Yelena Y. Janjigian, MD, discusses results from the phase III JAVELIN Gastric 100 study evaluating avelumab in gastric or gastroesophageal cancer.
Yelena Y. Janjigian, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses results from the phase III JAVELIN Gastric 100 study evaluating avelumab (Bavencio) in gastric or gastroesophageal (GEJ) cancer.
Although data from the phase III study were eagerly awaited, the agent was not found not improve overall survival (OS) as frontline maintenance following induction chemotherapy in patients with unresectable, locally advanced, or metastatic HER2-negative gastric or GEJ cancer, according to Janjigian.
Avelumab missed both of the trial’s OS-based primary end points. Specifically, the median OS was 10.4 months (95% CI 9.1-12.0) in the avelumab arm versus 10.9 months (95% CI 9.6-12.4) in the chemotherapy arm; the 24-month OS rates were 22.1% (95% CI 16.8-28.0) versus 15.5% (95% CI 10.8-20.9), respectively.
This was a relatively small study considering the question it was trying to answer regarding maintenance therapy, which has been a very exciting research question that has been postulated in gastric cancer, adds Janjigian. Unfortunately, overall, this was a negative study that essentially put a break on maintenance strategies in this disease, according to Janjigian.
Another study examining maintenance ipilimumab (Yervoy) was similarly negative, notes Janjigian. As such, the field needs to go back and really consider how to target this disease, determine what the appropriate therapy is, and how to best select patients based on biomarker studies, concludes Janjigian.