Nuvation Bio announces FDA approval of Ibtrozi for advanced ROS-1+ NSCLC

Nuvation Bio (NUVB) announced that the U.S. FDA has approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer. IBTROZI has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. “The FDA approval of IBTROZI marks a major milestone in the evolution of targeted therapy for advanced ROS1-positive NSCLC,” said David Hung, M.D., Founder, President and CEO of Nuvation Bio. “We believe one of the greatest threats to ROS1-positive lung cancer patients is disease progression, especially in the first-line setting. In pivotal trials, IBTROZI delivered high response rates with sustained durability-truly meaningful benefits for patients. With its clinically proven efficacy and safety profile, we believe IBTROZI has the potential to become a new standard for what targeted therapies can achieve in this type of lung cancer. With approvals for IBTROZI now in the U.S. and China, and additional global filings underway, we remain committed to delivering innovative therapies that help patients stay ahead of their disease.” The FDA approval of IBTROZI is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies. In TRUST-I, IBTROZI achieved a confirmed overall response rate of 90% in TKI-naive patients. These findings were reinforced by the TRUST-II results, with a cORR of 85% in TKI-naive patients. The median duration of response was not yet reached for either trial, based on a cutoff date that is nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the Journal of Clinical Oncology. For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing. For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024. Given the single-arm nature of the TRUST clinical studies, median progression-free survival is not provided in the label.