The 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 pivotal randomized, double-blind phase 3 CheckMate -76K trial (ClinicalTrials.gov Identifier: NCT04099251) that evaluated the efficacy and safety of nivolumab as monotherapy in the adjuvant setting in 790 patients 12 years of age and older after complete resection of stage IIB or IIC melanoma with no evidence of disease who are at high risk for recurrence. Patients were randomly assigned to receive nivolumab or placebo. The primary endpoint was recurrence-free survival (RFS).
Results showed that treatment with nivolumab achieved a statistically significant and clinically meaningful reduction in the risk of recurrence or death by 58% vs placebo (hazard ratio, 0.42; 95% CI, 0.30-0.59; P <.0001). The 12-month RFS rates for nivolumab were 89% (95% CI, 86-92) vs 79% (95% CI, 74-84) for placebo. The 12-month RFS rates for patients with stage IIB were 93% for nivolumab vs 84% for placebo; and the 12-month RFS rates for patients with stage IIC were 84% for nivolumab vs 72% for placebo.
The safety profile of nivolumab was consistent with that seen in previous studies. There were no new safety signals observed. The incidence of Grade 3/4 treatment-related adverse events were higher in the nivolumab arm vs the placebo arm (10% vs 2%, respectively).
A Prescription Drug User Fee Act target date of October 13, 2023 has been set for this application.
“The data from the CheckMate -76K trial demonstrate the benefit that Opdivo can have for patients with this earlier stage of cancer. We look forward to working with the US Food and Drug Administration and the European Medicines Agency to potentially offer a treatment option to patients with stage IIB or IIC melanoma that could help prevent recurrence,” said Gina Fusaro, PhD, vice president, development program lead, Bristol Myers Squibb.
Nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, is currently marketed under the trade name Opdivo and is currently approved for various cancers, including as a single agent or in combination with ipilimumab for the treatment of unresectable or metastatic melanoma. It is also approved as adjuvant treatment for melanoma in patients with involvement of lymph nodes or metastatic disease who have undergone complete resection.
- 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.