Nuvation Bio, a late-stage global biopharmaceutical company focused on oncology, has announced several updates for its taletrectinib program. Data from the global, pivotal Phase 2 TRUST-II study will be presented orally at the World Conference on Lung Cancer (WCLC) 2024, taking place from September 7-10 in San Diego, California. Additionally, pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies will be presented as a poster at the European Society for Medical Oncology (ESMO) 2024 conference, scheduled for September 13-17 in Barcelona, Spain. This pooled data will support the Company’s New Drug Application (NDA) in the United States.
The U.S. Food and Drug Administration (FDA) has also granted Orphan Drug Designation to taletrectinib for the treatment of multiple non-small cell lung cancer (NSCLC) indications, including ROS1-positive NSCLC. This designation is given to support drug candidates for underserved or rare diseases affecting fewer than 200,000 people in the U.S., and it qualifies taletrectinib for various development incentives, such as tax credits for clinical trials, waiver of application fees, and potential market exclusivity for seven years upon FDA approval.
David Hung, M.D., Founder, President, and CEO of Nuvation Bio, expressed excitement about these developments, stating that the latest data from TRUST-II and the pooled data from TRUST-I and TRUST-II will be shared at the upcoming conferences. He also highlighted the significance of the FDA’s Orphan Drug Designation as a key regulatory milestone, positioning the company to commercialize taletrectinib in 2025.
Taletrectinib is being evaluated for the treatment of patients with ROS1-positive NSCLC in two pivotal Phase 2 studies: TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811), a global study. The Orphan Drug Designation also covers taletrectinib for treating NTRK-positive, ALK-positive, LTK-positive, ACK1-positive, or DDR1-positive NSCLC.
