Nuvalent reports NVL-655 Phase 1 data: 45% ORR in evaluable ALK+ NSCLC patients

Nuvalent, Inc.

57 patients received 15–200 mg once daily; 51% had baseline CNS metastases; 77% post-lorlatinib.
ORR 45% (15/33) in evaluable ALK+ NSCLC; 65% (11/17) in patients with ALK resistance mutations.
41% ORR (12/29) in post-lorlatinib patients, including those with compound resistance mutations.
No MTD identified; most common TRAEs: nausea (12%), transaminase elevation (12%), fatigue (9%).
Updated data to be presented Oct 13 at AACR-NCI-EORTC; company to host conference call that day.

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