Key Takeaways
(Bloomberg) -- Nuvalent Inc. plans to present pivotal data for its lung cancer therapy neladalkib and a 40% response rate for its second drug, zidesamtinib, in other solid tumors at the 2026 American Society of Clinical Oncology Annual Meeting.
"The pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC enabled our recent NDA submission to the FDA, and represent important progress toward our goal of offering a new treatment option for this patient population," Christopher Turner, M.D., Chief Medical Officer of Nuvalent, said in a statement.
The data for neladalkib comes from the ALKOVE-1 trial in patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who were previously treated with a tyrosine kinase inhibitor (TKI). For zidesamtinib, the company will present preliminary results from the ARROS-1 trial showing a 40% objective response rate (ORR) among 15 patients with various ROS1-positive solid tumors other than NSCLC.
The presentation of pivotal data that has already supported a New Drug Application (NDA) with the U.S. Food and Drug Administration de-risks the neladalkib program. Meanwhile, the early zidesamtinib data suggests the drug could have potential beyond its initial NSCLC target, a key step toward a broader, more lucrative market.
Nuvalent will present the pivotal results for neladalkib from its ALKOVE-1 study on May 29. The company said the data demonstrated encouraging activity and a well-tolerated safety profile, which prompted its NDA submission to the FDA in April 2026 for TKI pre-treated, advanced ALK-positive NSCLC.
The company is also investigating the drug in treatment-naive patients in its Phase 3 ALKAZAR trial, signaling a strategy to move neladalkib into earlier lines of therapy.
On May 30, Nuvalent will share the first look at zidesamtinib's activity in ROS1-positive cancers outside of its primary indication of NSCLC. In a group of 15 heavily pre-treated patients across 10 different solid tumor types, the drug achieved an ORR of 40%, meaning six patients saw their tumors shrink.
The responses appear durable, with one patient in the trial with an inflammatory myofibroblastic tumor remaining on treatment for approximately 42 months. The company also highlighted responses in patients with metastatic colorectal cancer and cholangiocarcinoma. The data cutoff was September 22, 2025.
The upcoming ASCO presentations could increase investor confidence in Nuvalent's pipeline ahead of a key regulatory decision. The FDA has set a target action date of September 18, 2026, for its decision on zidesamtinib for ROS1-positive NSCLC.
This article is for informational purposes only and does not constitute investment advice.
