Nuvalent Shares Hit Record High on Promising Lung Cancer Drug Data
Neladalkib shows a 31% response rate in heavily pre-treated patients, carving out a potential niche in the competitive ALK-positive lung cancer market.
Shares of Nuvalent Inc. (NASDAQ: NUVL) surged more than 15% in Monday trading to a record high, after the biotechnology firm announced positive pivotal trial results for its next-generation lung cancer therapy, neladalkib.
The Cambridge, Massachusetts-based company’s stock climbed to over $111, breaching its 52-week high, as investors reacted to data showing the drug’s effectiveness in patients with advanced non-small cell lung cancer (NSCLC) who have already undergone multiple prior treatments.
Nuvalent reported that in its pivotal ALKOVE-1 trial, neladalkib achieved a 31% objective response rate (ORR) in a group of 253 patients with ALK-positive NSCLC. This patient population was heavily pre-treated, having received a median of three prior tyrosine kinase inhibitors (TKIs), a class of targeted cancer drugs. The results suggest a durable effect, with an estimated 64% of responses lasting at least 12 months.
The drug demonstrated even greater efficacy in a key subgroup of patients who had not previously been treated with Pfizer’s potent third-generation inhibitor, Lorbrena (lorlatinib). In this lorlatinib-naïve group, the response rate jumped to 46%, with an estimated 80% of responses lasting a year or more, according to the company's official announcement.
“Our focus remains on delivering our precisely targeted therapies to patients as quickly as possible,” said James Porter, Ph.D., Chief Executive Officer at Nuvalent, in a statement. “We look forward to discussing these pivotal data with the FDA and aligning on a potential registration path for neladalkib.”
The positive data positions Nuvalent to compete in a market for ALK-positive NSCLC, which accounts for about 5% of all NSCLC cases. The drug is designed to overcome resistance to existing therapies and has shown promise in treating brain metastases, a common and difficult challenge for these patients. The trial data revealed a 32% intracranial response rate in pre-treated patients with measurable brain lesions, climbing to 63% in the lorlatinib-naïve subgroup.
Analysts reacted favorably to the news, viewing the results as a significant de-risking event for the company. Stifel reiterated its 'Buy' rating and raised its price target on Nuvalent to $135 from $115, signaling strong confidence in neladalkib's commercial prospects.
Nuvalent also highlighted the drug’s safety profile, which it described as generally well-tolerated and consistent with its design to be highly selective for the ALK mutation while sparing the TRK family of receptors, which can lead to neurological side effects. The discontinuation rate due to treatment-related adverse events was low at 5%.
With these results in hand, Nuvalent plans to schedule a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration to map out a path toward potential approval. The company’s market capitalization swelled to nearly $7 billion on the back of the news, reflecting investor optimism that neladalkib could become a valuable new tool for oncologists treating this specific form of lung cancer.