(Melanoma) Efficacy of Opdivo + Yervoy? — CheckMate 067 5-Year Follow-Up
Medical Supporter — Information Notice
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.
At the European Society for Medical Oncology (ESMO) Annual Meeting held in Barcelona, Spain from September 27 to October 1, 2019, James Larkin presented 5-year follow-up efficacy and safety results from the CheckMate 067 Phase III clinical trial evaluating nivolumab (Opdivo, anti-PD-1) plus ipilimumab (Yervoy, anti-CTLA-4) combination therapy, nivolumab monotherapy, and ipilimumab monotherapy in previously untreated malignant melanoma patients.
The CheckMate 067 Phase III trial enrolled previously untreated Stage III/IV malignant melanoma patients. Primary endpoints were overall survival (OS) and progression-free survival (PFS). Treatment arms:
- Opdivo + Yervoy arm: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for 4 cycles, followed by nivolumab 3 mg/kg every 2 weeks (N=314)
- Opdivo arm: Nivolumab 3 mg/kg every 2 weeks (N=316)
- Yervoy arm: Ipilimumab 3 mg/kg every 3 weeks
Results at median follow-up of 60 months:
Overall Survival (Primary Endpoint): Median OS: Opdivo + Yervoy arm not reached / Opdivo arm 36.9 months / Yervoy arm 19.9 months. 5-year OS rate: Opdivo + Yervoy 52% / Opdivo 44% / Yervoy 26%.
OS improvement by BRAF mutation: Opdivo + Yervoy 60% / Opdivo 30% / Yervoy 48%, demonstrating that the OS improvement with the combination was independent of BRAF mutation status.
5-year OS rate by PD-L1 ≥5%: Opdivo + Yervoy 57% / Opdivo 51% / Yervoy 33%. By PD-L1 <5%: Opdivo + Yervoy 51% / Opdivo 43% / Yervoy 24%.
Progression-Free Survival (Primary Endpoint): Median PFS: Opdivo + Yervoy 11.5 months / Opdivo 6.9 months / Yervoy 2.9 months. 5-year PFS rate: Opdivo + Yervoy 36% / Opdivo 29% / Yervoy 8%.
Based on the CheckMate 067 trial results, James Larkin concluded that nivolumab plus ipilimumab combination therapy demonstrated long-term OS superiority compared to ipilimumab monotherapy in previously untreated malignant melanoma patients.
Source: Nivolumab Combined with Ipilimumab or Alone Outperforms Ipilimumab at 5 Years in Advanced Melanoma [ESMO 2019 Oncology News]
Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).
Considering medical care in Japan? Need information and support?
We help you organize the information needed for medical travel to Japan, liaise with Japanese medical institutions, and arrange a second-opinion consultation.The first consultation is free; an advisor will help you clarify the next steps.
Figure 1
Figure 2
Figure 3
Figure 4