Taletrectinib

88% of TRUST-II patients reported improved or stable quality of life at first assessment, with the majority sustaining that benefit throughout treatment Cognitive function scores improved or remained stable throughout the course of treatment with IBTROZI IBTROZI provided rapid relief from burdensome symptoms, including cough and shortness of breath May 27, 2026 -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced new patient-reported outcomes data from the pivotal TRUST-II study of IBTROZI® (taletrectinib) in patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The new data will be presented on Sunday, May 31 at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026. "When considering treatment options for these patients, our primary clinical objective is to delay disease progression while simultaneously alleviating symptom burden and ensuring long-term tolerability," said presenting author, Yasir Elamin, M.D., Associate Professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. "The outcomes from TRUST-II are compelling because we see rapid and durable relief from key symptoms, as well as the preservation of cognitive function. This suggests that we can manage the disease without the neurological impairment commonly seen with other treatments." TRUST-II is a global Phase 2 study evaluating the safety and efficacy of IBTROZI in patients with advanced ROS1+ NSCLC, including both TKI-naïve and TKI-pretreated populations. This analysis evaluated responses from 69 TRUST-II patients (TKI-naïve n=23; TKI-pretreated n=46) in North America and Europe using two validated questionnaires that capture quality-of-life and symptom impact data: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC QLQ-LC13. Findings include the following: Mean changes from baseline improved or remained stable for most domains across both questionnaires. Quality-of-life and cognitive function scores improved from baseline or remained stable over time in both TKI-naïve and TKI-pretreated patients. At the first assessment (day 1 of cycle 2), 88% of patients reported improved or stable global health quality-of-life scores, including 93% of TKI-pretreated patients. The majority of patients in both subgroups improved or remained stable across subsequent time points throughout treatment. At the first assessment, 84-96% of patients reported improved or stable scores for coughing and shortness of breath, with no worsening of cough in TKI-naïve patients, and these improvements were sustained through eight months of treatment. "Having navigated the lung cancer journey as a caregiver and patient advocate, I know the deep impact this disease can have on quality of life," said Danielle Hicks, Chief Patient Officer for GO2 for Lung Cancer. "Patients with ROS1+ NSCLC tend to be younger, often still working, raising children or managing caregiving responsibilities of their own. Watching a loved one endure the daily burden of physical symptoms like a persistent cough or shortness of breath is incredibly difficult, but the fear of neurological side effects is just as profound. For the community we serve, data showing that treatment can potentially rapidly ease those physical symptoms while preserving a patient's mental clarity is deeply encouraging. It means patients can experience relief without sacrificing their daily functioning, which is essential for maintaining their quality of life during treatment." "One of our focuses, and an important measure of success, lies in the patient experience and the ability to maintain or improve their quality of life," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "These TRUST-II findings, which demonstrate stable or improved cognitive function in addition to the robust efficacy results previously reported for IBTROZI, align clinical goals with the needs and perspectives of the patient community." Nuvation Bio announced in June 2025 that the U.S. Food and Drug Administration (FDA) approved IBTROZI for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. In May 2026, the FDA accepted a supplemental New Drug Application (sNDA) with updated data for IBTROZI with a target action date of January 4, 2027. IBTROZI is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON®. Additionally, Nuvation Bio, along with its partner Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency for full approval consideration with a standard review timeline. A separate "Trial in Progress" poster on the TRUST-IV Phase 3 study will also be presented at ASCO on Sunday, May 31. Poster Presentations Overview: Title: Patient-reported outcomes (PROs) and health-related quality of life (HRQoL) with taletrectinib in advanced ROS1+ non-small cell lung cancer (NSCLC) from the TRUST-II study Presenter: Yasir Elamin, M.D., Associate Professor, Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center Date: Sunday, May 31, 2026 Session Time: 9:00 a.m.-12:00 p.m. CDT Poster Board Number: 419 Abstract Number: #8629 Title: Trial in progress: Randomized, double-blind, Phase 3 TRUST-IV study of adjuvant taletrectinib vs placebo in patients with stage IB–IIIA ROS1+ non-small cell lung cancer (NSCLC) Presenter: Alexander Spira, M.D., Ph.D., Medical Oncologist, Virginia Cancer Specialists Date: Sunday, May 31, 2026 Session Time: 9:00 a.m.-12:00 p.m. CDT Poster Board Number: 600b Abstract Number: #TPS8130 The publications will be available on the Publications page of the Nuvation Bio website following their presentation. To learn more about Nuvation Bio, visit Booth #35117 at the ASCO Annual Meeting 2026. Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases. IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naïve and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI ®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. 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