Pooled Analysis Shows Similar Efficacy of Nivolumab in BRAF V600–Mutant and BRAF Wild-Type Advanced Melanoma

Published by Kevin Ryan · 1 min ·
The point here is the Optivo , Nivolumab. was shown in 4 studies to have up tp to a 35 % response rate lasting an average of 14 months with very tolerable toxicity despite the presence or absence of some known tumor markers. The drug is a PDL-1 inhibitor –This response rate is a breakthrough and supports the checkmate 67 study which uses two antibodies. This one is not too hard to follow. The drug is FDA approved- Dr ryan www.whemtumoristherumorandcanceristheanswer.com/
Pooled Analysis Shows Similar Efficacy of Nivolumab in BRAF V600–Mutant and BRAF Wild-Type Advanced Melanoma STUDY Key Points: •Response rates with nivolumab were similar in patients with and without BRAF mutations. •Response rates did not appear to differ according to prior BRAF inhibitor or ipilimumab therapy or PD-L1 status. A pooled analysis of four clinical trials of nivolumab (Opdivo) in advanced melanoma, reported by Larkin et al in JAMA Oncology, suggested similar response rates in patients with BRAF V600–mutant and BRAF wild-type disease. Study Details The retrospective analysis included data from adult patients with unresectable stage III or stage IV melanoma from four clinical trials. Nivolumab was given at 0.1, 0.3, 1.0, 3.0, or 10.0 mg/kg every 2 weeks until disease progression, treatment discontinuation due to adverse events, withdrawal, or end of study, with 83% of patients receiving the 3 mg/kg dose. Overall, 72% of patients in the BRAF-mutant group had received prior BRAF inhibitor therapy. A total of 73% of patients in the BRAF wild-type group and 86% in the mutant group had received at least two prior therapies for advanced disease. Response Rates Among patients evaluable for objective response, response rates were 34.6% (95% confidence interval [CI] = 28.3%–41.3%) among 217 patients with wild-type BRAF and 29.7% (95% CI = 19.7%–41.5%) among 74 with BRAF-mutant status. Objective response rates did not seem to be affected by prior BRAF inhibitor therapy (35% vs 29% among those with no prior therapy; 30% in BRAF-mutant patients with prior therapy), prior ipilimumab (Yervoy) therapy (36% vs 25% among those with prior therapy; 31% vs 39% among those without prior therapy), or tumor PD-L1 (programmed death ligand 1) status (54% vs 33% among PD-L1–positive patients; 22% vs 27% among PD-L1–negative/indeterminate patients). The median duration of response was 14.8 months (95% CI = 11.1–24.0 months) in the wild-type BRAF group and 11.2 months (95% CI = 7.3–22.9 months) in the BRAF-mutant group, with a median time to response being 2.2 months in both groups. Adverse Events The most common treatment-related adverse events of any grade among the total of 334 wild-type BRAF patients and 106 BRAF-mutant patients were fatigue (26% vs 17%), pruritus (17% vs 9%), rash (12% vs 10%), and diarrhea (12% vs 8%). Treatment-related grade 3 or 4 adverse events occurred in 11.7% vs 2.8%, with none occurring in more than two patients in either group. Adverse events led to discontinuation of treatment in 6% vs 11%, respectively. The investigators concluded, “The results of this retrospective analysis suggest that nivolumab has similar efficacy and safety outcomes in patients with wild-type or mutant BRAF, regardless of prior BRAF inhibitor or ipilimumab treatment VISIT MY WEB SITE www.whentumoristherumorandcanceristheanswer.com/
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