Nuvalent reports positive pivotal data for zidesamtinib in ROS1+ NSCLC; NDA submission set for July 2025

Nuvalent, Inc.

Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.
In TKI-naïve cohort, preliminary ORR 89% (31/35) with intracranial ORR 83% (5/6) and 67% complete responses; 104 patients enrolled.
FDA agreed to RTOR for zidesamtinib; rolling NDA to start July 2025, completion targeted Q3 2025, for TKI pre-treated advanced NSCLC.
ALKAZAR Phase 3 trial of neladalkib vs alectinib in ALK+ NSCLC expected to begin enrollment early H2 2025.
Zidesamtinib well tolerated: 2% discontinued due to TEAEs; median exposure 5 months; common TEAEs included peripheral edema (36%).

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