Nuvalent Stock Jumps On ESMO Data Presentation, Seeks To Raise $350M Via Equity
Nuvalent Stock Jumps On ESMO Data Presentation, Seeks To Raise $350M Via Equity
The Phase 2 portion of the ALKOVE-1 trial of NVL-655 for TKI-naïve and TKI-pretreated patients with advanced ALK-positive NSCLC and other solid tumors enrolled 229 patients. Pivotal data is expected in 2025.Over the weekend, Nuvalent, Inc. (NASDAQ:NUVL) highlighted the presentation of updated data from Phase 1 dose-escalation portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib and ALKOVE-1 Phase 1/2 trial of NVL-655, at the European Society for Medical Oncology (ESMO) Congress 2024.
上週末，Nuvalent, Inc. (納斯達克:NUVL) 突出了在醫學腫瘤學（ESMO）2024年大會上介紹了正在進行的ARROS-1階段1/2試驗的升劑量部分的更新數據，其中包括zidesamtinib和ALKOVE-1階段1/2試驗的NVL-655。
In total, 227 patients were enrolled in the Phase 2 portion of the ARROS-1 trial of zidesamtinib for TKI-naïve and TKI-pretreated patients with advanced ROS1-positive NSCLC and other solid tumors. The company expects to report pivotal data from this trial in 2025.
總共有227位患者參加了ARROS-1試驗的第2階段，其中包括zidesamtinib用於TKI原發和TKI預處理的ROS1陽性非小細胞肺癌和其他實體瘤患者。公司預計將於2025年報告該試驗的關鍵數據。
- The Phase 1 portion of ARROS-1 enrolled 104 heavily pretreated patients. As of the cut-off date of July 1, 71 pretreated patients with ROS1-positive NSCLC were response-evaluable.
- In the overall patient population, the objective response rate (ORR) was 44%, with a duration of response (DOR) of over six months of 83% and 67% for over 12 months. The median duration of response (mDOR) has yet to be reached.
- In the subset of patients with confirmed ROS1 G2032R resistance mutation, the ORR was 72% (13/18) for repotrectinib-naïve patients.
- IC-ORR was 50% (4/8) in intracranial response-evaluable patients with measurable CNS lesions, of which 7/8 patients had been previously treated with the brain-penetrant TKIs lorlatinib and/or repotrectinib. The mIC-DOR was not reached, with no CNS progression observed among confirmed CNS responders.
- ARROS-1階段1部分招募了104名經過大量預處理的患者。截至7月1日，71名接受過預處理的ROS1陽性非小細胞肺癌患者已進行了反應評估。
- 在整體患者群中，客觀反應率(ORR)爲44%，反應持續時間(DOR)超過六個月的患者佔83%，超過12個月的患者佔67%。反應持續時間的中位數尚未達到。
- 在確認有ROS1 G2032R耐藥突變的患者亞組中，repotrectinib初治患者的ORR達到72％（13/18）。
- 在可評估腦內病變反應的患者中，IC-ORR爲50％（4/8），其中7/8患者之前接受了可穿透血腦屏障的TKI lorlatinib和/或repotrectinib。mIC-DOR尚未達到，並且在確認的腦內病變反應者中未觀察到腦內進展。
Also Read: Challenging Road Ahead for Cancer Drugs, Nuvalent Seeks to Break the Mold.
另請參閱: 癌症藥物面臨嚴峻挑戰，Nuvalent力求打破常規。
The Phase 2 portion of the ALKOVE-1 trial of NVL-655 for TKI-naïve and TKI-pretreated patients with advanced ALK-positive NSCLC and other solid tumors enrolled 229 patients. Pivotal data is expected in 2025.
NVl-655用於TKI原發和TKI預處理的ALK陽性非小細胞肺癌和其他實體瘤患者的ALKOVE-1試驗的第2階段招募了229名患者。關鍵數據預計將於2025年公佈。
- The Phase 1 portion of ALKOVE-1 enrolled 133 patients who received doses ranging from 15 to 200 mg QD, and 150 mg QD was selected as the recommended Phase 2 dose (RP2D).
- In the overall patient population, the ORR was 38% at RP2D and at all doses, with a DOR of over six months of 78% at all doses and 100% at RP2D. The median duration of response (mDOR) has yet to be reached for RP2D and reached 14.4 months for all doses.
- ALKOVE-1研究的Phase 1部分入組了133名接受劑量從15到200 mg QD的患者，選擇150 mg QD作爲推薦的Phase 2劑量（RP2D）。
- 在整體患者群中，RP2D處的ORR爲38%，在所有劑量中，持續反應持續時間（DOR）爲78%；而在RP2D處，DOR爲100%。RP2D的中位持續反應時間（mDOR）尚未達到，所有劑量的mDOR爲14.4個月。
The company says the data in heavily pretreated patients could potentially to translate to deep, durable responses in the front-line setting. The company plans to initiate the Phase 3 ALKAZAR study with registrational intent for TKI-naïve patients in the first half of 2025.
公司表示在前期治療中經歷重度治療的患者的數據有望轉化爲前線環境中深入而持久的反應。該公司計劃在2025年上半年啓動具有TKI未用病人登記意圖的Phase 3 ALKAZAR研究。
On Monday, Nuvalent commenced an underwritten public offering of $350 million.
Nuvalent於週一開始進行3.5億美元的包銷公開發行。
Price Action: NUVL stock is up 22.6% at $107.26 at last check Monday.
NUVL股票在上週一最後一次查詢時上漲了22.6%，達到107.26美元。
Photo via Shutterstock
圖片來自shutterstock。
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譯文內容由第三人軟體翻譯。