Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been recommended by the European Medicines Agency’s human medicines committee as an adjuvant treatment in adults and adolescents with completely resected stage 2B or 2C melanoma.
The therapy is already approved in the EU for use in certain melanoma patients. If approved for this latest indication, Opdivo would become the only PD-1 inhibitor authorised as an adjuvant treatment for patients within stages 2B, 2C and 3, as well as stage 4 resected melanoma.
The Committee for Medicinal Products for Human Use’s (CHMP) decision was supported by positive safety and efficacy results from the phase 3 CheckMate-76K trial, in which Opdivo reduced the risk of recurrence or death by 58% versus placebo at a minimum follow-up of 7.8 months.
The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.
Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses.
Gina Fusaro, vice president, global programme lead, BMS, said: “Many patients with stage 2B or stage 2C melanoma face the difficult reality of disease recurrence within five years of surgery. In the data from the CheckMate-76K trial, Opdivo was shown to significantly reduce the risk of disease recurrence for these patients.
“The CHMP’s recommendation brings us closer to potentially providing Opdivo for use in treating additional earlier stages of melanoma in the adjuvant setting, addressing an unmet need for patients in the EU.”
Opdivo is a PD-1 immune checkpoint inhibitor that is designed to utilise the body’s own immune system to help restore anti-tumour immune response.
The therapy is currently approved in more than 65 countries, including the US, EU, Japan and China, for a range of indications such as lung, kidney and gastric cancers.
Just under a month ago, the European Commission approved the therapy in combination with platinum-based chemotherapy to treat certain non-small cell lung cancer patients.