Nuvation Bio’s first approved product is Ibtrozi, a CNS-active ROS1 inhibitor that in pivotal studies showed high rates of treatment response in patients with non-small cell lung cancer.
The FDA approved Nuvation Bio’s oral ROS1 blocker taletrectinib, which will be sold as Ibtrozi. The approval, issued Wednesday, is for the drug’s use in non-small cell lung cancer. Ibtrozi is Nuvation’s first commercial product.
Writing to investors on Wednesday afternoon, Jefferies analysts noted that Ibtrozi’s “broad label” was good for Nuvation, for which “expectations are very low” due to the company’s stock trading near cash. Its closest competitor, Bristol Myers Squibb’s Augtyro, delivered a “lackluster” performance in the fourth quarter of 2024, making only $15 million worldwide.
“We think patience may be needed by investors with several quarters to execute and demonstrate strong launch momentum,” the analysts wrote.
Nuvation’s stock rose 4% in after-hours trading Wednesday.
Ibtrozi’s approval was backed by data from the Phase II TRUST-I and TRUST-II trials, which together account for “one of the largest global clinical trial programs in ROS1+ NSCLC [non-small cell lung cancer] to date,” according to Nuvation’s Wednesday release. Over 300 patients were enrolled across both trials.
Results from TRUST-I showed a confirmed overall response rate (cORR) of 90% in patients with no prior exposure to tyrosine kinase inhibitor (TKI). TRUST-II confirmed these findings with an 85% cORR. Because of the single-arm nature of the TRUST program, progression-free survival isn’t included in Ibtrozi’s label.
The TRUST studies also specifically looked at the benefits of Ibtrozi in patients with brain metastases—which Nuvation on Wednesday called “among the most common and devastating complications” in ROS1-positive NSCLC—and found high rates of treatment response. In patients with measurable brain metastasis at baseline, Ibtrozi demonstrated an intracranial response of 73% in the TKI-naïve subgroup and 63% in those who had previously been exposed to TKI treatments.
As for safety, the TRUST studies found Ibtrozi to be generally well-tolerated. Most toxicities were low-grade and manageable. Side effects on the central nervous system, such as dizziness, were mostly mild or moderate in severity. Roughly 5% of patients had to adjust dosing due to adverse events.
Designed to be taken orally, Ibtrozi is a CNS-active inhibitor of ROS1, a protein that plays a role in several cellular pathways, including differentiation, proliferation and growth. ROS1 is mutated in 1-2% of NSCLC patients and is associated with earlier disease onset.
