On August 22, 2024 The U.S. Food and Drug Administration (FDA) reported that it will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) on September 26, 2024, to discuss a class-wide risk-benefit assessment of PD-L1 expression level cutoffs for immune checkpoint inhibitors in gastric and esophageal cancers. Cumulative data have shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in these patient populations. As part of this meeting, Bristol Myers Squibb will meet with the Committee to discuss approved U.S. indications for Opdivo (nivolumab)-based combinations in advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC), and unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) (Press release, Bristol-Myers Squibb, AUG 22, 2024, View Source [SID1234646054]).
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"With proven survival benefits, Opdivo-based regimens have changed the outlook for patients with GC, GEJC, EAC and ESCC regardless of PD-L1 status," said Ian M. Waxman, M.D., vice president, senior global program lead, late development, oncology, Bristol Myers Squibb. "We look forward to the opportunity to discuss the importance of Opdivo-based regimens as treatment options for appropriate gastric and esophageal cancer patients more in depth with the Committee."
Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy was granted full approval by the FDA for the treatment of adult patients with advanced or metastatic GC, GEJC, and EAC in 2021. This approval was supported by results of the Phase 3 CheckMate -649 trial. In CheckMate -649, Opdivo plus chemotherapy demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared with chemotherapy in all randomized patients regardless of PD-L1 status. CheckMate -649 is the largest Phase 3 trial of an immunotherapy in advanced or metastatic GC, GEJC, and EAC.
Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy and Opdivo in combination with Yervoy (ipilimumab) were granted full FDA approval in 2022 for the first-line treatment of adult patients with unresectable advanced or metastatic ESCC. This approval was supported by results of CheckMate -648, the largest Phase 3 trial of an immunotherapy in first line ESCC, which showed that the two Opdivo-based regimens demonstrated a statistically significant and clinically meaningful OS benefit compared to chemotherapy alone in all randomized patients who were enrolled regardless of PD-L1 status.
Opdivo and Opdivo-based combinations are important treatment options for multiple types of cancers with FDA approvals across 11 cancer types. In addition to GC, GEJC, EAC, and ESCC, Opdivo and Opdivo-based combinations are also approved in melanoma, renal cell carcinoma, urothelial carcinoma, classic Hodgkin lymphoma, colorectal cancer, non-small cell lung cancer, malignant pleural mesothelioma, hepatocellular carcinoma and squamous cell carcinoma of the head & neck.