Ibtrozi (taletrectinib) / Daiichi Sankyo, Innovent Biologics, NewG Lab Pharma, Nippon Kayaku, Nuvation Bio - LARVOL DELTA

Subgroup analysis of japanese patients in the phase II study of taletrectinib in patients with ROS1+ NSCLC: The global TRUST-II study (ESMO Asia 2025) - P2 | "In 10 TKI-pretreated pts (7 crizotinib, 3 entrectinib), cORR 70% (95% CI: 34.8, 93.3), IC-cORR 100% (95% CI: 29.2, 100; 3/3), and median DOR 19.4 months (95% CI: 2.8, NE). Taletrectinib continues to show high and durable overall responses, robust intracranial activity, in Japanese ROS1+ NSCLC both in TKI-naïve and -pretreated in the TRUST-II study. The safety profile, including low neurologic adverse events, was consistent with entire cohort, supporting its efficacy and tolerability in this population."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Next-Generation Targeted Therapy: The Evolving Role of Taletrectinib in Fusion-Positive Malignancies. (PubMed, Zhongguo Ying Yong Sheng Li Xue Za Zhi) - "First-generation tyrosine kinase inhibitors (TKIs) such as crizotinib displayed significant early reactions but faced challenges due to restricted central nervous system (CNS) penetration and mutation resistance, while entrectinib and larotrectinib expanded treatment options but also experienced resistance...Safety data shows an acceptable toxicity profile, mainly featuring gastrointestinal and hepatic adverse effects, with fewer neurocognitive side effects compared to lorlatinib...Current trials and regulatory activities in China, the U.S., and other locations demonstrate taletrectinib's growing clinical significance. Taletrectinib's well-rounded pharmacological attributes of systemic action, intracranial effectiveness, resistance range, and tolerability render it an intriguing enhancement to the framework of precision oncology."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NTRK • ROS1

Evolving Therapeutic Landscape of ROS1-Positive Non-Small Cell Lung Cancer: An Updated Review. (PubMed, Curr Oncol) - "Crizotinib first demonstrated substantial clinical benefit, but its limitations, including poor central nervous system (CNS) penetration and acquired resistance, highlighted the need for next-generation inhibitors. Several agents have since been developed, including entrectinib, lorlatinib, repotrectinib, taletrectinib, and zidesamtinib, each offering improved intracranial (IC) activity and efficacy against resistance mutations, notably ROS1^G2032R. Despite these advances, optimal sequencing strategies remain undefined, and resistance ultimately emerges in most patients. This review provides an updated overview of ROS1 biology, diagnostic approaches, clinical outcomes with currently available TKIs, mechanisms of resistance, and ongoing challenges, emphasizing the rapidly evolving therapeutic landscape."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

In the updated NRDL, DOVBLERON (taletrectinib) is newly listed for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC (PRNewswire)

Reimbursement • Non Small Cell Lung Cancer

Nippon Kayaku Co., Ltd…was listed today on the National Health Insurance (NHI) drug price list and has been launched. (Nippon Kayaku Press Release) - "Nippon Kayaku will promote the proper use of IBTROZI for the approved indication of 'ROS1 fusion gene positive unresectable, advanced and/or recurrent NSCLC' and will strive to provide scientific and medical information under applicable regulations and guidelines and ensure a stable supply, so as to further contribute to patients, their families, and healthcare professionals."

Reimbursement • Non Small Cell Lung Cancer

Launch Price Dynamics of Targeted Therapies in NSCLC: Dissecting the Cost and Value Across Biomarker Segments (ISPOR-EU 2025) - "The variation was evident even within mutation types highlighting potential discrepancies in value (e.g., ROS1: $7,760 [taletrectinib] to $9,693 [repotrectinib] to $13,019 [entrectinib]; RET: $11,393 [selpercatinib] to $15,859[pralsetinib]). Despite relatively consistent monthly costs, cost per mPFS month varies significantly within mutation groups. First-line therapies demonstrate superior value, supporting early biomarker testing. Emerging targeted therapies show potential for further improving value propositions through enhanced clinical outcomes."

Biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • KRAS • ROS1

Taletrectinib: First Approval. (PubMed, Drugs) - "Additional global filings for taletrectinib are underway. This article summarizes the milestones in the development of taletrectinib leading to these first approvals."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), NCCN Guidelines Navigator, the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC™) for Non-Small Cell Lung Cancer, Version 1.2026. (NCCN)

NCCN guideline • Non Small Cell Lung Cancer

PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; durvalumab, cemiplimab, zongertinib, and taletrectinib for lung cancer, pirtobrutinib and atezolizumab for lymphoma, durvalumab for bladder cancer, panitumumab plus sotorasib for colorectal cancer, and vorasidenib for glioma. (PubMed, Int J Clin Oncol) - No abstract available

Japanese regulatory • Journal • Bladder Cancer • Brain Cancer • Colorectal Cancer • Genito-urinary Cancer • Glioma • Hematological Malignancies • Lung Cancer • Lymphoma • Oncology • Solid Tumor

Taletrectinib in ROS1-positive NSCLC: bridging clinical trials and real-world practice. (PubMed, Ann Med Surg (Lond)) - No abstract available

Journal • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Product Revenue, Net (Businesswire) - "To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $7.7 million for the three months ended September 30, 2025."

Sales • Non Small Cell Lung Cancer

IBTROZI (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC (Businesswire) - "Today, the company is announcing that IBTROZI’s median DOR has matured to 50 months as of an August 2025 data cut-off from the pooled TRUST-I and TRUST-II studies. The Company plans to prepare a supplemental New Drug Application (sNDA) to include the updated data in the IBTROZI label and will provide additional data from the August 2025 data cut-off at a medical conference in 2026."

FDA filing • P2 data • Non Small Cell Lung Cancer

Targeting ROS1 in NSCLC: Clinical Advances and Future Directions of Taletrectinib. (PubMed, Zhongguo Ying Yong Sheng Li Xue Za Zhi) - "Findings show that taletrectinib has a promising anticancer impact, good CNS penetration, and a solid safety record, especially in patients with brain metastases. These results imply that ROS1-positive cancers may benefit from taletrectinib as a treatment."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NTRK • ROS1

Pivotal ARROS-1 efficacy and safety data: zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC (JADPRO 2025) - "BACKGROUND • Zidesamtinib is an investigational ROS1 TKI designed to be highly selective, have activity against diverse ROS1 fusions and ROS1 resistance mutations, be brain-penetrant, and avoid TRK inhibition • ARROS-1 is a global, single-arm, first-in-human Phase 1/2 clinical trial of zidesamtinib in advanced ROS1-positive (ROS1+) NSCLC and other solid tumors • Pivotal data for TKI pre-treated ROS1+ NSCLC and preliminary data for TKI-naïve ROS1+ NSCLC are presented ARROS-1 STUDY DESIGN & POPULATIONS • As of the data cut-off date of March 21, 2023, 514 patients with any ROS1+ solid tumor had been enrolled across Phase 1 and 2 – The safety population included 432 patients with advanced ROS1+ NSCLC who received zidesamtinib 100 mg QD – The efficacy population included 117 ROS1 TKI pre-treated patients with measurable disease by BICR and ≥ 6 months duration of response follow-up – The TKI-naïve cohort included 35 patients with measurable disease by BICR..."

Clinical • Metastases • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Lung Cancer • Musculoskeletal Pain • Non Small Cell Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • ROS1

Comparable efficacy and safety of taletrectinib for advanced ROS1+ non–small cell lung cancer across pivotal studies and between races and world regions (JADPRO 2025) - P | "TRUST-I and TRUST-II: Comparable Safety Across Races and Region TRUST-I and TRUST-II: Efficacy TRUST-I and TRUST-II: Comparable Efficacy Across Studies ORR and PFS with taletrectinib at $400$ mg once daily were comparable with historical data on crizotinib (TRUST-I) or with crizotinib (TRUST-II) in $text{ROS1}$-positive $text{NSCLC}$ patients. TEAEs of special interest, including GI events, occurred early and decreased over time. Efficacy was unaffected by dose reductions across the two cohorts."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

TRUST-II global study: Efficacy and safety of taletrectinib after prior entrectinib exposure in patients with advanced ROS1+ non-small cell lung cancer (ESMO 2025) - P2 | "Conclusions Taletrectinib demonstrated robust systemic and intracranial responses with a favorable safety profile in entrectinib-pretreated patients with ROS1+ NSCLC. Overall, taletrectinib was safe and effective as a second-line treatment in this population of patients."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

TRUST-II: Taletrectinib Phase 2 Global Study in ROS1 Positive NSCLC (clinicaltrials.gov) - P2 | N=217 | Active, not recruiting | Sponsor: Nuvation Bio Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2027 ➔ Dec 2027

Enrollment closed • Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New trial • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI (taletrectinib) for the Adjuvant Treatment of ROS1-Positive Early-Stage Non-Small Cell Lung Cancer (Businesswire)

Enrollment open • Non Small Cell Lung Cancer

Pivotal ARROS-1 Efficacy and Safety Data: Zidesamtinib in TKI Pre-treated Patients with Advanced/Metastatic ROS1+ NSCLC (IASLC-WCLC 2025) - P1/2 | "50% of patients received ≥2 (range 1-4) prior ROS1 TKIs, of whom 93% had prior lorlatinib, repotrectinib, and/or taletrectinib. In this pivotal ROS1 TKI pre-treated data set, zidesamtinib demonstrated clinically meaningful activity and durability, including in patients with CNS disease and/or ROS1 G2032R-mutations, and/or in patients who had exhausted available options. Encouraging preliminary activity was also observed in TKI-naïve patients. Zidesamtinib's safety profile was consistent with its highly ROS1-selective, TRK-sparing design."

Clinical • Metastases • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Lung Cancer • Non Small Cell Lung Cancer • Pulmonary Disease • Solid Tumor • ROS1

Population-Adjusted Indirect Comparisons of Repotrectinib and Taletrectinib in ROS1+ aNSCLC [WITHDRAWN] (IASLC-WCLC 2025) - No abstract available

Clinical • Non Small Cell Lung Cancer • Solid Tumor • ROS1

TRUST-III: Phase 3 Head-To-Head Study of Taletrectinib vs Crizotinib in Patients With ROS1+ Non-Small Cell Lung Cancer (IASLC-WCLC 2025) - P3 | "In crizotinib- or entrectinib-pretreated patients, median DOR and PFS were 16.6 and 9.7 months, respectively. Key secondary endpoints include ORR; PFS per investigator; overall survival; safety and tolerability; and patient-reported outcomes of health-related quality of life. This trial is currently enrolling."

Clinical • Head-to-Head • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Updated Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: Phase 2 TRUST-I Study (IASLC-WCLC 2025) - P2, P3 | "2025; epub April 3, 2025). The efficacy and safety of taletrectinib will be directly compared with crizotinib in an ongoing randomized head-to-head phase 3 trial in TKI-naive patients with locally advanced or metastatic ROS1 + NSCLC (NCT06564324)."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

Clinical Pharmacologic Characteristics of Taletrectinib (IASLC-WCLC 2025) - "Drug-drug interactions should be considered with CYP3A modulators and PPIs. No clinically significant PK changes were observed across demographics or with mild hepatic impairment or mild-to-moderate renal impairment."

Clinical • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • Thoracic Cancer

Taletrectinib, a Next Generation Selective ROS1 Inhibitor, Exhibits a Differentiated Profile in ROS1 Fusion Models (IASLC-WCLC 2025) - P2 | "While FDA approved ROS1 inhibitors include crizotinib, entrectinib, and repotrectinib, patients are still in need of better treatment options that provide durable responses and prolonged progression-free survival (PFS), coupled with limited side effects. Conclusions : In summary, our nonclinical data demonstrate that, at clinically relevant concentrations, taletrectinib exhibits activity in ROS1 wild-type- and mutant-driven cancers, including intracranial models, while maintaining selectivity against TRKB, resulting in an overall favorable profile. An NDA, based on the results from the pivotal TRUST-I and TRUST-II studies, has been accepted with Priority Review by the U.S. FDA for the treatment of patients with advanced ROS1-positive NSCLC."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • NTRK2