Avelumab maintenance fails to extend OS in advanced gastric, gastroesophageal junction cancers
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A randomized phase 3 trial designed to evaluate avelumab as first-line maintenance therapy for patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction cancer failed to meet its primary endpoints.
The multicenter, open-label JAVELIN Gastric 100 study included 805 patients who had not received chemotherapy for metastatic or locally advanced disease. Investigators enrolled patients regardless of PD-L1 expression.
All patients underwent induction chemotherapy with oxaliplatin and either 5-FU or capecitabine for 12 weeks.
After chemotherapy, 499 patients had disease that did not progress.
Researchers assigned these patients to maintenance avelumab (Bavencio; EMD Serono, Pfizer) — an anti-PD-L1 antibody — or continuation of their same chemotherapy regimen until disease progression. Patients who were unfit for additional chemotherapy received best supportive care.
OS in the entire population, as well as in the PD-L1-positive population — defined as expression of 1% or greater (n = 54) — served as primary endpoints.
Results showed avelumab maintenance failed to prolong OS in the intent-to-treat population (HR = 0.91; 95% CI, 0.74-1.11) or the PD-L1-positive population (HR = 1.13; 95% CI, 0.57-2.23).
“Advanced gastric cancer is a hard-to-treat tumor, and there is a key unmet need for additional treatments,” coordinating investigator Markus Möhler, MD, PhD, head of gastrointestinal oncology and senior physician in gastroenterology and endosonography at Johannes-Gutenberg University in Germany, said in a press release. “Additionally, it is rarely immunogenic, and to date no immune checkpoint inhibitor has demonstrated superiority to the current standard of care with chemotherapy. 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.”
Avelumab’s safety profile appeared consistent with prior studies, and researchers observed no new safety signals.