On May 27, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported 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) (Free ASCO Whitepaper) Annual Meeting 2026.
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"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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) Annual Meeting 2026.
About ROS1+ NSCLC
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.
About IBTROZI
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. Learn more about taletrectinib in the U.S. at IBTROZI.com.
About the TRUST Clinical Program
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.
U.S. Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).
IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)
WARNINGS AND PRECAUTIONS
Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).
Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.
Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).
ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.
QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.
In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.
Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.
Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.
Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).
Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.
Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.
Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.
ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).
The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).
DRUG INTERACTIONS
Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS
Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
(Press release, Nuvation Bio, MAY 27, 2026, View Source [SID1234666117])