Avelumab Maintenance Therapy in Gastric Cancer: JAVELIN Gastric 100 Trial
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On November 8, 2019, Pfizer announced the results of the JAVELIN Gastric 100 Phase 3 clinical trial. This trial investigated the efficacy and safety of Avelumab (Bavencio), an anti-PD-L1 antibody, as a maintenance monotherapy for patients with unresectable, metastatic, HER2-negative gastric or gastroesophageal junction (GEJ) cancer who had not progressed following first-line platinum-based chemotherapy.
Study Design: JAVELIN Gastric 100 Trial
The international, randomized, open-label Phase 3 trial compared two maintenance strategies:
- Avelumab Group: Avelumab monotherapy.
- Chemotherapy Group: Continuation of first-line chemotherapy or best supportive care.
The primary endpoints were overall survival (OS) in the total population and OS in the PD-L1-positive population (CPS ≥1).
Key Results
The study did not meet its primary endpoints of demonstrating superior overall survival with Avelumab compared to standard chemotherapy:
- Total Population OS: While Avelumab reduced the risk of death by 9% compared to chemotherapy, the difference was not statistically significant.
- PD-L1 Positive Population OS: In patients with PD-L1-positive tumors, the risk of death actually increased by 13% in the Avelumab group compared to the chemotherapy group, showing no survival benefit.
Safety Profile
The safety profile of Avelumab in this trial was consistent with previous clinical studies, with no new safety signals identified.
Expert Conclusion
Dr. Markus Möhler noted that treatment options for HER2-negative metastatic gastric cancer remain limited. While this specific trial did not demonstrate a superiority of Avelumab as a maintenance therapy over standard care, research continues to explore the role of immune checkpoint inhibitors in various settings for gastric and GEJ cancers.
Source: Pfizer Press Release - JAVELIN Gastric 100 Trial Update
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