Bristol Myers Squibb (BMS) has announced positive results from a phase 3 trial evaluating Opdivo (nivolumab) as an adjuvant therapy in patients with completely resected stage 2B/C melanoma.
At a pre-specified interim analysis, the phase 3 CheckMate-76K trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo.
The study showed that Opdivo reduced the risk of recurrence or death by 58% versus placebo, with a 12-month RFS of 89% versus 79%. This benefit in RFS was observed across predefined subgroups in the trial.
No new safety signals were observed at the time of the analysis, the company noted, and grade 3/4 treatment-related adverse events were 10% in the Opdivo arm and 2% in the placebo.
Commenting on the positive results, Gina Fusaro, development programme lead, melanoma, BMS, said: “This data adds to our growing body of evidence supporting the clinical benefit of Opdivo for the treatment of melanoma, from the metastatic setting to earlier stages of cancer.
“We are continually seeking to advance our science to develop medicines that can help improve outcomes for people living with cancer.”
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to help the natural T-cell response to cancer, by improving the body’s ability to recognise and destroy cancerous cells.
CheckMate-76K was a randomised, double-blind study which evaluated Opdivo 480mg administered every four weeks for up to 12 months versus placebo in 790 patients with completely resected stage 2B/C melanoma.
Key secondary endpoints of the trial include overall survival, distant metastases-free survival, progression-free survival on next-line therapy, as well as safety endpoints.
Melanoma is a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably. Metastatic melanoma is the deadliest form of the disease and occurs when cancer spreads beyond the surface of the skin to other organs.
The incidence of melanoma has been increasing steadily for the last 30 years, with 99,780 new diagnoses of melanoma and about 7,650 related deaths estimated for 2022 in the US alone. Moreover, the World Health Organization (WHO) estimates that by 2035, melanoma incidence will reach 424,102 globally, with 94,308 related deaths.