Crizotinib

Research presented includes work from 40 authors across the Sarah Cannon Research Institute network of research sites NASHVILLE, Tenn.--(BUSINESS WIRE)-- Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, will highlight its latest research insights through more than 85 abstracts and presentations at the annual European Society for Medical Oncology (ESMO) conference in Madrid, Spain, from October 23-27. Each year, ESMO brings together thousands of leading researchers, physicians and oncology professionals from around the world to share the latest advances shaping the future of cancer care. SCRI thought leaders are presenting recent findings from several early- and late-phase clinical trials focused on a variety of targeted treatment approaches like antibody drug conjugates (ADCs), immunotherapies and bispecifics. “Each abstract presented by SCRI investigators at ESMO represents our mission to bring cutting-edge cancer research closer to patients,” said David R. Spigel, MD, President and Chief Medical Officer, SCRI. “Our investigators are helping answer critical questions across a wide range of tumor types and treatment approaches, all with the goal of accelerating progress for patients. We’re honored to share these findings and contribute to conversations that will help define the next generation of cancer care.” Notable presentations include: Benjamin Garmezy, MD, SCRI , will present “Safety and efficacy of JNJ-6143, a first-in-class oral AR-targeted RIPTAC™ at the optimal dose for further development in patients with mCRPC/mAPMR, including high-risk molecular features” in an oral presentation on October 24, 2026 , from 10:35 a.m. to 10:45 a.m. , during a session in the Barcelona Auditorium (Hall 9) . Meredith McKean, MD, MPH, SCRI , will present “Patritumab Deruxtecan (HER3-DXd) in Melanoma After Anti-PD-(L)1 Therapy: Primary Analysis From HERTHENA-PanTumor01” in an oral presentation on October 25, 2026 , from 10:20 a.m. to 10:25 a.m. , during a session in the Bilbao Auditorium (Hall 3) . October 25 at 4:30 p.m., “ Krascendo 1: efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC” will be presented in Hall 6 of the Alicante Auditorium. This research was co-authored by Bo Wang, MD, SCRI at Willamette Valley Cancer Institute and Research Center | The US Oncology Network. Dax Kurbegov, MD, Sarah Cannon Cancer Network , will present “Efficiency and Safety of Cancer Signal Origin (CSO)-Guided Diagnostic Workups Following Multi-Cancer Early Detection (MCED) Testing: Results from PATHFINDER 2 (PF2)” in an oral presentation on October 26, 2026 , from 3:22 p.m. to 3:27 p.m. , during a session in the Salamanca Auditorium (Hall 10) . Erika Hamilton, MD, SCRI , will deliver a presentation on Next Generation Therapies during the Novel Concepts for Metastatic Breast Cancer session on October 24 at 4:45 p.m . in Hall 9 of the Barcelona Auditorium. October 25, Melissa Johnson, MD , SCRI , will also take part in a panel discussion on non-small cell lung cancer at 10:15 a.m. in Hall 6 of the Alicante Auditorium. Additional SCRI First-Author Poster Presentations Breast Cancer Dr. Erika Hamilton will present “Efficacy, safety, and biomarker analysis of DB-1310 (HER3-targeted ADC) in pretreated HR+/HER2- breast cancer: Updated global phase 1/2a trial” on October 24, 2026 , from 12:00 p.m. to 12:45 p.m. Nina Balanchivadze, MD, SCRI at Virginia Oncology Associates | The US Oncology Network , will present “Real world (RW) outcomes in HR+/HER2- metastatic breast cancer (mBC) patients, by second-line (2L) treatment” on October 24, 2026 . Judy S. Wang, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network will present “First-in-class Rac/Cdc42 inhibitor MBQ-167 in patients with metastatic breast cancer (MBC): safety and preliminary efficacy” on October 24, 2026 , from 12:00 p.m. to 12:45 p.m. Genitourinary Cancer Dr. Benjamin Garmezy will present “A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)” on October 23, 2026 , from 3:15 p.m. to 4:00 p.m. in Hall 5 . Gynecologic Cancer Noelle Cloven, MD, SCRI at Texas Oncology | The US Oncology Network will present “Defining the Molecular Landscape of HRD Negative Ovarian Cancer: A Real World Data Set to Enable Synthetic Control Arm Generation” on October 25, 2026 from 12:00 p.m. to 12:45 p.m. Head & Neck Cancer Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network will present “A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients with advanced solid tumors that express CA19-9” on October 24, 2026 , from 3:15 p.m. to 4:00 p.m. Lung Cancer David Spigel, MD, SCRI , will present “Deep-Learning Serial CT Imaging Predictions of Survival Compared with RECIST 1.1 Objective Response Rate in Immunotherapy-Treated NSCLC.” Dr. Melissa Johnson will present “First-line (1L) Olomorasib + Pembrolizumab in KRAS G12C-Mutant NSCLC: Updated Results from LOXO-RAS-20001 and SUNRAY-01” on October 26, 2026 , from 12:00 p.m. to 12:45 p.m. Dr. Bo Wang will present “TeLuRide-005: Phase 2 study of EIK1001 (TLR7/8 dual agonist) plus pembrolizumab and chemotherapy in patients with stage IV NSCLC: results from the squamous cohort and updated pooled results” on October 26, 2026 , from 12:00 p.m. to 12:45 p.m. Elisa Fontana, MD, SCRI at HCA Healthcare UK , will present “Prospective validation of artificial intelligence (AI)-assisted RECIST 1.1 in a phase 1 study of fetrastobart vedotin in patients with non-small cell lung cancer (NSCLC)” on October 25, 2026 , from 12:00 p.m. to 12:45 p.m. Skin Cancer Dr. Meredith McKean will present “Darovasertib and Crizotinib for HLA-A 02 –Positive Metastatic Uveal Melanoma: Results from the Phase 2 OptimUM-01 Study ” on October 24, 2026 , from 12:00 p.m. to 12:45 p.m. Additional Presentations Dr. Melissa Johnson will present “Preliminary safety and pharmacokinetics of TJ101, an EGFR × B7-H3 bispecific antibody-drug conjugate, in patients with advanced solid tumors: results from an ongoing global Phase I study” on October 23, 2026 , from 3:15 p.m. to 4:00 p.m. Gerald Falchook, MD, SCRI at HCA HealthONE , will present “AXL inhibitor AB801 in patients with advanced malignancy: Dose escalation results from the phase 1/1b ARC-27 study” on October 23, 2026 , from 3:15 p.m. to 4:00 p.m. Additionally, Dr. Falchook will present “Dose optimization of ragistomig (ABL503/TJ-L14B), a PD-L1 x 4-1BB Bispecific Antibody” on October 23, 2026 , from 3:15 p.m. to 4:00 p.m. and “Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors” on October 23, 2026 , from 3:15 p.m. to 4:00 p.m. About Sarah Cannon Research Institute (SCRI) Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 1,000 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together approximately 1,500 oncology physicians who provide access to clinical trials in SCRI’s research network of over 200 locations in more than 20 states across the U.S. Visit SCRI.com to learn more . Contacts Media Contact Chelsea Bryant Chelsea.Bryant@SCRI.com (615) 308-6103

Updated label reflects TRUST-I TKI-naïve median duration of response of nearly 50 months No changes to the safety sections of labeling with longer follow-up and no new safety signals identified Approval comes four months ahead of PDUFA date NEW YORK, Sept. 16, 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 the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for IBTROZI® (taletrectinib), a ROS1 inhibitor approved for the treatment of locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The updated IBTROZI label now reflects updated median duration of response (DOR) for the TRUST-I study, with a median DOR of 49.7 months in TKI-naïve patients in TRUST-I, reflecting more than four years of sustained clinical benefit. This update came with no changes to the safety sections of labeling, with no new signals identified with longer follow-up, confirming the safety profile. The sNDA approval reflects a median follow-up of 51 months for patients from the TRUST-I study and incorporates an additional 14 months of data from both of the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff. Many patients remained on therapy for extended periods with a continued response—some for multiple years—highlighting the long-term durability and tolerability of IBTROZI and reinforcing its importance as a treatment option for advanced ROS1+ NSCLC. These data were also presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 and simultaneously published in the Journal of Clinical Oncology. "This approval is a significant milestone for IBTROZI because this data is now part of the FDA-approved label, something physicians and patients can turn to directly," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "A median duration of response of more than four years—the longest median DOR reported for an FDA-approved ROS1 TKI—is a remarkable outcome for people living with ROS1+ NSCLC, and having it in the label means something real for patients: a clearer sense of how long they might expect to stay on treatment, and more confidence in what that path could look like at a moment when a new diagnosis can feel overwhelming. It also gives physicians additional evidence to support using IBTROZI early in a patient's care, when that choice matters most." The U.S. FDA granted full approval to IBTROZI in June 2025 for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy. 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, the Company, along with its partner, Eisai, announced in March 2026 that the Marketing Authorisation Application (MAA) for taletrectinib was validated by the European Medicines Agency (EMA) for full approval consideration with a standard review timeline, and in June 2026 that the MAA was validated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. 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 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, as well as EMA and MHRA regulatory review timelines and potential outcomes. 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-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 [email protected] Nuvation Bio Media Contact Kaitlyn Nealy [email protected] SOURCE Nuvation Bio Inc. 21% more press release views with Request a Demo