Bristol Myers Squibb has received the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and chemotherapy.
The CHMP granted positive opinion on Opdivo combination with two cycles of platinum-based chemotherapy to treat adults with metastatic NSCLC, whose tumours have no sensitising EGFR mutation or ALK translocation.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to strengthen the body’s immune system to induce an anti-tumour immune response, and has become a crucial treatment option across the spectrum of cancers.
Yervoy is a recombinant, human monoclonal antibody, designed to bind the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), a negative regulator of T-cell activity, to expand the T-cell activation and contribute to anti-tumour immune response.
The EC would consider the CHMP recommendation in reviewing the Opdivo combination treatment for the regulatory approval in the European Union (EU).
Bristol Myers Squibb vice president and thoracic cancers development lead Abderrahim Oukessou said: “This positive CHMP opinion reflects the potential for Opdivo plus Yervoy with two cycles of chemotherapy to offer the chance for a longer life to patients across subgroups of metastatic NSCLC, a devastating cancer where unmet needs still exist.
“We look forward to the EC’s decision and hope to soon introduce this innovative, dual immunotherapy approach to patients across the EU who may benefit.”
The positive CHMP opinion is based on the Phase 3 CheckMate-9LA trial results
The positive CHMP opinion is based on results from the Phase 3 CheckMate -9LA trial, which met the primary endpoint of superior overall survival (OS) in the intent-to-treat (ITT) population.
The randomised, open-label, multi-centre, clinical trial evaluated Opdivo plus Yervoy combined with histology-based chemotherapy, versus chemotherapy alone, in treating patients with metastatic non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and histology.
The secondary hierarchical endpoints include progression-free survival (PFS) and overall response rate (ORR) evaluated by blinded independent review committee. Exploratory analyses from the study evaluated efficacy measures according to biomarkers.
In the Phase -3 trial, the safety profile of Opdivo combination was similar to the known safety profiles of the immunotherapy and chemotherapy components in first-line NSCLC treatment.
The company said that the Opdivo plus Yervoy with two cycles of chemotherapy combination has been approved in nine countries, including the US, for the current indication.
Potential EC approval would mark the third indication for Opdivo plus Yervoy-based combinations in the EU, after approvals in metastatic melanoma and advanced renal cell carcinoma indications.
Furthermore, the company has unveiled positive results for Opdivo plus CABOMETYX (cabozantinib), in Phase 3 CheckMate -9ER Trial, for treating patients with advanced renal cell carcinoma.
