Nuvalent (NUVL) 7th Annual Oncology Innovation Summit: Insights for ASCO & EHA summary

Key value drivers and strategic milestones

• Two potential U.S. commercial launches anticipated later this year for ALK and ROS1 programs, with NDA for neladalkib accepted for priority review and a PDUFA date set for November 27, 2026.

• Ongoing launch readiness for zidesamtinib in TKI-pretreated ROS1, with additional data submission planned for TKI-naive ROS1.

• Progressing ALKAZAR phase III trial for TKI-naive ALK and HEROEX-1 phase I-A/I-B for HER2-altered NSCLC, with a new development candidate to be disclosed by year-end.

Clinical data highlights and differentiation

• ALKOVE-1 study enrolled 781 patients, far exceeding original plans, reflecting strong enthusiasm for neladalkib's differentiated profile.

• Neladalkib demonstrated a median duration of response of 17.6 months in third-line ALK setting, more than double that of lorlatinib, with strong CNS activity and broad ALK mutation coverage.

• Early first-line data for neladalkib showed excellent response rates and high intracranial activity, with ongoing phase III trial comparing it to alectinib.

Regulatory and commercial outlook

• NDA for neladalkib targets previously treated ALK patients, aiming to address both second- and third-line settings, leveraging breakthrough designation.

• ROS1 program includes separate NDA submissions for previously treated and TKI-naive cohorts, with a PDUFA date of September 18 for the former and plans to submit naive data this year.

• Launch strategy focuses on building leadership in ALK and ROS1, with initial launches in previously treated populations to establish physician experience.