Nuvalent reports promising Phase 1 data for zidesamtinib and NVL-655; pivotal data expected 2025

Nuvalent, Inc.

Zidesamtinib ORR 44% in pre-treated ROS1+ NSCLC; 72% in G2032R mutation subset.
NVL-655 at RP2D showed ORR 38% in pre-treated ALK+ NSCLC; 64% in compound mutation patients.
Phase 2 enrollment accelerated: 227 patients in ARROS-1, 229 in ALKOVE-1 as of Sept 1, 2024.
Phase 3 ALKAZAR trial of NVL-655 vs alectinib in TKI-naïve ALK+ NSCLC to start H1 2025; FDA aligned.
Pivotal data from both Phase 2 trials now expected in 2025; no discontinuations due to TRAEs for zidesamtinib.

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