Nuvalent Reports 31% Response Rate In Patients With Advanced Form Of Lung Cancer

Core Insights - Nuvalent, Inc. reported topline results from its ALKOVE-1 Phase 1/2 trial evaluating neladalkib in TKI-pretreated patients with advanced ALK-positive NSCLC, establishing a recommended Phase 2 dose of 150 mg once daily [1][2] Group 1: Trial Results - The primary analysis included 253 TKI-pretreated patients, with a median of three prior therapy lines; 51% had received chemotherapy [2] - A 31% response rate was observed, with 76% of responses ongoing after six months, decreasing to 64% after 12 months and 53% after 18 months [3] - The study has not yet reached the median duration of response after 11.3 months of follow-up [4] Group 2: TKI-Naïve Patients - Preliminary data from 44 TKI-naïve patients showed an objective response rate of 86% and a complete response rate of 9%, with two of the 38 responders having progressed [4] - Duration of response for TKI-naïve patients ranged from 1.7+ to 14.8+ months, with 91% having a DOR of at least 6 and 12 months [5] - In patients with measurable intracranial lesions, the intracranial objective response rate was 78%, and the intracranial complete response rate was 44% [5] Group 3: Future Plans and Market Reaction - The company plans to discuss the topline pivotal data with the U.S. FDA at a pre-New Drug Application meeting [6] - Following the announcement, NUVL stock increased by 16.04% to $111.98 [6]