Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI® (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Cancer

New TRUST-I and TRUST-II subgroup data suggest IBTROZI efficacy is durable and consistent regardless of prior chemotherapy or ROS1 fusion partner.

Rhea-AI Summary

Nuvation Bio (NUVB) reported new subgroup analyses from the TRUST-I and TRUST-II trials of IBTROZI (taletrectinib) in advanced ROS1+ NSCLC.

Pooled TKI-naïve data previously showed a confirmed objective response rate (ORR) of 89.8% and median duration of response (DOR) of 49.7 months. New WCLC 2026 analyses showed ORR of 90.0% in TKI-naïve patients who had prior chemotherapy (n=30) versus 89.8% without prior chemotherapy (n=127), with median DOR of 48.3 and 54.3 months, respectively. Efficacy was similar across ROS1 fusion partners: in TKI-naïve patients, ORR was 89.5% for CD74 fusions and 88.9% for non-CD74, with median DOR of 44.8 and 43.3 months and median PFS of 46.1 and 44.6 months.

With longer follow-up, no new safety signals were seen; common adverse events included liver enzyme elevations, diarrhea, nausea and vomiting.

Positive

• TKI-naïve pooled ORR 89.8% with median DOR 49.7 months
• Prior chemotherapy subgroup ORR 90.0% vs 89.8% without chemo; DOR 48.3 vs 54.3 months
• Fusion-partner subgroups ORR ~89% for both CD74 and non-CD74, with similar DOR and PFS around 44–46 months
• No new safety signals observed with longer-term IBTROZI follow-up
• FDA approval (June 11, 2025) for adult locally advanced or metastatic ROS1+ NSCLC
• Multiple registrational studies ongoing, including Phase 3 TRUST-III and TRUST-IV trials

Negative

• Liver enzyme elevations in 88% (AST) and 85% (ALT) of patients; 0.6% fatal liver events
• ILD/pneumonitis in 2.3% of patients, including 1.1% Grade 3/4 and one fatal case
• QTc prolongation >60 msec in 13% and QTcF >500 msec in 2.6% of patients
• Hyperuricemia reported in 14% of patients, sometimes requiring urate-lowering therapy
• Skeletal fractures in 3.4% of patients, including 1.4% Grade 3 events

Market Context

Before publication, NUVB closed at $5.94; the comparable Aug 4 announcement had a 4.55% 24-hour reac...

Analysis

Before publication, NUVB closed at $5.94; the comparable Aug 4 announcement had a 4.55% 24-hour reaction, providing prior market context for today’s delivered subgroup analyses.

Key Figures

ORR with prior chemotherapy: 90.0% ORR without prior chemotherapy: 89.8% Median DOR with prior chemotherapy: 48.3 months +5 more

ORR with prior chemotherapy

90.0%

TKI-naive patients; n=30

ORR without prior chemotherapy

89.8%

TKI-naive patients; n=127

Median DOR with prior chemotherapy

48.3 months

TKI-naive patients

Median DOR without prior chemotherapy

54.3 months

TKI-naive patients

ORR with CD74 fusion

89.5%

TKI-naive patients; n=19

ORR with non-CD74 fusion

88.9%

TKI-naive patients; n=18

Median DOR by fusion partner

44.8 months and 43.3 months

CD74 and non-CD74 fusions, respectively

Median PFS by fusion partner

46.1 months and 44.6 months

CD74 and non-CD74 fusions, respectively

Historical Context

1 past event · Latest: Aug 04

1 event

1. Aug 04

   IBTROZI subgroup analyses

   24h Move

   +4.5%

   Earlier announcement previewed subgroup analyses of TRUST-I and TRUST-II at WCLC.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

objective response rate, duration of response, progression-free survival, hepatotoxicity, +1 more

5 terms

objective response rate medical

"confirmed objective response rate (ORR) of 89.8%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

duration of response medical

"median duration of response (DOR) of 49.7 months"

Duration of response is the length of time a patient’s condition stays improved after a treatment until it starts to worsen again; think of it as how long a freshly charged battery continues to power a device. For investors, longer duration of response implies a treatment provides sustained benefit, which can boost a drug’s commercial value, support stronger regulatory labeling and payer coverage, and reduce the need for additional therapies.

progression-free survival medical

"median progression-free survival (PFS) at 46.1 and 44.6 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

hepatotoxicity medical

"Hepatotoxicity, including drug-induced liver injury"

Hepatotoxicity is liver damage caused by a drug, chemical or other medical treatment that impairs the liver’s ability to process toxins and support metabolism. For investors it matters because evidence of liver harm during testing or after a product is launched can delay regulatory approval, lead to expensive safety studies or recalls, and cut future sales—like an engine problem that grounds a vehicle and reduces its value.

qtc interval prolongation medical

"QTc Interval Prolongation: QTc interval prolongation can occur"

QTc interval prolongation is a lengthening of the heart’s electrical “reset” time measured on an electrocardiogram after adjusting for heart rate; think of it like a loading bar that takes longer than normal to return to zero. It matters to investors because pronounced prolongation can signal a risk of dangerous irregular heartbeats, trigger regulatory review, clinical-trial changes, safety warnings or market setbacks for drugs and medical devices, and therefore can affect a company’s valuation and timelines.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups

Among patients who received IBTROZI after prior chemotherapy, response rates remained consistent, offering reassurance for patients who begin chemotherapy before a ROS1 fusion is identified

NEW YORK, Sept. 15, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies evaluating IBTROZI^® (taletrectinib) in both TKI- naïve and TKI-pretreated patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The data, presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) in Seoul, Republic of Korea, demonstrated that IBTROZI delivered consistent efficacy regardless of prior chemotherapy exposure or ROS1 fusion partner, providing additional evidence supporting its use across a broad range of patients with advanced ROS1+ NSCLC.

"The most important step for a patient with newly diagnosed non-small cell lung cancer is to conduct comprehensive biomarker testing to identify a targetable driver and start the right targeted therapy as early as possible," said Jorge Nieva, M.D., medical oncologist at USC Norris Comprehensive Cancer Center. "Guidelines recommend holding treatment until biomarker testing comes back, which can create pressure to begin chemotherapy first. These analyses offer reassurance that patients who do start chemotherapy before a ROS1 fusion is identified can still respond well once they transition to taletrectinib. We hope this gives clinicians added confidence to move promptly to targeted therapy as soon as biomarker testing confirms a ROS1 fusion."

"We've already been impressed by the durable efficacy of IBTROZI, with many responses lasting over four years, and now these new data answer critical questions about its consistency," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "These analyses show that patients derive a similar, powerful benefit from IBTROZI across multiple subgroups, which we hope gives clinicians even greater confidence in selecting IBTROZI for any patient with advanced ROS1+ NSCLC."

Previously at AACR 2026, the pooled analysis of all TKI-naïve patients in the TRUST-I and TRUST-II studies presented showed a confirmed objective response rate (ORR) of 89.8% and a median duration of response (DOR) of 49.7 months. At WCLC, one of the new analyses presented in the poster revealed consistent response rates regardless of prior chemotherapy exposure.

Among TKI-naïve patients:

• ORR was 90.0% in those with prior chemotherapy (n=30) and 89.8% in those with no prior chemotherapy (n=127).
• Median DOR was 48.3 months and 54.3 months, respectively.

While this analysis shows that patients can respond to IBTROZI following prior chemotherapy, treatment guidelines continue to recommend waiting to begin treatment until biomarker results come back and initiating targeted therapy as soon as a ROS1 fusion is confirmed. These findings reinforce the importance of early biomarker testing and prompt transition to targeted therapy.

Additionally, both TKI-naïve and TKI-pretreated patients consistently benefited from IBTROZI regardless of ROS1 fusion partner. A fusion partner is the gene that merges with ROS1, resulting in a hybrid, cancer-driving protein that fuels tumor growth. The most common partner is CD74, which accounts for up to half of all ROS1 fusions in NSCLC.

Among TKI-naïve patients:

• ORR was 89.5% in those with CD74 fusions (n=19) and 88.9% in those with non-CD74 fusions (n=18).
• Median DOR was comparable between the two groups at 44.8 and 43.3 months, respectively, as was median progression-free survival (PFS) at 46.1 and 44.6 months.

With long-term follow-up, IBTROZI continued to demonstrate a manageable safety profile consistent with previous reports, with no new safety signals identified. The most common adverse events in the overall TRUST-I and TRUST-II pooled safety analyses were increased AST and ALT, diarrhea, nausea and vomiting, which were mostly low grade.

To review the poster, visit the Publications section of Nuvation Bio's website.

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-naive 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.

Please see accompanying full Prescribing Information.

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. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc). 

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 the clinical objectives when considering treatment options for advanced ROS1+ NSCLC and IBTROZI'S therapeutic potential. 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 Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on August 6, 2026, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Media and Investor Contacts

Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com

Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com

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SOURCE Nuvation Bio Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the new analyses show about IBTROZI use after prior chemotherapy in ROS1+ NSCLC?

Among TKI-naïve patients, objective response rate was 90.0% in those who had received prior chemotherapy (n=30) and 89.8% in those without prior chemotherapy (n=127). Median duration of response was 48.3 months with prior chemotherapy and 54.3 months without, suggesting responses remained consistent even when IBTROZI was started after chemotherapy.

How did IBTROZI perform across different ROS1 fusion partners in TKI-naïve patients?

In TKI-naïve patients with CD74 fusions, ORR was 89.5% (n=19) versus 88.9% (n=18) in those with non-CD74 fusions. Median DOR was 44.8 vs 43.3 months, and median PFS was 46.1 vs 44.6 months, indicating comparable efficacy regardless of fusion partner.

What is the current approved indication for IBTROZI in the United States?

IBTROZI is indicated in the U.S. for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

What are the key ongoing TRUST studies of IBTROZI beyond TRUST-I and TRUST-II?

TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled adjuvant study in resected early-stage ROS1+ NSCLC, planned to enroll about 180 patients globally, with primary endpoint disease-free survival and estimated primary completion in 2030. TRUST-III (NCT06564324) is a confirmatory randomized Phase 3 study comparing IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who are ROS1 TKI-naïve.

What serious safety risks are highlighted in the IBTROZI prescribing information?

Warnings include hepatotoxicity (with drug-induced liver injury and rare fatal events), ILD/pneumonitis (including severe and fatal cases), QTc interval prolongation, hyperuricemia, myalgia with CPK elevation, skeletal fractures, and embryo-fetal toxicity. The company advises liver monitoring, ECG monitoring, and avoidance of strong or moderate CYP3A inhibitors, CYP3A inducers, QT-prolonging drugs, and certain gastric acid–reducing agents where possible.

What common adverse reactions were seen in patients treated with IBTROZI?

The most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). Common Grade 3/4 laboratory abnormalities (≥5%) included increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).