Nuvation Bio的Ibtrozi获FDA批准用于ROS1阳性肺癌-动脉网

Nuvation Bio's Ibtrozi For ROS1-Positive Lung Cancer Wins FDA Approval

benzinga 等信源发布 2025-06-11 14:31

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The U.S. Food and Drug Administration (FDA) on Wednesday approved

美国食品药品监督管理局 (FDA) 于周三批准

Nuvation Bio Inc.’s

努瓦森生物公司

NUVB

Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive (ROS1+)

伊布妥昔（taletrectinib）用于治疗局部晚期或转移性ROS1阳性（ROS1+）的成年患者

non-small cell lung cancer (NSCLC)

非小细胞肺癌 (NSCLC)

。

The FDA approval of Ibtrozi is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies.

Ibtrozi 的 FDA 批准得到了迄今为止 ROS1+ NSCLC 领域规模最大的全球临床试验项目之一的支持，其中关键的 TRUST-I 和 TRUST-II 研究共招募了 300 多名患者。

In the TRUST-I trial, Ibtrozi achieved a confirmed overall response rate (cORR) of 90% in TKI-naïve (untreated) patients.

在TRUST-I试验中，Ibtrozi在TKI初治（未经治疗）患者中达到了90%的确认总体缓解率（cORR）。

Also Read:

另请阅读：

Small-Cap Cancer-Focused Nuvation Bio Pulls Plug On Early-Stage Program After Considering Phase 1 Solid Tumor Data

小型癌症生物技术公司Nuvation Bio在评估一期实体瘤数据后，终止了早期项目。

TRUST-II trial showed a cORR of 85% in

TRUST-II 试验显示 cORR 为 85%

TKI-naïve patients

TKI初治患者

。

The median duration of response (DOR) was not yet reached for either trial, based on a cutoff date nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the

基于一个比四月份发布的TRUST-I 和 TRUST-II 联合分析数据截止日期还要晚近五个月的截止日期，两项试验的中位缓解持续时间（DOR）均未达到。

Journal of Clinical Oncology

临床肿瘤学杂志

。

For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing.

对于TRUST-I，反应的中位随访时间为40个月，观察到最长的DOR为46.9个月且仍在持续。

For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024.

对于TRUST-II，随访反应的中位时间为19个月，截至2024年10月，观察到最长的DOR为30.4个月且仍在持续。

Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label.

鉴于TRUST临床研究的单臂性质，标签中未提供中位无进展生存期（PFS）。

Across the pivotal studies, consistent results were also observed among patients previously treated with a ROS1 TKI (TKI-pretreated).

在关键研究中，既往接受过ROS1 TKI治疗的患者（TKI预处理）中也观察到一致的结果。

In TRUST-I, treatment with Ibtrozi achieved a cORR of 52% and a median DOR of 13.2 months for TKI-pretreated patients, with a median follow-up for responses of 33 months.

在TRUST-I中，对于经TKI预处理的患者，使用Ibtrozi治疗达到了52%的cORR和13.2个月的中位DOR，反应的中位随访时间为33个月。

In TRUST-II, treatment with Ibtrozi achieved a cORR of 62%. As of October 2024, the median DOR was 19.4 months in these patients, with a median follow-up for responses of 19 months.

在TRUST-II中，使用Ibtrozi治疗的cORR达到了62%。截至2024年10月，这些患者的中位DOR为19.4个月，对反应的中位随访时间为19个月。

An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24).

73%的TKI初治患者（11/15）和63%的TKI预治疗患者（15/24）达到了颅内反应。

Price Action:

价格行为：

NUVB stock is trading lower by 16.8% to $2.105 at last check Wednesday.

NUVB股票在周三最后一次交易中下跌了16.8%，至2.105美元。

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