(Melanoma) Efficacy of Opdivo + Yervoy? — CheckMate 067 5-Year Follow-Up
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هذه المقالة ملخص لمعلومات طبية دولية وليست نصيحة طبية، ولا يمكن أن تحل محل تشخيص طبيبك المعالج أو خطة العلاج. المعلومات المعروضة مجمّعة من منشورات عامة وبيانات رسمية لكبرى المؤسسات الطبية اليابانية؛ وتختلف ملاءمة ونتائج أي علاج من مريض لآخر ويجب أن يقيّمها طبيب مؤهل لكل حالة على حدة.
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]
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هل تفكر في تلقّي العلاج في اليابان؟ هل تحتاج إلى معلومات ومساعدة؟
نساعدك في تنظيم المعلومات اللازمة للسفر الطبي إلى اليابان، والتواصل مع المؤسسات الطبية اليابانية، وترتيب استشارة رأي ثانٍ.الاستشارة الأولى مجانية؛ سيساعدك المستشار على توضيح الخطوات التالية.
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