EMA Validates BMS’s Application for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Resectable Non-Small Cell Lung Cancer

The European Medicines Agency (EMA) has validated Bristol Myers Squibb-s type II variation application for Opdivo (nivolumab) in combination with chemotherapy for the neoadjuvant treatment of patients with resectable stage IB to IIIA non-small cell lung cancer (NSCLC), based on results from the CheckMate -816 trial. Validation of the application confirms the submission is complete and begins the EMA’s centralized review procedure.

“Lung cancer is the leading cause of cancer deaths globally, and unfortunately cases caught in earlier stages continue to contribute to this statistic, with up to 55% of patients who undergo surgery ultimately relapsing and dying of their disease,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “The CheckMate -816 trial has shown the potential for Opdivo with chemotherapy to address the need for new options that can be given to patients before surgery to help prevent recurrence and improve long-term outcomes. We look forward to working with the European Medicines Agency with the goal of achieving the first approval of a neoadjuvant immunotherapy-based combination for non-small cell lung cancer patients in the European Union.”

In the pivotal CheckMate -816 study, the first positive Phase 3 trial with an immunotherapy in the neoadjuvant setting of NSCLC, three cycles of Opdivo in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) versus chemotherapy alone when given before surgery. The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC. The pCR data from CheckMate -816 were presented at the American Association for Cancer Research (AACR) Annual Meeting 2021, and the EFS results will be presented in a clinical trials plenary session at the AACR Annual Meeting 2022 on April 11, 2022, beginning at 10:15 a.m. CT, in New Orleans, Louisiana, BMS said in its press release.

The company noted that based on the results of CheckMate -816, the U.S. Food and Drug Administration approved Opdivo in combination with chemotherapy for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting in March 2022.

To date, Opdivo-based therapies have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: NSCLC, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma. In addition to the neoadjuvant setting, Bristol Myers Squibb and collaborators are exploring the use of adjuvant and peri-operative immunotherapy, as well as immunotherapy in association with chemoradiation, in non-metastatic NSCLC.