Phase III study evaluating safety and efficacy of adjuvant Opdivo in resected melanoma patients meets primary endpoint

Opdivo demonstrates superior recurrence-free survival versus Yervoy in adjuvant setting in CheckMate -238.

“These topline results support the potential promise of Opdivo as a treatment option for patients with high-risk surgically resected melanoma. There remains an unmet need for additional options as the majority of stage III and resected stage IV high-risk melanoma patients experience disease recurrence after surgery,” said Vicki Goodman, development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “We are committed to researching therapies that may better meet the needs of this patient population and look forward to sharing these data with health authorities soon.”

CheckMate -238 is an ongoing Phase III, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma. The trial randomized 906 patients to receive either Opdivo 3 mg/kg intravenously every 2 weeks or Yervoy 10 mg/kg IV every 3 weeks for four doses and then every 12 weeks until documented disease progression or unacceptable toxicity, up to a maximum treatment duration of one year. The primary endpoint is RFS defined as the time between randomization and the date of first recurrence or death.