Positive Pooled Data from Nuvation Bio’s TRUST-I and TRUST-II Studies Highlight Taletrectinib’s Best-in-Class Potential for Patients with Advanced ROS1-positive NSCLC, Supporting Planned New Drug Application Submission in the Fourth Quarter of 2024

Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies evaluating taletrectinib, an investigational next-generation ROS1 TKI. The findings will be highlighted in a poster presentation on September 14, 2024, at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain.

Maurice Perol, M.D., TRUST-II study investigator and Head of Thoracic Oncology at Léon Bérard Cancer Center, commented on the results: “The unmet need for more effective and tolerable treatments for patients with advanced ROS1-positive NSCLC remains critical. The pooled analysis from the TRUST-I and TRUST-II studies reinforces taletrectinib’s potential to offer clinically meaningful advancements in efficacy combined with a favorable safety profile, including reported median duration of response of 44 months and progression-free survival of 46 months in patients who were TKI-naïve.”

“We are excited to present compelling pooled data from the TRUST-I and TRUST-II studies at ESMO, which highlight taletrectinib’s durable response, prolonged disease control, and favorable safety profile. We believe these results position taletrectinib as a potential best-in-class treatment option for people living with advanced ROS1-positive NSCLC,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “These pivotal data will support our planned NDA submission in the fourth quarter of 2024 and, assuming regulatory approval, will enable us to launch taletrectinib in the U.S. in 2025. We are committed to making a positive impact on the lung cancer community and look forward to sharing updates as we continue toward becoming a commercial stage organization.”

Summary of Pivotal Pooled Data

The pooled efficacy and safety data from the TRUST-I and TRUST-II studies presented at ESMO are as of June 7, 2024; both studies remain ongoing. The ESMO data set includes 337 patients with advanced ROS1+ NSCLC who received 600mg of taletrectinib orally once daily in 21-day cycles.

The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, DOR, PFS, and safety.

Significant Tumor Shrinkage and Durability

The pooled efficacy analyses included 160 patients with advanced ROS1+ NSCLC who had not previously been treated with a ROS1 TKI (TKI-naïve) and 113 patients who had previously been treated with crizotinib or entrectinib (TKI-pretreated).