Nuvalent reports Phase 1 ALKOVE-1 data: NVL-655 shows 39% ORR in heavily pre-treated ALK+ NSCLC

Nuvalent, Inc.

ORR 39% (20/51) in response-evaluable NSCLC patients; 44% (18/41) at ≥50 mg QD dose levels.
Activity in CNS metastases subgroup: ORR 52% (15/29); all responders continued without CNS progression.
Patients with ALK G1202R mutations had 71% ORR (12/17); compound mutations ORR 56% (9/16).
Favorable safety: 2% discontinuations, 5% dose reductions; no TRK-related neurotoxicities; MTD not reached.
100% clearance of ALK resistance mutations in 14/16 patients with G1202R or I1171X mutations by ctDNA.

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