Nivolumab Approved as Adjuvant Treatment for Patients With Completely Resected Stage IIB or Stage IIC Melanoma

The US Food and Drug Administration (FDA) recently announced approval of Opdivo (nivolumab) as an adjuvant treatment for eligible patients with stage IIB or IIC completely resected melanoma.¹ This approval expands upon the existing adjuvant indication for nivolumab in stage III or IV completely resected disease.

The approval was granted following the randomized Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).² Seven hundred and ninety patients aged 12 years and older with a negative sentinel lymph node biopsy, an Eastern Cooperative Oncology Group performance status of 0 or 1, previously untreated for melanoma, and histologically confirmed for resected stage IIB/C cutaneous melanoma participated in the study. The aim of the trial was to determine the effectiveness of nivolumab adjuvant immunotherapy vs placebo in adults and pediatric participants after complete resection of stage IIB/C melanoma with no evidence of disease and without a high risk of recurrence.

Results of the trial showed that nivolumab reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo.² At 1 year, the recurrence-free survival (RFS) rate was 89% for nivolumab vs 79% for placebo.³ In a prespecified, exploratory subgroup analysis, the RFS unstratified hazard ratio was 0.34 in patients with stage IIB melanoma, and 0.51 in stage IIC melanoma. Additionally, 1-year RFS rates by stage for patients who received nivolumab were 93% in stage IIB vs 84% with placebo, and 84% in stage IIC vs 72% with placebo.³

Warnings and precautions for nivolumab include severe and fatal immune-mediated adverse reactions, such as pneumonitis, colitis, hepatitis, hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, and other immune-mediated adverse reactions. Additionally, there are black box warnings for infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, embryo-fetal toxicity, and increased mortality in patients with multiple myeloma when nivolumab is added to a thalidomide analogue and dexamethasone.

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. Press release. Bristol Myers Squibb. October 13, 2023. Accessed October 18, 2023. https://news.bms.com/news/corporate-financial/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

2. Weber JS, Poretta T, Stwalley BD, et al. Nivolumab versus placebo as adjuvant therapy for resected stage III melanoma: a propensity weighted indirect treatment comparison and number needed to treat analysis for recurrence-free survival and overall survival. Cancer Immunol Immunother. 2023;72(4):945-954. doi:10.1007/s00262-022-03302-5

3. Adjuvant therapy with nivolumab versus placebo in patients with resected stage IIB/C melanoma (CheckMate 76K). News release presented at: Society for Melanoma Research 2022 International Congress; October 17–20, 2022; Edinburgh, Scotland.