Bristol Myers Squibb gets positive CHMP opinion recommending nod for Opdivo for adjuvant treatment for Melanoma

“Many patients with stage IIB or stage IIC melanoma face the difficult reality of disease recurrence within five years of surgery,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “In the data from the CheckMate -76K trial, Opdivo was shown to significantly reduce the risk of disease recurrence for these patients. The CHMP’s recommendation brings us closer to potentially providing Opdivo for use in treating additional earlier stages of melanoma in the adjuvant setting, addressing an unmet need for patients in the EU.”

The positive opinion is based upon safety and efficacy results from the Phase 3 CheckMate -76K trial, in which, with a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001).The safety profile of Opdivo was consistent with previously reported studies.

Results from CheckMate -76K were presented as late-breaking data at the 2022 Society for Melanoma Research (SMR) Annual Meeting.

CheckMate -76K is part of Bristol Myers Squibb’s development program which explores the use of Opdivo and Opdivo-based combinations in earlier stages of cancer.

* In 2018 , based upon data from the CheckMate –238 trial, Opdivo was approved by the European Commission for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.