- Nuvalent Inc (NASDAQ: NUVL) announced the initial data from the Phase 1 dose-escalation portion of its ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 in advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors.
- Preliminary activity data reported as of the data cut-off date were available from 21 heavily pre-treated response-evaluable NSCLC patients, of which partial responses were observed in 48% (10/21).
- In patients with ROS1 G2032R mutations, Objective Response Rate (ORR) was 78%.
- Related: Nuvalent Highlights New Data Exhibiting Expanded Preclinical Activity Of NVL-520 In ROS1-Driven Cancers.
- Patients with a history of CNS metastases (ORR 73%, 8/11).
- The most heavily pre-treated of patients receiving two or more prior ROS1 TKIs and one or more prior lines of chemotherapy (ORR 53%, 9/17).
- In patients previously treated with lorlatinib or repotrectinib, ORR was 50%.
- As of the preliminary data cut-off date, 76% (16/21) of response-evaluable patients continued on NVL-520 treatment. Enrollment in the Phase 1 portion of the trial is ongoing.
- Price Action: NUVL shares are up 45.8 at $32.08 on the last check Friday.
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