Adjuvant Nivolumab Earns European Approval in Resected Stage IIB/C Melanoma

The FDA accepted a supplemental biologics license application for adjuvant nivolumab in stage IIB or IIC melanoma in February 2023.

The European Commission has approved nivolumab (Opdivo) as an adjuvant treatment for those 12 years and older with completely resected stage IIB or IIC melanoma, according to a press release from Bristol Myers Squibb.¹

Supporting data for the European Commission’s approval came from the double-blind phase 3 CheckMate-76k trial (NCT04099251). After a minimum follow-up of 7.8 months, investigators reported a 58% reduction in the risk of recurrence or death in patients treated with nivolumab compared with those receiving placebo (HR, 0.42; 95% CI, 0.30-0.59; P <.0001). Additionally, nivolumab’s safety profile was comparable with previous reports of the agent. Patients were assigned to receive 480 mg of adjuvant nivolumab once every 4 weeks or matched placebo.

According to previous data that read out at the 2022 Society for Melanoma Research (SMR) Annual Meeting, the 12-month recurrence-free survival (RFS) rate was 89% (95% CI, 86%-92%) for patients receiving nivolumab vs 79% (95% CI, 74%-84%) for those receiving placebo.² The 12-month RFS rates in each respective treatment arm among patients with stage IIB disease were 93% vs 84%, and the corresponding rates for those with stage IIC disease were 84% vs 72%. Additionally, investigators observed RFS benefits following treatment with nivolumab across predefined patient subgroups based on T category and disease stage.

“Patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery,” Peter Mohr, MD, chief physician and head at Skin Cancer Center, Buxtehude, Department of Dermatology, Elbe-Kliniken, Germany, said in the press release.1 “This can be a very impactful event for patients. This approval reinforces the benefit that nivolumab may offer when used after resection, potentially preventing the disease from recurring.”

The FDA accepted a supplemental biologics license application for adjuvant nivolumab in stage IIB or IIC melanoma in February 2023.³ The application for nivolumab in this indication was supported by data from the CheckMate-76k trial.

“The data from the CheckMate-76K trial demonstrate the benefit that [nivolumab] can have for patients with this earlier stage of cancer. We look forward to working with the [FDA]…to potentially offer a treatment option to patients with stage IIB or IIC melanoma that could help prevent recurrence,” Gina Fusaro, PhD, vice president and Development Program lead at Bristol Myers Squibb, said in a press release at the time the FDA accepted the application.³

References

1. Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma. News release. Bristol Myers Squibb. August 22, 2023. Accessed August 24, 2023. https://shorturl.at/azX35
2. 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. News release. Bristol Myers Squibb. October 19, 2022. Accessed August 24, 2023. https://bit.ly/3VKfLMH
3. U.S Food and Drug Administration accepts Bristol Myers Squibb’s supplemental biologics license application and European Medicines Agency validates application for Opdivo (nivolumab). News release. Bristol Myers Squibb. February 28, 2023. Accessed August 24, 2023. bit.ly/3SEJeXk