BRIEF—Positive Phase III results reinforce potential benefit of Opdivo in earlier stages of melanoma

The Phase III CheckMate -76K trial evaluating Opdivo (nivolumab) in the adjuvant setting in completely resected stage IIB/C melanoma met its primary endpoint and demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival versus placebo at a pre-specified interim analysis.

CheckMate -76K is part of Bristol Myers Squibb's (BMS) development program studying Opdivo and Opdivo-based combinations in earlier stages of cancer, which currently spans seven tumor types.

BMS’ Gina Fusaro, development program lead, melanoma, said: “Stage IIB/C melanoma patients are at high risk of disease recurrence, with approximately one third of stage IIB and half of stage IIC patients experiencing recurrence within five years after surgery.

“The results of the CheckMate -76K study represent a significant advancement for patients with stage IIB/C melanoma and an extension of our legacy in the treatment of melanoma.

“Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal of improving patient outcomes.”