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Lilly to Showcase Oncology Portfolio Across Tumor Types and Treatment Modalities at the 2026 American Society of Clinical Oncology Annual Meeting
Nuvalent said the studies support recent FDA filings and ongoing trials for its ALK- and ROS1-targeted cancer drugs.
On Friday, May 29, Nuvalent, Inc. will present pivotal neladalkib data and preliminary zidesamtinib results at the American Society of Clinical Oncology Annual Meeting in Chicago.
Nuvalent announced its New Drug Application for neladalkib in April 2026, supported by pivotal data from the global, single-arm ALKOVE-1 Phase 1/2 clinical trial in TKI pre-treated patients with advanced ALK-positive NSCLC.
Neladalkib, an ALK-selective inhibitor, holds breakthrough therapy designation for patients who have received two or more ALK tyrosine kinase inhibitors and is designed for brain penetrance to treat resistant tumors.
Preliminary data from the ARROS-1 trial showed a 40% objective response rate for zidesamtinib in patients with advanced ROS1-positive solid tumors, including those refractory to standard-of-care therapy or prior ROS1 TKI treatment.
Enrollment continues in the global Phase 2 ARROS-1 cohort for adult and adolescent patients as Nuvalent prepares the Phase 3 ALKAZAR trial comparing neladalkib to alectinib in TKI-naïve ALK-positive NSCLC.