Bristol-Myers Squibb (BMS) has received approval from the European Commission (EC) for its PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), to treat advanced (unresectable or metastatic) melanoma in adults regardless of BRAF status.
The approval allows BMS to market melanoma drug in all 28 member states of the EU, in addition to the accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP).
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BMS commercialisation, policy and operations head and senior vice-president Emmanuel Blin said: "We are working relentlessly and at record-breaking speed to build upon our immuno-oncology science to deliver new treatment options, with the goal of improving long-term survival for patients."
The approval was based on data from two Phase III studies, including CheckMate-066 and 037, which evaluated Opdivo across treatment lines and mutational status with a consistent dose of 3mg/kg every two weeks.
CheckMate -066 is a Phase III randomised and double-blind study that compared Opdivo with the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve advanced melanoma.
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The trial demonstrated one-year survival rate of 73% for Opdivo against 42% for DTIC and there was a 58% decrease in the risk of death for patients treated with Opdivo based on a hazard ratio of 0.42, said BMS.
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By GlobalDataCheckMate-037 is a Phase III randomised and controlled open-label study of Opdivo versus investigator’s choice chemotherapy (ICC), including either single-agent dacarbazine or carboplatin plus paclitaxel, in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab), and, if BRAF mutation positive, a BRAF inhibitor.
The study showed an improvement of 32% objective response rate (ORR) in the Opdivo arm compared to 11% in the investigator’s choice chemotherapy arm.
In addition, the approval was based on data from a Phase Ib study (Study-003) in relapsed advanced or metastatic melanoma that showed the first characterisation of Opdivo benefit/risk in advanced melanoma.
Image: Lymph node with almost complete replacement by metastatic melanoma. Photo: courtesy of Gabriel Caponetti.
