FDA grants priority review to Opdivo for gastric, esophageal cancer indications
The FDA granted priority review to nivolumab for two gastrointestinal cancer indications, according to the agent’s manufacturer.
One designation applies to use of the agent with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.
The other designation applies to use of the drug as adjuvant therapy for patients with resected esophageal or gastroesophageal junction cancer.
Nivolumab (Opdivo, Bristol Myers Squibb) is an anti-PD-1 antibody.
The FDA based the priority review for the first-line indication on results of the randomized phase 3 CheckMate -649 trial, which included patients with previously untreated, non-HER2-positive advanced or metastatic gastric or gastroesophageal junction cancer or esophageal adenocarcinoma.
Researchers assigned patients to nivolumab plus chemotherapy, nivolumab plus ipilimumab (Yervoy, Bristol Myers Squibb), an anti-CTLA-4 monoclonal antibody, or chemotherapy alone. Treatment continued for up to 2 years, or until disease progression, unacceptable toxicity or consent withdrawal.
As Healio previously reported, results showed the nivolumab-chemotherapy regimen significantly improved OS and PFS among patients whose tumors expressed PD-L1 with a combined positive score of 5 or higher. Researchers also reported a significant OS benefit with the combination in the overall study population.
The FDA is expected to make a decision on this application by May 25.
“The positive results of the CheckMate -649 trial are potentially practice-changing, and we look forward to working with the FDA to possibly bring the first immunotherapy-based treatment option to front-line patients, for whom no novel therapies have been made available in the last decade,” Ian M. Waxman, MD, development lead for gastrointestinal cancers with Bristol Myers Squibb, said in a company-issued press release.
The FDA based the priority review for the adjuvant therapy indication on results of the randomized phase 3 CheckMate -577 trial, which included 794 patients with resected esophageal or gastroesophageal junction cancer who received neoadjuvant chemoradiation therapy and did not achieve pathological complete response.
Researchers assigned 532 patients to nivolumab and 262 patients to placebo. As Healio previously reported, results showed nivolumab doubled median DFS, the study’s primary endpoint. Follow-up for OS — a secondary endpoint — is ongoing.
The FDA is expected to make a decision on this application by May 20.
“The FDA’s acceptance of our application marks important progress toward our goal of advancing treatment options for patients with esophageal or gastroesophageal junction cancer, in this case in early-stage disease,” Waxman said in a release. “We look forward to working with the FDA to potentially bring Opdivo to these patients, who face a critical unmet need and remain at high risk for disease recurrence.”