Nuvalent Presents Promising Clinical Trial Data

By Bobby Samwell • Monday, September 16 08:13 • Permanent Link

Nuvalent, Inc. (NASDAQ: NUVL), a clinical-stage biopharmaceutical company, has announced the presentation of updated data from the fully enrolled phase 1 dose-escalation portions of the ongoing arros-1 phase 1/2 clinical trial of Zidesamtinib, a novel ROS1-selective inhibitor, and the alkove-1 phase 1/2 clinical trial of NVL-655, a novel ALK-selective inhibitor, at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

The phase 2 portion of the arros-1 trial of Zidesamtinib for TKI-naïve and TKI pre-treated patients with advanced ROS1-positive NSCLC and other solid tumors enrolled 227 patients between September 2023 and September 1, 2024, and the company expects to report pivotal data from this trial in 2025.

For the phase 2 portion of the alkove-1 trial of NVL-655 for TKI-naïve and TKI pre-treated patients with advanced ALK-positive NSCLC and other solid tumors, 229 patients were enrolled between February 2024 and September 1, 2024. The company also expects to report pivotal data from this trial in 2025.

The company plans to initiate the ALKAZAR phase 3 randomized, controlled trial of NVL-655 for treatment-naïve patients with advanced ALK-positive NSCLC in the first half of 2025.

During the phase 1 portion of ARROS-1 from January 2022 to August 2023, 104 patients were enrolled, and data were reported across all doses. Notably, 52% of patients had a history of CNS metastases, and treatment with Zidesamtinib resulted in durable clinical responses across patient subsets. The company expects to report pivotal data from this trial in 2025.

In the phase 1 portion of ALKOVE-1 from June 2022 to February 2024, 133 patients were enrolled, and treatment with NVL-655 resulted in durable clinical responses across patient subsets. The company expects to report pivotal data from this trial in 2025.

The company also plans to initiate the phase 3 randomized, controlled ALKAZAR study with registrational intent for TKI-naïve patients in the first half of 2025.

The primary endpoint for the ALKAZAR trial is progression-free survival (PFS) based on blinded independent central review (BICR), with secondary endpoints including PFS based on the investigator’s assessment, objective response rate (ORR), intracranial ORR, overall survival, and safety.

Nuvalent's CEO, James Porter, expressed optimism about the company's progress and the potential to deliver the programs to patients efficiently.

Today the company's shares have moved 7.1% to a price of $87.45. For more information, read the company's full 8-K submission here.

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