The European Commission (EC) has granted approval to Bristol Myers Squibb’s Opdivo (nivolumab) as an adjuvant treatment for stage IIB or IIC melanoma patients who have undergone complete resection.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is used as a monotherapy in adults and adolescents aged 12 years and above.
The approval is based on the positive results from the double-blind, randomised Phase III CheckMate -76K trial.
The study compared adjuvant Opdivo 480mg given every four weeks (Q4W) against placebo for up to 12 months in stage IIB or IIC melanoma patients.
Recurrence-free survival was the primary endpoint while secondary endpoints included safety, distant metastases-free survival, overall survival and progression-free survival on next-line therapy.
After 7.8 months of follow-up, Opdivo was found to reduce the risk of recurrence or death by 58% compared to placebo.
Its safety profile was also found to be consistent with previous studies.
Bristol Myers Squibb vice-president and global programme lead Gina Fusaro stated: “With this approval, we can now offer patients in the European Union with stage IIB or IIC resected melanoma an efficacious treatment option that significantly reduced the risk of disease recurrence.
“This approval builds on our long-standing commitment to bring innovative medicines to patients across the cancer spectrum, including in earlier stages of cancer.”
The company also used Opdivo-based combinations, along with Opdivo, to treat earlier-stage cancer patients as part of its development programme that also included CheckMate-76K.
The programme has so far treated more than 35,000 patients.
In addition to stages IIB and IIC, adjuvant Opdivo is approved for treating stages III and IV resected melanoma patients.
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