Adjuvant Opdivo Meets Primary Endpoint in Phase 3 Study of Resected High-Risk Melanoma Patients

Bristol-Myers Squibb Company announced that a Phase 3 study evaluating Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint at a planned interim analysis, demonstrating superior recurrence-free survival (RFS) in patients receiving Opdivo compared to Yervoy.

“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, M.D., 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.”

These data will be submitted for presentation at an upcoming medical conference.

About CheckMate -238

CheckMate -238 is an ongoing Phase 3, 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 two 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.