Nuvalent reports positive pivotal data for neladalkib in ALK+ NSCLC; ORR 31% in TKI pre-treated, 46% in lorlatinib-naïve

Nuvalent, Inc.

Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.
In lorlatinib-naïve subset (n=63), ORR 46% (29/63); DOR ≥12 months 80%. Intracranial ORR 63% with 21% CR.
Preliminary TKI-naïve cohort (n=44): ORR 86% (38/44), CR 9%, intracranial ORR 78% with 44% CR.
Safety consistent with ALK-selective design; most common TEAEs: ALT/AST elevations, constipation, dysgeusia. 5% discontinuation.
Company plans pre-NDA meeting with FDA for TKI pre-treated population; detailed results at future medical meeting.

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