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.

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.

• 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.

Also Read: Challenging Road Ahead for Cancer Drugs, Nuvalent Seeks to Break the Mold.

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.

• 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.

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.

On Monday, Nuvalent commenced an underwritten public offering of $350 million.

Price Action: NUVL stock is up 22.6% at $107.26 at last check Monday.

Photo via Shutterstock

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