whose disease progressed following two prior therapeutic regimens, regardless of programmed death ligand-1 (PD-L1) expression. The companies say that avelumab’s safety profile was consistent with that observed in the overall JAVELIN clinical development program.

**Merck and Pfizer are operating under an alliance to** explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The alliance is evaluating avelumab as a monotherapy and in combination regimens for treating cancer. Earlier this year, FDA grantd accelerated approval for Bavencio (avelumab) for treating adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. The therapy works by targeting the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells), an [agency release](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwMzIzLjcxNDcxMDMxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDMyMy43MTQ3MTAzMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDAwMTE0JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&101&&&https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says. By blocking these interactions, Bavencio may help the body’s immune system attack cancer cells, it says.

The companies are examining the JAVELIN data further and will submit it for presentation at an upcoming medical congress. The data do not have any impact on avelumab’s current approval or use, they say.