On August 5, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that new data will be presented at the IASLC 2025 World Conference on Lung Cancer (WCLC) taking place September 6–9, 2025 in Barcelona, Spain, and the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress Meeting (ESMO) (Free ESMO Whitepaper) October 17–21, 2025 in Berlin, Germany (Press release, Nuvation Bio, AUG 5, 2025, View Source [SID1234654816]). These data include new results from the pivotal Phase 2 TRUST-I and TRUST-II studies on the efficacy and safety of IBTROZI (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC).
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"We’re proud of the meaningful impact IBTROZI, a highly selective, next-generation oral tyrosine kinase inhibitor, has had on the ROS1+ NSCLC community following its recent FDA approval," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We look forward to presenting new data from our pivotal trials that further reinforce the established efficacy and safety profiles of IBTROZI across multiple patient groups living with ROS1+ NSCLC and that offer additional preclinical and pharmacologic insights. These findings underscore the value IBTROZI brings as an important treatment option for people with this disease."
Presentations Overview:
WCLC
Title: Updated Efficacy and Safety of Taletrectinib in Patients With ROS1+ Non-Small Cell Lung Cancer: The Global TRUST-II Study
Presenter: Geoffrey Liu, M.D., Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto
Session Category: MA02 – New Treatment Strategies in Other Than EGFR-Positive Tumors
Date: Sunday, September 7, 2025
Session Time: 12:00 – 1:15 p.m. CEST
Title: Updated Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: Phase 2 TRUST-I Study
Presenter: Wei Li, M.D., Shanghai East Hospital, Tongji University
Session Category: P3.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Date: Tuesday, September 9, 2025
Session Time: 10:00 – 11:30 a.m. CEST
Title: TRUST-III: Phase 3 Head-to-Head Study of Taletrectinib vs Crizotinib in Patients with ROS1+ Non-Small Cell Lung Cancer
Presenter: Caicun Zhou, M.D., Ph.D., Shanghai East Hospital, Tongji University
Session Category: P3.18 – Clinical Trials in Progress
Date: Tuesday, September 9, 2025
Session Time: 10:00 – 11:30 a.m. CEST
Title: Clinical Pharmacologic Characteristics of Taletrectinib
Presenter: Maurice Perol, M.D., Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France
Session Category: P3.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Date: Tuesday, September 9, 2025
Session Time: 10:00 – 11:30 a.m. CEST
Title: Taletrectinib, a Next Generation Selective ROS1 inhibitor, Exhibits a Differentiated Profile in ROS1 Fusion Models
Presenter: Hitisha Patel, Ph.D., Director of Research, Nuvation Bio
Session Category: P3.12 – Metastatic Non-small Cell Lung Cancer – Targeted Therapy
Date: Tuesday, September 9, 2025
Session Time: 10:00 – 11:30 a.m. CEST
ESMO
Title: TRUST-II Global Study: Efficacy and Safety of Taletrectinib After Prior Entrectinib Exposure in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer
Session Category: Saturday Poster Session
Presenter: Filippo De Braud, M.D., University of Milan, Milan, Italy
Date: Saturday, October 18, 2025
Session Time: 12:00 – 12:45 p.m. CEST
At WCLC, Nuvation Bio will also sponsor a satellite symposium, titled "Under the Microscope: Focusing on ROS1+ NSCLC," on Sunday, September 7 from 1:45 – 2:45 p.m. CEST. Presenters include Charu Aggarwal, M.D., MPH, University of Pennsylvania; Jüergen Wolf, M.D., University Hospital Cologne; and Javier deCastro, M.D., La Paz University Hospital.
The materials will be made available in the Publications section of Nuvation Bio’s website after the presentations. To learn more about Nuvation Bio, visit Booth #201 at WCLC and Booth #4018 at ESMO (Free ESMO Whitepaper).
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 CNS metastases. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.
About IBTROZI
IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer. Learn more at IBTROZI.com.
About the TRUST Clinical Program
The TRUST clinical program evaluating IBTROZI for the treatment of adult patients with advanced ROS1+ NSCLC included two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 164 patients. The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Secondary endpoints include intracranial cORR, duration of response, progression-free survival, and safety.
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 IBTROZITM (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.
Please see accompanying full Prescribing Information.