NUVL - Nuvalent stock rises as NVL-520 shows promise in early-stage trial for lung cancer

Nuvalent ( NASDAQ: NUVL ) reported initial data from the phase 1 part of a phase 1/2 trial of NVL-520 to treat patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors.

As of Sept. 1, 35 people have been enrolled in the phase 1 portion of the study, dubbed ARROS-1. Enrollment is still ongoing.

The company said on Friday that treatment with NVL-520 across five evaluated dose levels — ranging from 25 mg once daily (QD) to 125 mg QD — led to exposures above all target efficacy thresholds.

Nuvalent  added that preliminary activity data were available from 21 heavily pre-treated  patients with NSCLC, of which partial responses were seen in 48% (10 out of 21 patients).

Meanwhile, in patients with ROS1 G2032R mutations objective response rate (ORR) was 78% (7 out of 9 patients). In patients with a history of CNS metastases ORR was 73% (8/11).

In patients who had received two or more prior ROS1 TKIs and one or more prior lines of chemotherapy, ORR was 53% (9/17); while for patients previously treated with lorlatinib (sold as Lorbrena by Pfizer) or repotrectinib the ORR was 50% (9/18).

The company noted that as of Sept. 13, no dose-limiting toxicities (DLTs), treatment-related serious adverse events (SAEs), treatment-emergent dizziness or adverse events leading to therapy reductions or discontinuations were seen.

"Importantly, the favorable safety profile and lack of dose reductions or discontinuations due to adverse events reflected in this preliminary data suggest that NVL-520 has the potential to provide deep and durable responses and may be able to move up in the treatment paradigm for patients with ROS1-driven cancers," said Nuvalent Chief Medical Officer Christopher Turner.

NUVL +6.59% to $23.45 premarket Oct. 28

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