Bristol-Myers Squibb announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Opdivo (nivolumab) for the treatment of locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC) after prior chemotherapy in adults. The company noted that the drug "is the first PD-1 immune checkpoint inhibitor to receive a positive opinion from the CHMP" in advanced NSCLC.
The decision was supported by findings from the Phase III CheckMate-017 and Phase II CheckMate-063 trials. In the CheckMate-017 study, which included 272 patients with advanced or metastatic squamous cell NSCLC, Opdivo significantly prolonged overall survival (OS) versus docetaxel irrespective of PD-L1 expression, with a 41 percent reduction in the risk of death. Meanwhile, in the CheckMate-063 trial, Opdivo was associated with a one-year survival rate of 40.8 percent and a median OS of 8.2 months in patients with metastatic squamous NSCLC that progressed despite treatment with a platinum-based therapy and at least one systemic regimen.
Last year, Opdivo became the first PD-1 inhibitor marketed anywhere in the world following its launch in Japan at a cost of $143 000 per year. In December 2014, the therapy was awarded accelerated approval by the FDA for the treatment of unresectable or metastatic melanoma in patients who no longer respond to other treatments, while earlier this year the drug gained expanded clearance for the treatment of patients with advanced squamous NSCLC who progressed on or after platinum-based therapy (for related analysis, see ViewPoints: Bristol-Myers Squibb set to cash in on speedy approval of Opdivo in lung cancer). Last month, the CHMP issued a positive opinion for Opdivo in advanced melanoma.
Meanwhile, Merck & Co. recently announced plans to seek expanded US approval for its PD-1 inhibitor Keytruda (pembrolizumab), which is currently authorised in the country for the treatment of melanoma, to include patients with NSCLC whose disease progressed on or following platinum-containing chemotherapy. For further analysis, see ViewPoints: Merck & Co. ups its game again, but Bristol-Myers Squibb takes lead in NSCLC PD-1 race.
Separately on Friday, Merck announced that the CHMP recommended approval of Keytruda for the treatment of advanced melanoma, as both first-line therapy and in previously treated patients.
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