Nuvalent Shares Positive Phase 1/2 ALK Inhibitor Data Rivaling Pfizer’s Lorbrena in Lung Cancer
Nuvalent announced positive topline pivotal data for its ALK-selective inhibitor, neladalkib, from the ALKOVE-1 Phase 1/2 trial in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ALK-positive non-small cell lung cancer (NSCLC)175.
Among 253 evaluable TKI pre-treated patients, neladalkib showed a 31% objective response rate (ORR), with higher response rates (46%) noted in specific difficult-to-treat subgroups such as those naïve to lorlatinib, those with the G1202R resistance mutation, and those with CNS involvement5.
The dataset included patients who had received prior therapies including Pfizer’s Lorbrena (lorlatinib), underlining neladalkib’s activity in heavily pretreated populations5.
The ALKOVE-1 trial demonstrated systemic and intracranial efficacy, as well as a tolerable safety profile for neladalkib, which is significant given CNS (brain) metastases are common and challenging in ALK-positive NSCLC54.
Preliminary Phase 2 exploratory data were also presented for TKI-naïve advanced ALK-positive NSCLC patients, with continued follow-up in a separate Phase 3 trial (ALKAZAR) against alectinib, a current standard of care14.
These results position neladalkib as a strong late-stage competitor to Pfizer’s Lorbrena, aiming to address both efficacy and tolerability limitations seen with current ALK inhibitors45.
Based on these pivotal results, Nuvalent plans to discuss a new drug application (NDA) pathway with the FDA, targeting registration in advanced ALK-positive NSCLC51.
Sources:
1. https://www.sec.gov/Archives/edgar/data/0001861560/000119312525283893/d23395d8k.htm
4. https://www.prnewswire.com/news-releases/nuvalent-highlights-recent-pipeline-progress-reiterates-key-anticipated-milestones-and-reports-third-quarter-2025-financial-results-302598795.html
5. https://www.stocktitan.net/sec-filings/NUVL/8-k-nuvalent-inc-reports-material-event-6cb37317b41d.html
7. https://www.morningstar.com/news/pr-newswire/20251117ne25459/nuvalent-announces-positive-topline-pivotal-data-from-alkove-1-clinical-trial-of-neladalkib-for-tki-pre-treated-patients-with-advanced-alk-positive-nsclc