Nuvalent stock falls after pivotal lung cancer drug data release

Investing.com -- Nuvalent Inc (NASDAQ:NUVL) stock fell 3.6% in Monday premarket trading after the clinical-stage biopharmaceutical company released topline pivotal data for its investigational ALK-selective inhibitor neladalkib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

The company announced that neladalkib demonstrated a 31% objective response rate in patients previously treated with tyrosine kinase inhibitors (TKIs), with 76% of responders maintaining their response for at least six months. In a subset of patients who were lorlatinib-naïve, the response rate was higher at 46%.

Nuvalent also shared preliminary data from an exploratory cohort of TKI-naïve patients, showing an 86% response rate with durability of response at 12 months estimated at 91%.

The drug demonstrated what the company described as a "generally well-tolerated safety profile." Among 656 patients treated at the recommended Phase 2 dose, the most frequent adverse events included increased liver enzymes (47%), constipation (28%), and taste disturbance (23%). Dose reductions due to adverse events occurred in 17% of patients, while 5% discontinued treatment.

The ALKOVE-1 Phase 1/2 clinical trial enrolled 781 patients with ALK-positive solid tumors, including 656 with advanced ALK-positive NSCLC who received the drug at the recommended Phase 2 dose of 150 mg once daily.

Nuvalent plans to discuss the data with the FDA at a pre-New Drug Application meeting and present detailed results at a future medical conference. The company is also conducting ALKAZAR, a Phase 3 randomized controlled trial comparing neladalkib to alectinib in TKI-naïve patients.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.