Bavencio Fails to Increase Survival of Advanced Gastric Cancer Patients in Phase 3 Trial

Bavencio Fails to Increase Survival of Advanced Gastric Cancer Patients in Phase 3 Trial

Bavencio (avelumab) failed to increase overall survival of unresectable, recurrent, or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients in a Phase 3 trial, Merck KGaA and Pfizer announced.

The JAVELIN Gastric 300 trial (NCT02625623) included patients whose disease progressed following two prior therapies and compared Bavencio with physician’s choice chemotherapy as a third-line treatment.

“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,” Luciano Rossetti, MD, executive vice president of global head of research and development at the Biopharma business of Merck KGaA, said in a press release.

Bavencio is an antibody that blocks PD-L1, a protein that is often produced by cancer cells to escape the body’s immune system. Like other immune checkpoint blocker, the drug works by boosting the immune system’s ability to recognize and eliminate cancer cells.

JAVELIN Gastric 300 is an open-label clinical study designed to evaluate whether Bavencio was better than chemotherapy at improving the survival of patients with advanced gastric and GEJ cancer who had failed two prior therapies.

Usually, PD-L1 levels are used to predict if a patient will respond PD-1/PD-L1 inhibitors, and trials only include a subset of patients with high PD-L1 levels who are likely to respond. In this trial, however, participants were included regardless of their PD-L1 status.

The study included 371 patients with unresectable, recurrent or metastatic gastric or GEJ adenocarcinoma, enrolled in 147 sites across Asia, Australia, Europe, and America.

Participants were randomized to receive Bavencio plus best supportive care or chemotherapy – Taxol (paclitaxel) or Camptosar (irinotecan) – plus best supportive care.

While the trial failed to meet its primary outcome of superior survival, researchers will continue to analyze the data to determine if any of the secondary endpoints – progression-free survival, best overall response, and quality of life measures – were met.

The safety profile of Bavencio was consistent with previous reports from other studies included in the JAVELIN clinical development program.

The data will be submitted for presentations at upcoming medical meetings.

“Data from this study will provide valuable information for physicians treating this late stage disease,” Rossetti said. “We remain committed to our ongoing gastric cancer program with avelumab [Bavencio] including the JAVELIN Gastric 100 study [NCT02625610] in the first-line switch maintenance setting.”

The U.S. Food and Drug Administration has approved the use of Bavencio for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have failed to respond to platinum-containing chemotherapy, and for the treatment of metastatic Merkel cell carcinoma. Bavencio was also the first immunotherapy approved in Europe to treat adult patients with aggressive metastatic Merkel cell carcinoma.

“With approvals for two cancers in 2017, our companies have made tremendous progress with avelumab on behalf of patients this year, and we are confident that our broad clinical development program in both monotherapy and combinations across a range of cancers will continue to bring new potential treatment options to patients,” said Chris Boshoff, MD and PhD, senior vice president and head of immuno-oncology, early development and translational oncology, Pfizer Global Product Development.