29 May 2023 | Monday | Regulatory
If approved, Opdivo with chemotherapy would be the first and only neoadjuvant immunotherapy-based option authorized to treat patients with non-small cell lung cancer in the European Union
Bristol Myers Squibb (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.
“The devastating reality is that despite progress in lung cancer treatment, many patients still ultimately end up relapsing and potentially dying of their disease,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Based on the results of the CheckMate -816 trial, Opdivo with chemotherapy is the first immunotherapy-based regimen to reduce the risk of disease recurrence, progression and death in resectable NSCLC when given before surgery. The CHMP’s recommendation moves us another step closer to addressing the pressing need to offer certain patients in the European Union a chance to change the course of their disease with an effective and tolerable pre-surgical option that may help reduce the risk of relapse.”
The positive opinion is based on results from the CheckMate -816 trial, which demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) with three cycles of Opdivo in combination with chemotherapy compared to chemotherapy alone when given before surgery. The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC. Primary analyses of pCR, EFS and preliminary overall survival (OS) data from CheckMate -816 were previously presented at medical congresses and published in the New England Journal of Medicine. Three-year data demonstrating durable clinical benefits with the combination were presented at the European Lung Cancer Congress 2023. CheckMate -816 is ongoing to assess key secondary endpoints and subgroup analyses, including OS, which continue to mature.
To date, Opdivo with chemotherapy has 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. Opdivo-based treatments have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -816 clinical trial.