Nuvation Bio to Present New Quality-of-Life Data for IBTROZI® (Taletrectinib) in Patients with ROS1-Positive Non-Small Cell Lung Cancer at ASCO 2026 Annual Meeting

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) reported new patient-reported outcomes from the Phase 2 TRUST-II study of IBTROZI (taletrectinib) in advanced ROS1-positive NSCLC. Among 69 patients, 88% showed improved or stable global quality-of-life at first assessment, with cognitive function and key symptoms like cough and shortness of breath generally improving or remaining stable over time.

IBTROZI is FDA-approved in the US for locally advanced or metastatic ROS1+ NSCLC, approved in Japan and China, has a US sNDA under review with a target action date of January 4, 2027, and an EMA MAA validated in Europe. Results will be presented at ASCO 2026.

Positive

• 88% of TRUST-II patients had improved or stable global quality-of-life at first assessment
• 93% of TKI-pretreated patients reported improved or stable global quality-of-life at first assessment
• 84–96% of patients had improved or stable coughing and shortness-of-breath scores through eight months
• Cognitive function scores improved or remained stable across treatment in both TKI-naïve and pretreated groups
• IBTROZI already FDA-approved in US for locally advanced or metastatic ROS1+ NSCLC
• FDA accepted IBTROZI sNDA with January 4, 2027 target action date
• IBTROZI approved in Japan and China, expanding ROS1+ NSCLC commercial footprint
• EMA validated taletrectinib Marketing Authorisation Application with standard review timeline

Negative

• None.

News Market Reaction – NUVB

+1.07%

18 alerts

+1.07% Session close to close

+2.9% Peak in 1 hr 53 min

$1.75B Market Cap

0.3x Rel. Volume

In the May 27 session, NUVB gained 1.07%, reflecting a mild positive market reaction. Argus tracked a peak move of +2.9% during that session. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement emphasizes patient-reported outcomes from the TRUST-II study, showing that 88% of ...

Analysis

This announcement emphasizes patient-reported outcomes from the TRUST-II study, showing that 88% of patients experienced improved or stable quality of life and high rates of relief from cough and shortness of breath. These data complement earlier efficacy and regulatory milestones for IBTROZI. Investors may watch how this quality-of-life profile supports ongoing global regulatory efforts, including the European MAA and the U.S. sNDA, and how future TRUST-IV Phase 3 results evolve the early-stage disease opportunity.

Key Figures

Stable/improved QoL: 88% of TRUST-II patients TRUST-II sample size: 69 patients TKI-naïve subgroup: 23 patients +5 more

8 metrics

Stable/improved QoL 88% of TRUST-II patients Reported improved or stable quality of life at first assessment

TRUST-II sample size 69 patients Advanced ROS1+ NSCLC patients in North America and Europe

TKI-naïve subgroup 23 patients TRUST-II TKI-naïve ROS1+ NSCLC cohort

TKI-pretreated subgroup 46 patients TRUST-II TKI-pretreated ROS1+ NSCLC cohort

TKI-pretreated QoL 93% of patients Reported improved or stable global health QoL at first assessment

Cough/dyspnea relief 84–96% of patients Improved or stable cough and shortness of breath scores at first assessment

Disease stage Stage IB–IIIA Population for TRUST-IV adjuvant taletrectinib Phase 3 trial

FDA sNDA action date January 4, 2027 Target action date for IBTROZI sNDA with updated data

Historical Context

5 past events · Latest: May 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 13	Manufacturing partnership	Positive	-1.3%	Thermo Fisher collaboration for U.S.-based IBTROZI manufacturing and supply security.
May 06	Regulatory sNDA update	Positive	+4.3%	FDA acceptance of IBTROZI sNDA with extended TRUST-I/II efficacy follow-up.
May 05	Investor conferences	Neutral	+4.3%	Management participation in several oncology-focused and general investor conferences.
May 04	Earnings and update	Positive	+9.5%	Q1 2026 results with IBTROZI revenue, strong cash position, and pooled TRUST data.
Apr 27	Guideline inclusion	Positive	-6.8%	NCCN added taletrectinib as systemic option for CNS cancers with brain metastases.

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

Pattern Detected

Positive clinical and regulatory updates have often led to gains, but guideline and partnership news saw negative reactions.

Recent Company History

Over the last month, Nuvation Bio has delivered multiple positive milestones for IBTROZI, including FDA sNDA acceptance with extended follow-up data on May 6, 2026, strong Q1 financials and pooled TRUST data on May 4, 2026, and NCCN CNS guideline inclusion on April 24, 2026. Reactions have been mixed: some events triggered gains above 4% while others, including a partnership manufacturing deal and guideline update, saw declines, underscoring inconsistent trading responses to good news.

Key Terms

non-small cell lung cancer, patient-reported outcomes, health-related quality of life, phase 2, +4 more

8 terms

non-small cell lung cancer medical

"taletrectinib) in patients with ROS1-Positive Non-Small Cell Lung Cancer at ASCO"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

patient-reported outcomes medical

"announced new patient-reported outcomes data from the pivotal TRUST-II study"

Reports provided directly by patients about their symptoms, daily functioning, and quality of life—collected through surveys, apps, or interviews—reflecting how a treatment affects real people rather than lab measures. Investors care because these firsthand accounts help regulators, doctors and payers judge a product’s real-world value and can influence approval, pricing, adoption and long-term sales; think of them as customer reviews that show whether a medical product truly improves everyday life.

health-related quality of life medical

"outcomes (PROs) and health-related quality of life (HRQoL) with taletrectinib"

A measure of how a person’s health status affects their ability to live, work and enjoy life, covering physical comfort, mental well‑being and social participation, usually captured by patient questionnaires and numeric scores. Investors care because improvements in these scores can drive regulatory approval, insurance coverage, patient demand and pricing, much like customer satisfaction ratings predict whether a product will sell and generate revenue.

phase 2 medical

"TRUST-II is a global Phase 2 study evaluating the safety and efficacy"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 3 medical

"Trial in progress: Randomized, double-blind, Phase 3 TRUST-IV study of adjuvant"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

adjuvant medical

"Phase 3 TRUST-IV study of adjuvant taletrectinib vs placebo"

An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.

supplemental New Drug Application regulatory

"the FDA accepted a supplemental New Drug Application (sNDA) with updated data"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

Marketing Authorisation Application regulatory

"Marketing Authorisation Application (MAA) for taletrectinib was validated"

A marketing authorisation application is the formal package a drug or medical-device maker submits to a health regulator to get permission to sell a product. Think of it as an application for a sales license: regulators review safety, effectiveness and manufacturing quality before granting permission. Investors watch these submissions because approval unlocks revenue and reduces development risk, while rejection or delays can materially affect a company’s value and timeline.

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

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 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

NEW YORK, May 27, 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 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.

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.

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 May 4, 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

What quality-of-life data for IBTROZI were presented by Nuvation Bio (NUVB) at ASCO 2026?

Nuvation Bio reported that 88% of TRUST-II patients had improved or stable global quality-of-life at first assessment. According to Nuvation Bio, this benefit, including preserved cognitive function and symptom relief, was generally sustained across subsequent treatment cycles in advanced ROS1-positive non-small cell lung cancer.

How did IBTROZI (taletrectinib) affect cough and shortness of breath in TRUST-II ROS1+ NSCLC patients?

IBTROZI was associated with rapid relief of cough and shortness of breath in TRUST-II patients. According to Nuvation Bio, 84–96% of participants reported improved or stable scores for these symptoms at first assessment, with sustained improvements through eight months of treatment.

What cognitive function outcomes were observed with IBTROZI in the TRUST-II Phase 2 trial of ROS1+ NSCLC?

Cognitive function scores improved or remained stable for patients treated with IBTROZI in TRUST-II. According to Nuvation Bio, quality-of-life and cognitive measures stayed improved or stable over time in both TKI-naïve and TKI-pretreated advanced ROS1-positive non-small cell lung cancer populations.

What are the key regulatory milestones for IBTROZI (taletrectinib) noted in the May 27, 2026 NUVB update?

IBTROZI is already FDA-approved in the US for locally advanced or metastatic ROS1+ NSCLC. According to Nuvation Bio, an FDA sNDA is under review with a January 4, 2027 target action date, and an EMA Marketing Authorisation Application has been validated.

In which regions is IBTROZI currently approved for advanced ROS1-positive NSCLC patients?

IBTROZI is approved in the United States, Japan, and China for advanced ROS1+ NSCLC. According to Nuvation Bio, it is marketed by Nippon Kayaku in Japan and by Innovent Biologics in China under the brand name DOVBLERON, alongside Nuvation’s own commercialization efforts.

What is the design of the TRUST-II study of IBTROZI in ROS1-positive non-small cell lung cancer?

TRUST-II is a global Phase 2 trial evaluating IBTROZI’s safety and efficacy in advanced ROS1+ NSCLC. According to Nuvation Bio, it includes 69 patients from North America and Europe, covering both TKI-naïve and TKI-pretreated groups, with detailed patient-reported outcome assessments.

What is the TRUST-IV Phase 3 trial of taletrectinib that Nuvation Bio highlighted at ASCO 2026?

TRUST-IV is a randomized, double-blind Phase 3 study of adjuvant taletrectinib versus placebo in stage IB–IIIA ROS1+ NSCLC. According to Nuvation Bio, it is a trial-in-progress, with details presented in a poster session at the ASCO 2026 Annual Meeting.