The FDA has approved durvalumab in combination with chemotherapy for adults with previously treated metastatic gastric or gastroesophageal junction adenocarcinoma, offering a new treatment option for a challenging cancer.
This approval marks a notable advancement for patients facing advanced gastric cancers,a disease with limited therapeutic options and a poor prognosis. The combination therapy provides a new first-line treatment possibility following disease progression, potentially extending survival and improving quality of life. The decision is based on data from the Phase 3 RAINBOW trial, which demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone.Durvalumab, an anti-PD-L1 immune checkpoint inhibitor, works by helping the body’s immune system recognize and attack cancer cells. The approval expands the use of immunotherapy in gastric cancer, building on recent progress in treating this disease. The RAINBOW trial enrolled 505 patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who had progressed after first-line platinum-based chemotherapy. Patients receiving durvalumab plus chemotherapy showed a median overall survival of 12.6 months versus 11.6 months with chemotherapy alone.
The most common adverse reactions observed in the RAINBOW trial included fatigue, diarrhea, nausea, anemia, and asthenia. The FDA granted the request for durvalumab a Priority Review and Breakthrough therapy designation, expediting the review process due to the potential benefit to patients with a serious condition.
