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Approval based on results from Phase 3 CheckMate -816 trial showing that neoadjuvant Opdivo with chemotherapy improved event-free survival and pathologic complete response compared to chemotherapy alone
Opdivo with chemotherapy is now the first and only neoadjuvant immunotherapy-based treatment option approved to treat patients with non-small cell lung cancer in the European Union
This decision marks the fourth tumor type in which Opdivo-based regimens have been approved for use in earlier stages of cancer in the European Union, following melanoma, esophageal/gastroesophageal junction cancer and urothelial carcinoma
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%. With this EC decision, Opdivo with chemotherapy becomes the first neoadjuvant immunotherapy-based treatment option approved for patients in the European Union (EU) in this setting.
The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery. The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC.
“While cure is possible for some patients with resectable non-small cell lung cancer via surgery, approximately 30-55% of the patients who have their tumors removed will eventually experience recurrence and ultimately die from their disease, thus creating a strong need for treatment options beyond surgery that can help prevent recurrence,” said Nicolas Girard, M.D., professor of thoracic oncology, Institut Curie and Paris Saclay University, Paris, France. “The importance of the approval of nivolumab combined with chemotherapy for the treatment of certain patients with non-metastatic NSCLC in the EU cannot be overstated – it presents the opportunity to change the way their cancer is treated and offers a solution that may reduce the risk of their cancer returning after surgery.”
The EC approval allows for the use of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of adult patients with resectable NSCLC at high risk of recurrence and with tumor cell PD-L1 expression ≥1% in the 27 member states of the EU, as well as Iceland, Liechtenstein and Norway. Opdivo with chemotherapy has also been approved for the neoadjuvant treatment of patients with resectable NSCLC regardless of PD-L1 expression levels in 21 countries, including the United States, Japan and China, and additional regulatory applications are under review by global health authorities. Primary analyses of pCR, EFS and preliminary overall survival (OS) data from the CheckMate -816 trial were previously presented at medical congresses and published in the New England Journal of Medicine. Three-year data were presented at the European Lung Cancer Congress 2023 demonstrating durable clinical benefits with the combination.
“Although we have seen progress in the treatment of earlier-stage non-small cell lung cancer, a significant number of people still face poor outcomes. Up to 50% of NSCLC cases are resectable, meaning that the tumors can be surgically removed, but surgery alone is not always enough to stop the cancer from coming back,” said Anne-Marie Baird, a patient advocate and president, Lung Cancer Europe. “We are pleased to see the approval of this pre-surgery immunotherapy-based combination by the EMA, which provides an additional option in the early-stage NSCLC space.”
“Opdivo in combination with chemotherapy is now the first and only approved immunotherapy-based neoadjuvant treatment option for non-small cell lung cancer in the EU, and we look forward to offering certain patients in Europe a solution that may help reduce their risk of disease recurrence, progression and death,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. “This approval builds on our commitment to advancing treatment paradigms through immunotherapy research in earlier stages of cancer and reinforces the potential of Opdivo-based options to change outcomes for NSCLC patients across different treatment settings and stages of disease. We offer sincere thanks to the patients, investigators and their staff who helped make this approval possible.”
Opdivo-based options have now been approved for the neoadjuvant or adjuvant treatment of four different cancer types in the EU: NSCLC (CheckMate -816), urothelial carcinoma (CheckMate -274), esophageal/gastroesophageal junction cancer (CheckMate -577) and melanoma (CheckMate -238). In addition, the company has a broad development program in earlier stages of cancer that spans several different tumor types.
CheckMate -816 Efficacy and Safety Results
Results from the CheckMate -816 trial in all-randomized patients regardless of tumor cell PD-L1 expression or stage of disease at minimum follow-up of 21 months include:
