(Lung Cancer) Is Next-Generation ALK Inhibitor Ensartinib Effective?
Medical Supporter — Мэдээллийн мэдэгдэл
Энэ нийтлэл нь олон улсын эмнэлгийн мэдээллийн эмхэтгэл бөгөөд эмнэлгийн зөвлөгөө биш; таны эмчийн оношлогоо, эмчилгээний төлөвлөгөөг орлохгүй. Энд буй мэдээлэл нь Японы томоохон эмнэлгийн байгууллагуудын нээлттэй эх сурвалжаас эмхэтгэсэн бөгөөд аливаа эмчилгээний тохиромж, үр дүн өвчтөн бүрээр өөр тул мэргэшсэн эмч тус бүрчлэн үнэлэх ёстой.
- January 1, 2020
- Reading time: 2 minutes
On October 15, 2019, Yunpeng Yang published results in The Lancet Respiratory Medicine from a Phase II clinical trial evaluating ensartinib monotherapy in ALK-positive non-small cell lung cancer (NSCLC) patients with crizotinib resistance, assessing its efficacy and safety.
This Phase II trial was a single-arm, open-label study conducted in ALK-positive NSCLC patients with crizotinib resistance (N=160). Patients received ensartinib 225 mg once daily. The primary endpoint was objective response rate (ORR); secondary endpoints included safety. Of the 160 patients, 62% (N=97) had brain metastases at baseline.
Results:
Among evaluable patients, the primary endpoint ORR was 52%. Among evaluable patients with brain metastases, the ORR was 70%.
Safety:
At least one adverse event was reported in 91% of patients (145/160). The most common adverse events were skin disorders (56%, N=89), ALT elevation (46%, N=74), and AST elevation (41%, N=65).
Based on the Phase II clinical trial results, Yunpeng Yang concluded that ensartinib monotherapy demonstrated favorable antitumor activity in crizotinib-resistant, ALK-positive NSCLC patients, including those with brain metastases. Further clinical trials are warranted to confirm its utility.
Source: Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial (Lancet Respir Med. 2019 Oct 15. pii: S2213-2600(19)30252-8. doi: 10.1016/S2213-2600(19)30252-8.)
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Японд эмчлүүлэхээр төлөвлөж байна уу? Мэдээлэл, тусламж хэрэгтэй юу?
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