March 20, 2014
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Nivolumab induced durable remissions in advanced melanoma

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Nivolumab conferred excellent survival outcomes and durable remissions in patients with advanced melanoma, according to results of a multisite study.

Patients treated with nivolumab (BMS-936558, Bristol-Myers Squibb) also showed sustained response after discontinuation of the drug.

The analysis included 107 patients with advanced melanoma, 62% of whom had received multiple prior systemic therapies (range, two to five).

Patients received IV nivolumab — a human IgG4 monoclonal antibody that blocks the inhibitory receptor PD-1 — every week for 96 weeks. Doses ranged from 0.1 mg/kg to 10 mg/kg.

Researchers evaluated OS, long-term safety and duration of response after the conclusion of treatment.

Median OS was 16.8 months. Researchers reported 1-year OS of 62% and 2-year OS of 43%.

Although researchers observed responses at all doses, patients who received a 3 mg/kg dosage demonstrated the highest response rate. Median OS in that group was 20.3 months.

 

F. Stephen Hodi

Thirty-three patients (31%) had objective tumor regressions, and the median response duration was 2 years. Seventeen patients discontinued treatment for reasons other than disease progression. Of those patients, 12 (71%) maintained responses for at least 16 weeks — and as long as 56 weeks — after discontinuation.

“These are striking results for patients with metastatic melanoma,” researcher F. Stephen Hodi, MD, director of the Melanoma Treatment Center at Dana-Farber Cancer Institute, said in a press release. “This study provides the first demonstration of the long-term benefits this treatment approach can produce.”

Disclosure: The researchers report no relevant financial disclosures.