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Nuvalent, Inc. (NASDAQ:NUVL) on Monday reported topline results from its ALKOVE-1 Phase 1/2 trial.
The study evaluated neladalkib in tyrosine kinase inhibitor (TKI)-pretreated patients with advanced ALK-positive non-small cell lung cancer (NSCLC). The company said the recommended Phase 2 dose was set at 150 mg once daily, selected during the Phase 1 dose-escalation stage.
The primary analysis included 253 TKI-pretreated patients, who had undergone a median of three prior lines of therapy; more than half (51%) had previously received chemotherapy. Nuvalent said the results support further clinical development of neladalkib in this heavily pretreated population.
Activity was observed across subsets of TKI pre-treated patients, and the durability of response was assessed as the probability of patients remaining in response for at least 6, 12, and 18 months.
Nuvalent reported a 31% response rate. After six months, 76% of responses were ongoing. The figure fell to 64% after 12 months and 53% after 18 months.
The study was yet to reach the median duration of response (DOR) after 11.3 months of follow-up.
Additionally, the company shared the first report of preliminary data from 44 TKI-naïve patients from the Phase 2 exploratory cohort for TKI-naïve patients with advanced ALK-positive NSCLC from the ALKOVE-1 study.
In this group, Nuvalent reported a preliminary objective response rate of 86% and a 9% complete response rate. Two of the 38 responders had progressed.
Duration of response ranged from 1.7+ to 14.8+ months, with DOR ≥ 6 and 12 months of 91%.
In 9 patients with measurable intracranial lesions, the IC-ORR was 78%, and the intracranial CR rate was 44%. The IC-DOR ranged from 3.1+ to 7.0+ months with no CNS progression among responders.
Global enrollment of TKI-naïve patients is ongoing in ALKAZAR, Nuvalent’s Phase 3 randomized controlled trial of neladalkib versus alectinib.
The company plans to discuss the topline pivotal data for TKI pre-treated ALK-positive NSCLC with the U.S. Food and Drug Administration at a pre-New Drug Application meeting.
Price Action: NUVL stock is up 16.04% at $111.98 at the last check on Monday.
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Posted In: NUVL
