In the news release,
Nuvation Bio Announces IBTROZI® (Taletrectinib) Showed Highly Durable Responses in Longer-Term Follow-up Data from Pivotal Studies Presented at AACR 2026
Analysis of longer-term pooled data from TRUST-I and TRUST-II demonstrated nearly 50 months median duration of response and 46.1 months median progression-free survival in TKI-naïve patients
IBTROZI also demonstrated a high overall response rate in TKI-naïve patients at 89.8%
Long-term pooled data highlighted in oral and poster presentations at AACR, and TRUST-I data simultaneously published in the
IBTROZI demonstrated robust CNS activity, with an intracranial response rate of 76.5% in TKI-naïve patients and 65.6% in TKI-pretreated patients with brain metastases
Preclinical data presented at AACR showed taletrectinib's potential for suppressing TRKB-mediated lung cancer cell migration
"Achieving durable responses is a primary goal in treating ROS1-positive lung cancer. 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," stated
The new pooled analysis presented at AACR demonstrated robust efficacy with IBTROZI for both TKI-naïve and TKI-pretreated patients in TRUST-I and TRUST-II.
- For TKI-naïve patients (n=157): the analysis showed a cORR of 89.8%, a median DOR of 49.7 months, a median PFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). Median OS was not yet reached.
- For TKI-pretreated patients (n=113): the analysis showed a cORR of 55.8%, a median DOR of 16.6 months, a median PFS of 9.7 months and an intracranial response rate of 65.6% in patients with brain metastases (n=32). Median OS was 29.8 months. Notably, 98% of TKI-pretreated patients (111/113) enrolled following progressive disease on entrectinib or crizotinib. The remaining two patients were enrolled following intolerance to a prior TKI.
A pooled safety analysis demonstrated a favorable and manageable safety profile for IBTROZI, consistent with its prescribing information. Adverse events (AEs) of clinical interest (diarrhea, nausea, vomiting and dizziness) were generally low-grade and resolved quickly. Treatment discontinuations due to treatment-emergent AEs (TEAEs) were low (8.5%). No new safety signals were identified with the longer follow-up.
In another poster session at AACR, new preclinical data showed that taletrectinib inhibited the migration of lung cancer cells, suggesting the ability of taletrectinib to reduce the invasive capacity of lung cancer cells based on its tropomyosin receptor kinase B (TRKB) inhibition profile. In mechanistic studies, taletrectinib reduced the expression of key markers associated with the epithelial to mesenchymal transition pathway. The data also suggested that TRKB-sparing agents may not reduce the migration of TRKB expressing lung cancer cells and may lack the potential CNS-protective effects of TRKB inhibition.
"Our objective was to redefine the standard of care for advanced ROS1-positive NSCLC, and we believe IBTROZI is delivering on that promise," said
To review the publications, visit the Publications page of the
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
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
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.
Please see accompanying full Prescribing Information.
About
Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding IBTROZI'S therapeutic potential, IBTROZI's potential to redefine standard of care for advanced ROS1+ NSCLC, and whether TRKB inhibition has CNS-protective effects in lung cancer. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of
Media and Investor Contacts
Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com
Nuvation Bio Media Contact
media@nuvationbio.com
Update: An earlier version of this release had an incorrect link for
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