If approved, the Opdivo regimen would be the first and only immunotherapy-based option authorized for use before surgery in patients with non-small cell lung cancer ( NSCLC) in the European Union
Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC
Opdivo-based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer
Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its 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.
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.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.