FDA Approval Insights: Adjuvant Nivolumab in Completely Resected Stage IIB/C Melanoma

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Jeffrey S. Weber, MD, PhD, about the FDA approval of adjuvant nivolumab (Opdivo) for patients with completely resected stage IIB or IIC melanoma. Dr Weber is the deputy director of the New York University (NYU) Perlmutter Cancer Center, as well as a Laura and Isaac Perlmutter Professor of Oncology in the Department of Medicine at the NYU Grossman School of Medicine.

On October 13, 2023, the FDA approved adjuvant nivolumab for adult and pediatric patients aged 12 years and older with completely resected stage IIB or IIC melanoma. This regulatory decision was backed by findings from the phase 3 CheckMate76K trial (NCT04099251), in which patients who received adjuvant nivolumab (n = 526) experienced a 58% reduction in the risk of disease recurrence, new primary melanoma, or death vs those who received placebo (n = 264; HR, 0.42; 95% CI, 0.30-0.59; P < .0001).

In our exclusive interview, Dr Weber discussed the significance of this approval, key efficacy data from CheckMate76K, and potential future directions for PD-1 inhibitor–based combinations in the melanoma treatment paradigm.

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