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
根据周六的报道，Nuvation Bio宣布了从TRUSt-I和TRUSt-II研究中汇集的数据，突出了Taletrectinib作为先进ROS1阳性非小细胞肺癌的最佳潜力。
- 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
- 爱文思控股ROS1阳性（ROS1+）非小基站-5g肺癌患者中，89%接受他替曲奈胶囊治疗的患者肿瘤缩小，其中有56%未曾接受酪氨酸激酶抑制剂（TKI）治疗的患者在研究中肿瘤也缩小了
- 他替曲奈胶囊在长期随访中表现出持久的疗效和延长的无进展生存期（PFS）；TKI-未经治疗的患者中，反应持续时间（DOR）的中位数和中位PFS分别为44个月和46个月
- 他替曲奈胶囊显示出良好的安全性和耐受性，包括低发生率的神经系统治疗相关不良事件（TEAEs）和低的治疗中断率
- Nuvation Bio计划于2024年第四季度向美国食品药品监督管理局（FDA）提交他替曲奈胶囊的新药申请（NDA）
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