First-line maintenance therapy with Bavencio (avelumab) failed to extend the overall survival of patients with advanced stomach or gastroesophageal junction (GEJ) cancer, as compared to standard care, according to the latest updates of the JAVELIN Gastric 100 clinical trial.
The study was a Phase 3, multicenter, open-label trial (NCT02625610) that evaluated Bavencio as maintenance therapy following initial (induction) chemotherapy in adults with locally advanced or metastatic HER2-negative gastric or GEJ cancer, who could not be treated by surgery (unresectable).
In the trial, Bavencio was compared with the standard care (chemotherapy or best supportive care).
Bavencio belongs to a class of cancer immunotherapy called immune checkpoint inhibitors that work by helping the body’s immune system recognize and kill cancer cells. In this case, Bavencio is a lab-made antibody that blocks the protein programmed death ligand-1 (PD-L1).
The medicine is jointly developed and commercialized by EMD Serono (known as Merck KGaA in Europe) and Pfizer, and is approved, alone or in combination, in the U.S. and Europe for certain advanced skin and kidney cancers.
The JAVELIN Gastric 100 trial enrolled 805 patients who received an initial chemotherapy course for 12 weeks (oxaliplatin, plus either 5-fluorouracil or capecitabine).
Patients whose cancer had not worsened at the end of chemotherapy (499 patients) then were assigned randomly to maintenance treatment with intravenous (in the vein) injections of Bavencio, or maintenance with chemotherapy. Patients in the latter group who could not receive chemotherapy were given the best supportive care.
While Bavencio demonstrated some anti-tumor activity, the trial did not meet its primary efficacy goal, which was to show that Bavencio was superior to standard care in terms of prolonging patients’ lives. The same results were observed if only PD-L1-positive patients were analyzed.
Bavencio’s safety profile was consistent with what was known from prior trials, and no new safety signals were reported.
“Advanced gastric cancer is a hard-to-treat tumor, 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,” Markus Möhler, MD, the trial’s coordinating investigator, said in a press release.
A more detailed analysis of the study is underway to better understand the results. These findings eventually will be shared with the scientific community, EMD Serono announced.
“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,” said Möhler, who also is a professor and head of Gastrointestinal Oncology at Johannes-Gutenberg University, Germany.
