Nuvation Bio to Present Pivotal IBTROZI® (Taletrectinib) Data in TKI-Naïve and TKI-Pretreated Patients with Advanced ROS1-Positive Non-Small Cell Lung Cancer at AACR 2026

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) will present updated pivotal data for IBTROZI® (taletrectinib) at AACR Annual Meeting 2026 on April 21, 2026.

Updated TRUST-I and TRUST-II results show a median duration of response (DOR) of 50 months in TKI-naïve ROS1+ NSCLC as of the August 2025 cutoff, and new data in TKI-pretreated patients will be reported.

Positive

• DOR 50 months in TKI-naïve ROS1+ NSCLC (August 2025 cutoff)
• Line-agnostic FDA approval for IBTROZI in June 2025
• Updated data for TKI-pretreated ROS1+ patients to be presented at AACR

Negative

• None.

News Market Reaction – NUVB

-2.73%

1 alert

-2.73% News Effect

On the day this news was published, NUVB declined 2.73%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Median DOR: 50 months FDA approval date: June 2025 AACR 2026 dates: April 17–22, 2026 +5 more

8 metrics

Median DOR 50 months TKI-naïve advanced ROS1+ NSCLC as of August 2025 data cutoff

FDA approval date June 2025 Line-agnostic FDA approval for IBTROZI in ROS1+ NSCLC

AACR 2026 dates April 17–22, 2026 American Association for Cancer Research Annual Meeting 2026

Oral session time 2:30–4:30 p.m. PST TKI-naïve taletrectinib presentation on April 21, 2026

Poster session time 2:00–5:00 p.m. PST TKI-pretreated and ROS1 inhibitor profile posters on April 21, 2026

Abstract number #CT300 Oral presentation in TKI-naïve ROS1+ NSCLC

Abstract number #CT244 Poster in TKI-pretreated ROS1+ NSCLC

Booth number 4459 Nuvation Bio booth at AACR Annual Meeting

Market Reality Check

Price: $4.28 Vol: Volume 3,308,717 is below...

low vol

$4.28 Last Close

Volume Volume 3,308,717 is below the 20-day average of 5,546,735, suggesting a moderate participation level ahead of AACR data. low

Technical Price at $4.40 is trading slightly below the 200-day MA of $4.55, with shares also 54.87% below the 52-week high and 185.71% above the 52-week low.

Peers on Argus

NUVB gained 1.35% with mixed moves among biotech peers: ELVN and ZYME were up, O...

1 Up

NUVB gained 1.35% with mixed moves among biotech peers: ELVN and ZYME were up, ORIC was down, and only RCUS showed momentum scanner activity. This pattern points to a stock-specific reaction to the IBTROZI AACR update rather than a broad sector rotation.

Historical Context

5 past events · Latest: Mar 02 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 02	Earnings and update	Positive	-25.3%	Reported Q4/FY25 results, IBTROZI launch metrics, cash position and business update.
Feb 25	Investor conferences	Neutral	-1.4%	Announced participation in four March 2026 investor conferences with fireside chats.
Feb 17	Earnings date set	Neutral	-1.9%	Scheduled Q4/FY25 earnings release and webcast for March 2, 2026.
Feb 09	Phase 3 trial upgrade	Positive	-1.1%	Converted safusidenib SIGMA study to pivotal Phase 3 with expanded enrollment to 300.
Jan 12	Prelim earnings/outlook	Positive	-19.6%	Released preliminary 4Q25 metrics, IBTROZI revenues, $25M milestone and Eisai license.

Pattern Detected

Recent history shows several positive clinical/commercial updates followed by negative price reactions, indicating a tendency for the stock to sell off or underperform after ostensibly favorable news.

Recent Company History

Over the last few months, Nuvation Bio reported multiple milestones, including pivotal Phase 3 initiation for safusidenib, preliminary and final 4Q25/full‑year 2025 results, and strong IBTROZI launch metrics with 216 new patient starts in Q4 and $24.7M net product revenue since launch. Despite these updates and a sizeable cash position of $529.2M, prior earnings and clinical announcements were followed by share price declines. Against this backdrop, the AACR 2026 IBTROZI durability data extend the clinical story after the June 2025 FDA approval.

Market Pulse Summary

This announcement highlights long-term IBTROZI performance, with a median duration of response of 50...

Analysis

This announcement highlights long-term IBTROZI performance, with a median duration of response of 50 months in TKI‑naïve ROS1+ NSCLC and nearly an extra year of follow‑up beyond the June 2025 approval dataset. Investors can relate this to prior milestones, including strong launch metrics and pivotal Phase 3 advancement for safusidenib. Key factors to watch include future clinical updates, commercialization metrics, and how upcoming AACR presentations are received.

Key Terms

duration of response, dOR, tyrosine kinase inhibitor, TKI, +4 more

8 terms

duration of response medical

"with median Duration of Response (DOR) now increased to 50 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.

dOR medical

"with a median duration of response (DOR) now exceeding four years"

DOR, short for “date of record,” is the cutoff day a company uses to decide which shareholders are eligible for a dividend, stock split, or the right to vote at a meeting. It matters to investors because ownership on that specific day—like being on a guest list when names are checked—determines whether you receive the payment or voting power, so buying or selling around the DOR affects your entitlements.

tyrosine kinase inhibitor medical

"Taletrectinib in tyrosine kinase inhibitor (TKI)-naïve patients with ROS1+"

A tyrosine kinase inhibitor is a type of drug that blocks specific proteins in cells that act like on/off switches for growth and survival signals, often used to stop cancer cells from multiplying. For investors, these drugs matter because their clinical trial results, regulatory approvals, safety profiles, and patent status drive sales potential and company valuation—think of them as precision tools whose effectiveness and market exclusivity determine commercial success.

TKI medical

"taletrectinib in TKI-pretreated patients with ROS1+ NSCLC"

A TKI (tyrosine kinase inhibitor) is a type of drug that blocks specific enzymes cells use to send growth signals, effectively slowing or stopping the proliferation of certain cancer and disease cells. For investors, TKIs matter because they are often central to a biotech company's product pipeline and revenue potential: successful TKIs can win regulatory approval, command premium pricing, and shift competitive dynamics in treatment markets, much like a key component that can make or break a new technology's commercial success.

non-small cell lung cancer medical

"ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)"

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.

NSCLC medical

"ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)"

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

ROS1-positive medical

"advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)"

ROS1-positive describes a tumor that carries a specific genetic change in the ROS1 gene, meaning the cancer cells use an abnormal instruction that can drive their growth. For investors, this matters because ROS1-positive status identifies patients who may respond to targeted drugs designed like a key fitting a particular lock, shaping the potential market size, trial outcomes, regulatory approvals, and revenue prospects for therapies aimed at that patient group.

Phase II Clinical Trials medical

"Session Title: Phase II Clinical Trials"

Phase II clinical trials are studies that evaluate whether an experimental drug or therapy actually works and is reasonably safe in a larger group of patients after initial safety checks. Investors care because results provide the first meaningful evidence of effectiveness and side effects—like a prototype tested with real users—informing whether a program is likely to advance, shaping a drug’s future value and the company’s funding and partnership prospects.

AI-generated analysis. Not financial advice.

Clinical data demonstrate IBTROZI's unprecedented durability in TKI-naïve advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), with median Duration of Response (DOR) now increased to 50 months as of August 2025 data cutoff

Presentations will also highlight new data on the efficacy and safety of taletrectinib in TKI-pretreated patients with ROS1+ NSCLC

NEW YORK, March 17, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026 taking place April 17–22, 2026, in San Diego, California. These data include updated results from the TRUST-I and TRUST-II clinical studies highlighting the efficacy and safety of IBTROZI^® (taletrectinib) for the treatment of ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in both tyrosine kinase inhibitor (TKI)-naïve and TKI-pretreated patients with ROS1+ NSCLC. The data to be presented represent nearly an additional year of follow-up from the data that supported IBTROZI's line-agnostic FDA approval in June 2025.

"We're excited to present even longer-term follow-up data from our pivotal trials for IBTROZI, which further reinforce the depth and durability of responses in patients with advanced ROS1+ NSCLC across lines of therapy," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "In particular, with a median duration of response (DOR) now exceeding four years in TKI-naïve patients, these data continue to highlight IBTROZI's sustained and clinically meaningful benefit for patients with a manageable safety profile."

Oral Presentation Overview:
Title: Taletrectinib in tyrosine kinase inhibitor (TKI)-naïve patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II
Presenter: Lyudmila Bazhenova, M.D., Moores Cancer Center, University of California San Diego
Session Category: Advances in Precision Oncology
Date: Tuesday, April 21, 2026
Session Time: 2:30-4:30 p.m. PST
Abstract Number: #CT300

Poster Presentations Overview:
Title: Taletrectinib in tyrosine kinase inhibitor (TKI)-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II
Presenter: Geoffrey Liu, M.Sc., M.D., Professor, Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto
Session Title: Phase II Clinical Trials
Date: Tuesday, April 21, 2026
Session Time: 2:00-5:00 p.m. PST
Poster Board Number: 9
Abstract Number: #CT244

Title: Taletrectinib, a next-generation selective ROS1 inhibitor, demonstrates a differentiated profile in ROS1 fusion models
Presenter: Hitisha Patel, Ph.D., Senior Director of Research, Nuvation Bio
Session Category: Experimental and Molecular Therapeutics
Session Title: Tyrosine Kinase, Phosphatase, and Other Inhibitors
Date: Tuesday, April 21, 2026
Session Time: 2:00-5:00 p.m. PST
Poster Board Number: 2
Abstract Number: #5864

The materials will be made available in the Publications section of Nuvation Bio's website after the sessions. To learn more about Nuvation Bio, visit Booth #4459 at the AACR Annual Meeting.

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 138 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 IBTROZI'S therapeutic potential and new data to be presented. 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 conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; 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-K filed with the SEC on March 2, 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

View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-to-present-pivotal-ibtrozi-taletrectinib-data-in-tki-naive-and-tki-pretreated-patients-with-advanced-ros1-positive-non-small-cell-lung-cancer-at-aacr-2026-302716514.html

SOURCE Nuvation Bio Inc.

FAQ

What updated IBTROZI data will NUVB present at AACR 2026 on April 21, 2026?

NUVB will present updated TRUST-I and TRUST-II trial results, including efficacy and safety in both TKI-naïve and TKI-pretreated ROS1+ NSCLC patients. According to the company, the dataset includes nearly an additional year of follow-up versus prior reports.

How long is the median duration of response reported for IBTROZI in TKI-naïve ROS1+ NSCLC?

The median duration of response (DOR) in TKI-naïve ROS1+ NSCLC is reported at 50 months as of the August 2025 cutoff. According to the company, this reflects extended durability from pivotal TRUST-I and TRUST-II datasets supporting earlier approval.

Does NUVB report data for TKI-pretreated ROS1+ NSCLC patients at AACR 2026?

Yes, NUVB will present updated efficacy and safety data for taletrectinib in TKI-pretreated ROS1+ NSCLC patients at AACR. According to the company, these poster and oral sessions detail outcomes from TRUST-I and TRUST-II studies.

When and where will the NUVB oral presentation on taletrectinib occur at AACR 2026?

The oral presentation is scheduled for Tuesday, April 21, 2026, from 2:30–4:30 p.m. PST in San Diego. According to the company, the session is in the Advances in Precision Oncology category (Abstract #CT300).

What regulatory status does IBTROZI have as referenced in the AACR announcement for NUVB?

IBTROZI holds a line-agnostic FDA approval granted in June 2025. According to the company, the AACR data add nearly a year of follow-up to the evidence supporting that approval.

Where can investors access NUVB's AACR presentation materials after the sessions?

Presentation materials will be posted in the Publications section of NUVB's website after the sessions conclude. According to the company, additional information will also be available at Booth #4459 during the AACR meeting.