Adjuvant nivolumab shows activity in stage II melanoma

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September 18, 2022

1 minute read


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The adjuvant nivolumab prolonged RFS compared to placebo in patients with stage IIB/stage IIC melanoma, according to primary data published by the agent 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 the use of the agent by specific patients with melanoma, non-small cell lung cancer, renal cell carcinoma, classic Hodgkin’s lymphoma and other malignancies.

picture of melanoma/skin cancer

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The Phase 3 randomized CheckMate -76K trial enrolled patients with completely resected stage IIB/stage IIC melanoma.

Researchers assigned study participants to adjuvant nivolumab 480 mg every 4 weeks for up to 12 months or to placebo.

RFS served as the primary endpoint. Secondary endpoints included OS, distant metastasis-free survival, PFS on first-line treatment, and safety measures.

A pre-specified interim analysis showed that nivolumab conferred a statistically significant and clinically significant RFS benefit, according to a press release issued by Bristol Myers Squibb.

The researchers observed no new safety signals.

Full CheckMate -76K results 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 patients and half of stage IIC patients experiencing recurrence within 5 years of surgery,” Gina Fusaro, PhD, development program manager for melanoma with Bristol Myers Squibb, said in the statement. “The results of the CheckMate -76K study represent a significant advance for patients with [stage IIB/stage IIC] melanoma. …

“Recurrence represents a life-changing event for people with cancer,” Fusaro added. “Treatment with Opdivo in the early stages of cancer, when the immune system may be more responsive, has the potential to help prevent recurrence – a critical goal for improving patient outcomes.”

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