New Drug: Relatlimab and Nivolumab for Advanced Melanoma
Study
Double-blind, randomized Phase II-III trial
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Untreated metastatic or unresectable melanoma
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Relatlimab and nivolumab vs nivolumab alone
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Efficacy
mPFS: 10.1 vs 4.6 mos (HR:0.75; P=0.006)
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12 months PFS: 47.7% vs 36.0%
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PD L1<1 mPFS: 6.4 vs 2.9 mos (HR:0.66)
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PD L1>=1 mPFS: 15.7 vs 14.7 mos (HR:0.95)
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Safety
Most AE’s: Hypothyroidism or thyroiditis (in 18.0% of the patients), rash (in 9.3%), diarrhea or colitis (in 6.8%) in combination arm
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Grade >=3 increased levels of lipase (1.7%), ALT (1.4%), AST (1.4%), fatigue (1.1%) in combination arm
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Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022