FDA approves Opdivo for adjuvant treatment of earlier stage resected melanoma
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The FDA approved nivolumab as adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, according to the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 inhibitor previously approved for several cancer indications, including for adult and pediatric patients 12 years and older with stage III and stage IV completely resected melanoma.
“[Patients with] stage IIB and IIC melanoma may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” Catherine Owen, senior vice president and general manager for U.S. cardiovascular, immunology and oncology at Bristol Myers Squibb, said in a company-issued press release. “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease, and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option, which may help prevent recurrence.”
The FDA approved nivolumab based on results from the double-blind phase 3 CheckMate -76K trial. The study included 790 patients with completely resected stage IIB or IIC melanoma randomly assigned to receive nivolumab dosed at 480 mg IV every 4 weeks for up to 12 months or placebo.
Investigator-assessed RFS served as the study’s primary endpoint. Secondary endpoints included OS, distant metastases-free survival, PFS when receiving next-line therapy and safety.
The study met its primary endpoint, as nivolumab reduced the risk for recurrence, new primary melanoma or death by 58% compared with placebo (HR = 0.42; 95% CI, 0.3-0.59).
Investigators observed a 93% (95% CI, 89–95) RFS rate at 1 year for those with stage IIB disease who received nivolumab vs. 84% (95% CI, 77–89) with placebo. Likewise, those with stage IIC disease had an 84% (95% CI, 78–88) RFS rate at 1 year compared with 72% (95% CI, 62–80) among those who received placebo.
The most frequent adverse reactions (greater than 20%) reported with use of nivolumab in the Checkmate -76K trial included fatigue (36%), musculoskeletal pain (30%), rash (28%), diarrhea (23%) and pruritus (20%). Serious adverse events occurred in 18% of patients, with one treatment-related death noted during the study.
“Following surgical removal of melanoma, patients may believe they are free of disease,” John M. Kirkwood, MD, distinguished professor of medicine at University of Pittsburgh School of Medicine and co-director of the Melanoma Center at UPMC Hillman Cancer Center, said in the release.
“However, within 5 years of diagnosis, one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected IIC melanoma see their cancer return, underscoring the need for additional treatment options that may help reduce the risk for cancer coming back,” he added. “The significant recurrence-free survival improvement observed with nivolumab in CheckMate -76K is an important step forward for these patients.”
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