Adjuvant nivolumab exhibits activity in stage II melanoma
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Adjuvant nivolumab extended RFS compared with placebo among patients with stage IIB/stage IIC melanoma, according to topline data released by the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb), a PD-1 immune checkpoint inhibitor, is approved in the United States for several oncology indications. These apply to use of the agent by specific patients with melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma and other malignancies.
The randomized phase 3 CheckMate -76K trial included patients with completely resected stage IIB/stage IIC melanoma.
Researchers assigned study participants to adjuvant nivolumab dosed at 480 mg every 4 weeks for up to 12 months or placebo.
RFS served as the primary endpoint. Secondary endpoints included OS, distant metastasis-free survival, PFS on next-line therapy and safety measures.
A prespecified interim analysis showed nivolumab conferred a statistically significant and clinically meaningful RFS benefit, according to a Bristol Myers Squibb-issued press release.
Researchers observed no new safety signals.
Complete results from CheckMate -76K will be presented at a medical conference and shared with regulatory authorities, according to the press release.
“[Patients with stage IIB/stage IIC melanoma] are at high risk [for] disease recurrence, with approximately one-third of stage IIB and half of stage IIC patients experiencing recurrence within 5 years after surgery,” Gina Fusaro, PhD, development program lead for melanoma with Bristol Myers Squibb, said in the release. “The results of the CheckMate -76K study represent a significant advancement for patients with [stage IIB/stage IIC] melanoma. ...
“Recurrence represents a life-altering event for people living with cancer,” Fusaro added. “Treating with Opdivo in earlier stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence — a critical goal of improving patient outcomes.”
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