Bristol Myers Squibb (BMS) has announced positive results from a phase 3 trial evaluating Opdivo (nivolumab) as a single agent in the adjuvant setting in patients with completely resected stage 2B/C melanoma.
The phase 3 CheckMate-76K trial met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival versus placebo at a pre-specified interim analysis. No new safety signals were observed at the time of the analysis, the company noted.
CheckMate-76K was a randomised, double-blind study which evaluated Opdivo 480mg administered every four weeks for up to 12 months compared to placebo.
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 characterised that develops when pigment-producing cells located in the skin grow uncontrollably. The incidence of melanoma has been increasing steadily for the last 30 years, BMS reported, 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.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, designed to try to help the natural T-cell response to cancer, by improving the body’s ability to recognise and destroy cancerous cells.
Commenting on the positive results, Gina Fusaro, development program lead, melanoma, BMS, said: “The results of the CheckMate -76K study represent a significant advancement for patients with stage 2B/C melanoma and an extension of our legacy in the treatment of melanoma.
“Recurrence represents a life-altering event for people living with cancer. Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal of improving patient outcomes.”
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and is currently approved in more than 65 countries, including the EU, the US, Japan and China.
The company will complete a full evaluation of the CheckMate-76K data, and outlined its plans to share the results at an upcoming medical conference, as well as with health authorities.