Nuvalent to Present Key Data on Neladalkib and Zidesamtinib at ASCO 2026

Event summary

  • Nuvalent will present pivotal data for neladalkib in TKI pre-treated patients with advanced ALK-positive NSCLC from the ALKOVE-1 trial at ASCO 2026.
  • Preliminary data for zidesamtinib in ROS1-positive solid tumors other than NSCLC will also be presented at ASCO 2026.
  • Neladalkib's data supported Nuvalent's recent NDA submission to the FDA for TKI pre-treated advanced ALK-positive NSCLC.
  • Zidesamtinib showed a 40% objective response rate in 15 response-evaluable patients with advanced ROS1-positive solid tumors.
  • Enrollment is ongoing in the global Phase 2 cohort of the ARROS-1 trial for zidesamtinib.

The big picture

Nuvalent's upcoming presentations at ASCO 2026 highlight its strategic focus on developing targeted therapies for cancer patients with limited treatment options. The company's ALK-selective inhibitor neladalkib and ROS1-selective inhibitor zidesamtinib aim to address resistance mutations and brain metastases, potentially offering more durable responses. The data presentations come at a critical juncture as Nuvalent seeks FDA approval for neladalkib and continues to advance zidesamtinib through clinical trials.

What we're watching

Regulatory Timeline
Whether the FDA will approve neladalkib based on the upcoming ASCO data and the recent NDA submission.
Clinical Efficacy
How the preliminary data for zidesamtinib in ROS1-positive solid tumors other than NSCLC will impact its development and potential approval.
Market Differentiation
The pace at which Nuvalent can position neladalkib and zidesamtinib as superior alternatives to existing ALK and ROS1 inhibitors.