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Reported Saturday, Nuvation Bio Announces Pooled Data From TRUST-I And TRUST-II Studies, Highlighting Taletrectinib's Best-In-Class Potential For Advanced ROS1-Positive NSCLC

Reported Saturday, Nuvation Bio Announces Pooled Data From TRUST-I And TRUST-II Studies, Highlighting Taletrectinib's Best-In-Class Potential For Advanced ROS1-Positive NSCLC

根據週六的報道,Nuvation Bio宣佈了從TRUSt-I和TRUSt-II研究中滙集的數據,突出了Taletrectinib作爲先進ROS1陽性非小細胞肺癌的最佳潛力。
Benzinga ·  09/16 16:51
  • Tumors shrank in 89% of taletrectinib-treated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study
  • Taletrectinib demonstrated durable responses and prolonged progression-free survival (PFS) with long-term follow up; median duration of response (DOR) and median PFS in TKI-naïve patients were 44 months and 46 months, respectively
  • Taletrectinib demonstrated a favorable safety and tolerability profile, including low incidence of neurologic treatment-emergent adverse events (TEAEs) and low rate of treatment discontinuation
  • Nuvation Bio plans to submit a New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2024
  • 愛文思控股ROS1陽性(ROS1+)非小基站-5g肺癌患者中,89%接受他替曲奈膠囊治療的患者腫瘤縮小,其中有56%未曾接受酪氨酸激酶抑制劑(TKI)治療的患者在研究中腫瘤也縮小了
  • 他替曲奈膠囊在長期隨訪中表現出持久的療效和延長的無進展生存期(PFS);TKI-未經治療的患者中,反應持續時間(DOR)的中位數和中位PFS分別爲44個月和46個月
  • 他替曲奈膠囊顯示出良好的安全性和耐受性,包括低發生率的神經系統治療相關不良事件(TEAEs)和低的治療中斷率
  • Nuvation Bio計劃於2024年第四季度向美國食品藥品監督管理局(FDA)提交他替曲奈膠囊的新藥申請(NDA)

譯文內容由第三人軟體翻譯。


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