Georgina Long, MD, PhD, Melanoma Institute Australia, Sydney, Australia, discusses 3-year follow-up results from the phase 3 CheckMate 76K trial which demonstrated that adjuvant nivolumab continued to sustain clinical benefit among patients with resected stage IIB/IIC melanoma.

Dr Long presented these results at the 2024 European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain.

Transcript: 

My name is Professor Georgina Long from Melanoma Institute Australia in the University of Sydney. I presented the results from the phase 3 CheckMate 76K study.

This was adjuvant nivolumab versus placebo for resected stage IIB and IIC melanoma. All patients had to have had a central node biopsy procedure which was negative. This is the third interim analysis and the 3-year follow-up, and what we found was a consistent and persistent improvement in the relapse-free survival and distant metastasis-free survival. Importantly, the hazard ratio was 0.62, representing a 38% reduction in the risk of a recurrence of nivolumab versus placebo, and for distant metastasis-free survival, for this third interim analysis it was 0.72, so a 28% reduction in the risk of a distant metastasis when patients received nivolumab over placebo. The subgroup analysis showed that both the relapse-free survival and distant metastasis-free survival favored nivolumab for almost every subgroup, particularly for males, those with a nodular subtype of primary melanoma, and those who had primary melanomas on the head and neck or on the arm.

We then looked at a model to predict who did best in terms of a predictive capacity of the model for who benefited the most from nivolumab, and we'd done that before and we'd presented that at ASCO 2023, but this time around we looked at the clinical risk model from Melanoma Institute Australia and divided patients into high, intermediate, and low- risk, and still, nivolumab did better than placebo for the high and intermediate risk patients. For the low risk it wasn't as striking, although there was a trend towards nivolumab improving outcomes, relapse-free survival, for patients. We then delved into that low-risk group and found that those with a high tumor mutation burden and high baseline CD8T cells had the greatest benefit from nivolumab when they were considered low-risk of recurrence.

Source: 

Long GV, Vecchio MD, Hoeller C, et al. Adjuvant nivolumab v placebo in stage IIB/C melanoma: 3-year results from CheckMate 76K. Presented at 2024 ESMO Congress. September 13-17, 2024. Abstract 1077MO