{"id":989261,"date":"2026-08-04T09:27:47","date_gmt":"2026-08-04T13:27:47","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nuvation-bio-to-present-new-subgroup-analyses-of-pivotal-data-for-ibtrozi-taletrectinib-in-advanced-ros1-positive-non-small-cell-lung-cancer-at-wclc-and-esmo-annual-congresses\/"},"modified":"2026-08-04T09:27:47","modified_gmt":"2026-08-04T13:27:47","slug":"nuvation-bio-to-present-new-subgroup-analyses-of-pivotal-data-for-ibtrozi-taletrectinib-in-advanced-ros1-positive-non-small-cell-lung-cancer-at-wclc-and-esmo-annual-congresses","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nuvation-bio-to-present-new-subgroup-analyses-of-pivotal-data-for-ibtrozi-taletrectinib-in-advanced-ros1-positive-non-small-cell-lung-cancer-at-wclc-and-esmo-annual-congresses\/","title":{"rendered":"Nuvation Bio to Present New Subgroup Analyses of Pivotal Data for IBTROZI\u00ae (taletrectinib) in Advanced ROS1-Positive Non-Small Cell Lung Cancer at WCLC and ESMO Annual Congresses"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n Analyses of long-term TRUST-I and TRUST-II data will examine consistency of efficacy across key patient subgroups<\/i>\n <\/p>\n

\n NEW YORK<\/span>, Aug. 4, 2026<\/span> \/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 analyses of long-term Phase 2 TRUST-I and TRUST-II data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) taking place September 12\u201315, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology Congress (ESMO) October 23\u201327, 2026, in Madrid, Spain. These findings from the pivotal Phase 2 studies\u00a0will feature the efficacy and safety\u00a0of IBTROZI\u00ae <\/sup>(taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) across key patient subgroups.<\/p>\n

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\n \"Nuvation\n <\/p>\n<\/p><\/div>\n

“Every patient has a unique treatment journey, and physicians need confidence that a therapy can deliver consistent, long-term benefit across a broad range of patients,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “At WCLC and ESMO, we look forward to presenting subgroup analyses of our pivotal data, including for patients previously treated with earlier-generation ROS1 inhibitors, that will further underscore the durable clinical benefits of IBTROZI demonstrated in our long-term data and reinforce its potential as a standard of care across all lines of advanced ROS1-positive NSCLC.”<\/p>\n

\n Presentations Overview:<\/b>\n <\/p>\n

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\n WCLC<\/b>
\n <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

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\n Title: <\/b>Taletrectinib Across Key Subgroups in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From TRUST-I and TRUST-II<\/span>\n <\/p>\n

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\n Presenter: <\/b>Hidetoshi Hayashi, Kindai University Faculty of Medicine, Osaka, Japan<\/span>\n <\/p>\n

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\n Date: <\/b>Tuesday, September 15, 2026\u00a0<\/span>\n <\/p>\n

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\n Session Time: <\/b>9:30-11:00 a.m. KST<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

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\n ESMO<\/b>
\n <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

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\n Title: <\/b>Updated Efficacy and Safety of Taletrectinib in Patients with Advanced ROS1+ Non-Small Cell Lung Cancer (NSCLC) After Prior Entrectinib Exposure: Results from the Global TRUST-II Study<\/span>\n <\/p>\n

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\n Presenter<\/b>: Maurice P\u00e9rol, Department of Medical Oncology, L\u00e9on B\u00e9rard Cancer Center, Lyon, France<\/span>\n <\/p>\n

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\n Date: <\/b>Monday, October 26, 2026<\/span>\n <\/p>\n

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\n Session Time:<\/b>\u00a012:00-12:45 p.m. CEST<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

The materials will be made available in the Publications<\/a><\/b>\u00a0section of Nuvation Bio’s website after the presentations. To meet representatives from Nuvation Bio, visit Booth #115 at WCLC and Booth #1080 at ESMO.<\/p>\n

\n About ROS1+ NSCLC<\/b>
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Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form\u00a0of lung cancer. It is estimated that approximately 2%\u00a0of 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.<\/p>\n

\n About IBTROZI
<\/b>IBTROZI is an oral, potent,\u00a0CNS-active, selective, next-generation ROS1 inhibitor therapy.\u00a0On June 11,\u00a02025,\u00a0following Priority Review and Breakthrough Therapy\u00a0designations for both TKI-naive and TKI-pretreated disease,\u00a0the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.\u00a0Learn more about taletrectinib in the U.S. at IBTROZI.com<\/a><\/b>.<\/p>\n

\n About the TRUST Clinical Program<\/b>
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The TRUST clinical program\u00a0comprises\u00a0three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677<\/a><\/b>) and TRUST-II (NCT04919811<\/a><\/b>) 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\u00a0confirmed\u00a0objective\u00a0response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706<\/a><\/b>) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with\u00a0resected\u00a0early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe,\u00a0Japan\u00a0and China. The primary endpoint is disease-free survival as\u00a0determined\u00a0by\u00a0investigator, and the primary completion date is estimated to be in 2030. Nuvation\u00a0Bio\u00a0is also sponsoring TRUST-III (NCT06564324<\/a><\/b>), 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.\u00a0<\/p>\n

\n U.S. Indication
<\/b>IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).<\/p>\n

\n IMPORTANT SAFETY INFORMATION FOR IBTROZI<\/b>
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\n \u00ae<\/sup>
\n <\/b>\u00a0(taletrectinib)<\/b>\u00a0<\/p>\n

\n WARNINGS AND PRECAUTIONS<\/b>\n <\/p>\n

\n Hepatotoxicity:<\/b>\u00a0Hepatotoxicity, 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\u00a0time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).<\/p>\n

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\u00a00.3% and by hepatotoxicity in 0.6% of patients.<\/p>\n

Concurrent elevations in AST or ALT \u22653 times the ULN and total bilirubin \u22652 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.<\/p>\n

\n Interstitial Lung Disease (ILD)\/Pneumonitis:<\/b>\u00a0Severe, life-threatening, or fatal ILD or pneumonitis can occur.\u00a0ILD\/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3\/4. One fatal ILD case occurred at the 400\u00a0mg\u00a0daily dose. Median\u00a0time to\u00a0first onset of ILD\/pneumonitis was 3.8 months (range: 12 days\u00a0to 11.8 months).<\/p>\n

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.<\/p>\n

\n QTc Interval Prolongation:<\/b>\u00a0QTc 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.<\/p>\n

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60\u00a0msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade \u22653. Median\u00a0time 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\u00a0occurred in 2.8% of patients.<\/p>\n

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.<\/p>\n

\n Hyperuricemia:<\/b>\u00a0Hyperuricemia 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 \u22653.\u00a0Median\u00a0time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.<\/p>\n

\n Myalgia with Creatine Phosphokinase (CPK) Elevation:<\/b>\u00a0Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median\u00a0time to first onset was 11 days (range: 2 days to 10 months).<\/p>\n

Concurrent myalgia with increased CPK within a 7-day time period\u00a0occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.<\/p>\n

\n Skeletal Fractures:<\/b>\u00a0IBTROZI 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\u00a0time to first onset of fracture was 10.7 months (range: 26 days\u00a0to 29.1 months). Dose interruption occurred in 0.3% of patients.<\/p>\n

\n Embryo-Fetal Toxicity:<\/b>\u00a0Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.<\/p>\n

\n ADVERSE REACTIONS
<\/b>Among patients who received IBTROZI, the most frequently reported adverse reactions (\u226520%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).<\/p>\n

The most frequently reported Grade 3\/4 laboratory abnormalities (\u22655%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).<\/p>\n

\n DRUG INTERACTIONS<\/b>\n <\/p>\n