Bristol-Myers Squibb (BMS) has received approval from the European Commission for its Nivolumab BMS to treat locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy.
The approval allows the firm to market the drug in all 28 EU member states.
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Approval was based on data from two studies, including Phase III CheckMate -017 and Phase II CheckMate -063.
CheckMate -017 is an open-label and randomised clinical trial that assessed nivolumab 3mg/kg intravenously over 60 minutes every two weeks versus standard of care, docetaxel 75mg/m2 intravenously administered every three weeks in patients with advanced SQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen.
The trial results demonstrated a 41% reduction in the risk of death with a one-year survival rate of 42% for nivolumab versus 24% for docetaxel.
CheckMate -063 is a single-arm and open-label study that comprised patients with metastatic SQ NSCLC who had progressed after two or more lines of therapy.
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By GlobalDataThe trial’s primary endpoint was 14.5% with an estimated one-year survival rate of 41% and its safety profile in the study is consistent with prior clinical studies.
Nivolumab is claimed to be the first PD-1 immune checkpoint inhibitor to receive regulatory approval, when Ono Pharmaceutical obtained manufacturing and marketing approval in Japan to treat patients with unresectable melanoma.
In 2011, BMS signed collaboration agreement with Ono Pharmaceutical to develop and commercialise Nivolumab worldwide except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound.
In July 2014, both firms expanded collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.
Image: Non-small cell carcinoma. Photo: courtesy of Yale Rosen.
