The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for nivolumab as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma.
The sBLA is supported by data from the phase 3 CheckMate76K trial (ClinicalTrials.gov Identifier: NCT04099251). The trial was designed to evaluate the efficacy and safety of adjuvant nivolumab in patients who had undergone complete resection of stage IIB or IIC melanoma and had no evidence of disease but were at high risk of recurrence.
The trial included in 790 patients who were 12 years of age or older. They were randomly assigned to receive nivolumab or placebo. The primary endpoint was recurrence-free survival (RFS).
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Nivolumab was associated with a 58% reduction in the risk of recurrence or death (hazard ratio, 0.42; 95% CI, 0.30-0.59; P <.0001). The 12-month RFS rate was 89% with nivolumab and 79% with placebo.
Among patients with stage IIB disease, the 12-month RFS rate was 93% with nivolumab and 84% with placebo. Among patients with stage IIC disease, the 12-month RFS rates were 84% and 72%, respectively.
The safety profile of nivolumab was consistent with that seen in previous studies. The incidence of grade 3/4 treatment-related adverse events was higher in the nivolumab arm than in the placebo arm (10% and 2%, respectively).
A Prescription Drug User Fee Act target date of October 13, 2023, has been set for this application.
References
US 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. Accessed February 28, 2023. https://www.businesswire.com/news/home/20230227005793/en/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibb%E2%80%99s-Supplemental-Biologics-License-Application-and-European-Medicines-Agency-Validates-Application-for-Opdivo-nivolumab-%E2%80%A6.
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 February 28, 2023. 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.
This article originally appeared on MPR
