(Lung Cancer) High Tumor Mutational Burden (TMB) and Its Association with NSCLC Treatment
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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.
High tumor mutational burden (TMB) in non-small cell lung cancer (NSCLC) patients receiving first-line combination Opdivo (nivolumab) and Yervoy (ipilimumab) was associated with a statistically significant improvement in progression-free survival (PFS).
On February 5, 2018, Ono Pharmaceutical announced the Phase III clinical trial results of CheckMate-227 (NCT02477826), which evaluated first-line treatment combining Yervoy and Opdivo in NSCLC patients.
The CheckMate-227 trial enrolled over 2,500 NSCLC patients and was divided into three parts based on PD-L1 positive, PD-L1 negative, and broader patient background data.
For PD-L1-positive patients: the groups were Opdivo monotherapy, Opdivo + Yervoy combination, and chemotherapy; and Opdivo + chemotherapy combination (Part 1a). For PD-L1-negative patients, the same groupings minus Opdivo monotherapy were used (Part 1b).
The data reported this time focused on patients with high TMB regardless of PD-L1 status, comparing biweekly Opdivo 3 mg/kg + every-six-week Yervoy 1 mg/kg with chemotherapy using PFS as the comparative analysis metric.
TMB was assessed using Foundation Medicine's Foundation One CDx. Among the enrolled patients, 45% had tumor mutational burden ≥10 mut/Mb.
The primary endpoint PFS analysis showed that statistically, the combination of the two drugs was proven to extend PFS.
Based on CheckMate-227 data, Dr. Matthew D. Hellmann stated: Through this trial, the total genomic tumor mutation load — tumor mutational burden (TMB) — was demonstrated to be a biomarker that can indicate immunotherapy activity. Regardless of PD-L1 status, when using Opdivo + Yervoy, TMB can serve as a reference indicator.
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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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