Nuvation Bio presented pooled data from its TRUST‑I and TRUST‑II trials at the American Association for Cancer Research (AACR) 2026 meeting, showing unprecedented durability for its next‑generation ROS1 inhibitor, IBTROZI (taletrectinib). The analysis, which includes patients who had not previously received a ROS1‑targeted therapy, reports a median duration of response of 49.7 months and a median progression‑free survival of 46.1 months.
In the TKI‑naïve cohort, IBTROZI achieved an overall response rate of 89.8 %. Intracranial objective response rates were 76.5 % in patients with brain metastases and 65.6 % in those pretreated with other ROS1 inhibitors. The safety profile remained consistent with earlier reports, with low rates of grade 3 or higher adverse events and no new safety signals identified in the extended follow‑up.
These results reinforce IBTROZI’s position as a durable, CNS‑penetrant therapy for ROS1‑positive non‑small cell lung cancer and support the company’s commercial strategy to capture a larger share of the U.S. market. The data also provide a strong foundation for future regulatory submissions and market expansion plans, underscoring the company’s progress toward its 2026 revenue targets.
"We’re excited to present even longer‑term follow‑up data from our pivotal trials for IBTROZI, which further reinforce the depth and durability of responses in patients with advanced ROS1+ NSCLC across lines of therapy. In particular, with a median duration of response (DOR) now exceeding four years in TKI‑naïve patients, these data continue to highlight IBTROZI’s sustained and clinically meaningful benefit for patients with a manageable safety profile," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "These extensive follow‑up data with this next‑generation ROS1 inhibitor show high rates of responses that last more than four years for many patients, and a median progression‑free survival that's nearly just as long. Critically, the data demonstrated robust intracranial activity without the significant central nervous system toxicities that often limit the long‑term use of other brain‑penetrant therapies," added Lyudmila Bazhenova, M.D., Medical Oncologist at UC San Diego Health.
IBTROZI received FDA approval in June 2025 for adult patients with locally advanced or metastatic ROS1+ NSCLC and is also approved in Japan and China. In Q4 2025, the company reported net product revenue of approximately $15.7 million. Beyond IBTROZI, Nuvation’s pipeline includes safusidenib, an IDH1 inhibitor for glioma, and other programs that position the company for continued growth in the oncology space.
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