Nuvalent reports preliminary Phase 1 data for NVL-520: 48% ORR in heavily pre-treated ROS1+ NSCLC

Nuvalent, Inc.

48% ORR (10/21) in heavily pre-treated ROS1+ NSCLC; 78% (7/9) in G2032R mutation patients.
Intracranial PRs in 100% (3/3) with measurable CNS mets; 73% (8/11) with CNS history.
No DLTs, treatment-related SAEs, dizziness, or AEs leading to dose reduction/discontinuation in 35 patients.
Dose levels 25-125 mg QD achieved exposures above target thresholds; half-life supports once-daily dosing.
Phase 1 enrollment ongoing; 76% (16/21) of response-evaluable patients continue treatment.

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