Merck, Pfizer announce topline results of Phase III JAVELIN Gastric 100 trial evaluating Avelumab

New Delhi: EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. recently 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.

JAVELIN Gastric 100 (NCT02625610) is a Phase III, multicenter, randomized, open-label trial investigating maintenance therapy with avelumab in patients with HER2-negative advanced (unresectable, locally advanced or metastatic) adenocarcinoma of the stomach or of the gastroesophageal junction (GEJ) who have not yet received chemotherapy for the treatment of metastatic or locally advanced disease, in an overall population unselected for PD-L1 expression. A total of 805 patients were enrolled to receive induction (initial) chemotherapy with oxaliplatin and either 5-fluorouracil (5-FU) or capecitabine for 12 weeks. Of these, 499 patients whose disease had not progressed at the end of the 12 weeks of chemotherapy treatment were randomly assigned to receive either avelumab as a maintenance treatment or continuation of the same chemotherapy regimen until disease progression. Patients unfit for further chemotherapy received best supportive care. The primary endpoints are overall survival in all randomized patients or in the PD-L1+ population (≥1%).

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 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," 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."

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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.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.6-8 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

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