Nivolumab Could Increase Rate of Recurrence Free Survival By More Than 90% In Patients With Resected Stage 2B Melanoma

Nivolumab may cut the risk of death or recurrent cancer by more than half, according to phase 3 trial results.

Nivolumab (Opdivo; Bristol Myers Squibb) was found to significantly benefit recurrence-free survival (RFS) in patients with stage 2B and 2C and resected melanoma, based on the results of the phase 3 CheckMate -76K trial, which evaluated nivolumab as an adjuvant therapy against placebo. The study data demonstrated that risk of death or recurrence for patients given nivolumab was reduced by 58% compared to the placebo.

“Within 5 years after surgery, one third of stage [2]B and one half of [2]C patients see their cancer return. Helping reduce that risk remains a need to be addressed when it comes to treating melanoma,” said Georgina Long, AO, MD, PhD, co-medical director of Melanoma Institute Australia (MIA), in a press release.

At the interim analysis, the CheckMate -76K met its primary endpoint of relapse-free survival (RFS), which was statistically significant and clinically meaningful. After 12 months on nivolumab, rates of RFS among patients were 89%, compared to 79% for those given the placebo. Specifically, the 12-month RFS rate for patients with stage 2B melanoma was a significant 93%; in stage 2C melanoma patients, this rate was still high at 84%. Among the placebo groups, rates of RFS were 84% and 72%, respectively.

CheckMate -76K is a randomized phase 3, double-blind study evaluating nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor that encourages the body’s own immune system to fight cancer, as a treatment for those with resected stage 2 melanoma. This treatment shared a consistent safety profile with previous reports. Treatment-related adverse events of grade 3/4 stage affected 10% of the clinical group and 2% of the placebo group.

Melanoma is the result of uncontrolled growth of pigment-producing cells (melanocytes) in the skin. Metastatic melanoma is the deadliest form because the cancer can spread to other organs. It is estimated that nearly 100,000 people will die from the disease within the next 15 years.

Nivolumab is currently indicated to treat patients with metastatic melanoma as a combination treatment. It is also indicated as a combination treatment for metastatic non-small cell lung cancer and renal cell carcinoma. Nivolumab is currently being studied in a program to treat 7 different types of tumors.

“We are continually seeking to advance our science to develop medicines that can help improve outcomes for people living with cancer,” Gina Fusaro, PhD, development program lead, melanoma, Bristol Myers Squibb, said in the press release.

Study data is being presented at the 2022 Society for Melanoma Research (SMR) Annual Meeting in Edinburgh, Scotland, from October 17 to October 20, 2022.

“The data from CheckMate -76K show that treating with nivolumab in the adjuvant setting… could be an important treatment option for this patient population,” Long said in the press release.

Reference

Bristol Myers Squibb. Bristol Myers Squibb Presents Data from CheckMate -76K Showing Opdivo (nivolumab) Reduced the Risk of Recurrence or Death by 58% Versus Placebo in Patients with Completely Resected Stage IIB or IIC Melanoma. BMS website. October 19, 2022. Accessed on October 20, 2022. https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Presents-Data-from-CheckMate--76K-Showing-Opdivo-nivolumab-Reduced-the-Risk-of-Recurrence-or-Death-by-58-Versus-Placebo-in-Patients-with-Completely-Resected-Stage-IIB-or-IIC-Melanoma/default.aspx