Nuvation Bio Inc., a global oncology company, received U.S. Food and Drug Administration (FDA) approval of Ibtrozi (taletrectinib) to treat adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). 

Ibtrozi is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. 

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.

The TRUST clinical program demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated.

In TRUST-I, Ibtrozi achieved a confirmed overall response rate (cORR) of 90% in TKI-naïve patients. These findings were reinforced by the TRUST-II results, with a cORR of 85% in TKI-naïve patients. 

For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and is ongoing. For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and is ongoing as of October 2024. 

Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label.

Across the pivotal studies, consistent results were also observed among patients who were previously treated with a ROS1 TKI (TKI-pretreated). 

Ibtrozi was generally well-tolerated, with most adverse events being low-grade, transient, and manageable.Nuvation Bio also announced the launch of NuvationConnect, a program designed to support patients prescribed Ibtrozi.

David Hung, M.D., Founder, President, and CEO of Nuvation Bio, commented, “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.”