Bristol Myers Squibb’s PD-1 Inhibitor Opdivo Receives FDA Approval, Reducing Risk of Recurrence by Nearly 60% in Stage IIB/IIC Melanoma

▎WuXi

Edited by Kant Content Team

Bristol-Myers Squibb recently announced that the重磅 PD-1 inhibitor Opdivo (nivolumab) has received approval from the U.S. FDA for adjuvant treatment of adult and pediatric patients aged 12 years and older with completely resected stage IIB or IIC melanoma. This approval is primarily based on the phase 3 clinical trial CheckMate-76K, which showed that,Compared with placebo, Opdivo reduced the risk of recurrence, new primary melanoma, or death by 58% (HR=0.42; 95% CI: 0.30-0.59; P

Melanoma is a type of skin cancer, characterized by the uncontrolled growth of pigment-producing cells (melanocytes) in the skin. Surgical resection remains the standard treatment for stage IIB or IIC melanoma, butApproximately one-third of patients with stage IIB melanoma who undergo surgical resection and nearly half of those with stage IIC melanoma experience recurrence within five years of diagnosis.As melanoma progresses to more advanced stages, treatment becomes more challenging and survival rates decline.

Opdivo is a PD-1 immune checkpoint inhibitor designed to harness the body's immune system to fight tumors. It was first approved in 2014 and has since received regulatory approval in more than 65 countries and regions.

CheckMate-76K is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating adjuvant Opdivo therapy (n=526) versus placebo (n=264) in patients with completely resected stage IIB or IIC melanoma. The results showed,At one year, the recurrence-free survival (RFS) rate for Opdivo was 89% (95% CI: 86-92), compared to 79% (95% CI: 74-84) for placebo.In addition, in the pre-specified exploratory subgroup analysis, the HR for RFS was 0.34 (95% CI: 0.20-0.56) for patients with stage IIB melanoma and 0.51 (95% CI: 0.32-0.81) for those with stage IIC melanoma.

References:

[1] U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma. Retrieved October 16, 2023, from https://news.bms.com/news/details/2023/U.S.-Food-and-Drug-Administration-Approves-Opdivonivolumab-as-Adjuvant-Treatment-for-Eligible-Patients-with-Completely-Resected-Stage-IIB-or-Stage-IIC-Melanoma1/default.aspx#:~:text=The%20FDA-approved%20dosing%20for,until%20disease%20recurrence%20or%20unacceptable