(Melanoma) Is Opdivo + Yervoy Effective? — CheckMate 067 Long-Term Follow-Up
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On November 24, 2021, Jedd D. Wolchok et al. from Memorial Sloan Kettering Cancer Center published in the Journal of Clinical Oncology the long-term follow-up efficacy and safety results of the CheckMate 067 Phase 3 clinical trial, evaluating anti-PD-1 antibody Opdivo (nivolumab) + anti-CTLA-4 antibody Yervoy (ipilimumab), Opdivo monotherapy, and Yervoy monotherapy in previously untreated advanced malignant melanoma patients.
The CheckMate 067 Phase 3 trial enrolled previously untreated advanced malignant melanoma patients (N=945) and administered Opdivo + Yervoy (Opdivo 1 mg/kg + Yervoy 3 mg/kg) on a 3-week cycle for 4 cycles. Patients were then randomized 1:1:1 into: Opdivo monotherapy (3 mg/kg, changed to every 2 weeks, N=314), Opdivo + placebo (3 mg/kg, every 2 weeks, N=316), and Yervoy + placebo (3 mg/kg, every 3 weeks, N=315). Primary endpoints were overall survival and progression-free survival; secondary endpoint was objective response rate.
At median follow-up of 6.5 years, the primary endpoint median overall survival was: Opdivo + Yervoy group 72.1 months / Opdivo monotherapy group 36.9 months / Yervoy monotherapy group 19.9 months.
The 6.5-year overall survival rates for patients with BRAF mutation were: Opdivo + Yervoy group 57% / Opdivo monotherapy group 43% / Yervoy monotherapy group 25%. For patients with BRAF wild-type: Opdivo + Yervoy group 46% / Opdivo monotherapy group 42% / Yervoy monotherapy group 22%.
Median progression-free survival was: Opdivo + Yervoy group — not reached / Opdivo monotherapy group 58.7 months / Yervoy monotherapy group 21.9 months.
Based on the long-term follow-up results of the CheckMate 067 trial, Jedd D. Wolchok et al. stated: In previously untreated advanced malignant melanoma, the combination of Opdivo + Yervoy, Opdivo monotherapy, and Yervoy monotherapy all demonstrated favorable antitumor activity over the long term.
Source: https://ascopubs.org/doi/full/10.1200/JCO.21.02229#affiliationsContainer
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