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

Updated Efficacy and Safety of Taletrectinib in Patients With ROS1+ Non-Small Cell Lung Cancer: The Global TRUST-II Study (IASLC-WCLC 2025) - P2, P3 | "Enrollment in TRUST-II is ongoing. 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 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ROS1

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

Updated Efficacy and Safety of Taletrectinib in Patients (pts) with ROS1+ Non-Small Cell Lung Cancer (NSCLC) (ELCC 2023) - P2 | "CRZ, crizotinib; DCR, disease control rate; NE, not evaluable; ORR, overall response rate; PFS, progression-free survival; TKI, tyrosine kinase inhibitor. Conclusions With additional follow-up, taletrectinib continued to demonstrate meaningful efficacy outcomes including high response rates, prolonged PFS, robust intracranial activity, activity against G2032R, and tolerable safety with low incidence of neurological AEs."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NTRK2 • ROS1

Nuvation Bio Announces New Analyses Reinforcing the Durable, Consistent Efficacy of IBTROZI (taletrectinib) Across Key Patient Subgroups in Advanced ROS1+ NSCLC at 2026 World Conference on Lung Cancer (PRNewswire) - "Long-term pooled data from the pivotal TRUST-I and TRUST-II studies showed similar efficacy, including duration of response and progression-free survival, between CD74 and non-CD74 ROS1 fusion-partner subgroups...Among TKI-naïve patients: ORR was 90.0% in those with prior chemotherapy (n=30) and 89.8% in those with no prior chemotherapy (n=127); Median DOR was 48.3 months and 54.3 months, respectively....Among TKI-naïve patients: ORR was 89.5% in those with CD74 fusions (n=19) and 88.9% in those with non-CD74 fusions (n=18); Median DOR was comparable between the two groups at 44.8 and 43.3 months, respectively, as was median progression-free survival (PFS) at 46.1 and 44.6 months....With long-term follow-up, IBTROZI continued to demonstrate a manageable safety profile consistent with previous reports, with no new safety signals identified."

P2 data • Non Small Cell Lung Cancer

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 (ESMO 2026) - No abstract available

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

Taletrectinib Across Key Subgroups in Patients With ROS1+ Non-Small Cell Lung Cancer: Results From TRUST-I and TRUST-II (IASLC-WCLC 2026) - P2 | "Conclusions : With ~3 years of follow-up, taletrectinib demonstrated high and durable response rates in both TKI-naïve and TKI-pretreated patients with ROS1+ NSCLC, with a manageable safety profile. Subgroup analyses demonstrated similar efficacy regardless of prior chemotherapy exposure or ROS1 fusion partners."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD74 • ROS1

Efficacy and safety of taletrectinib in patients with advanced or metastatic ROS1+ non–small cell lung cancer: The phase 2 TRUST-I study. (ASCO 2024) - P2 | "With longer follow-up, taletrectinib continues to show high and durable overall responses, robust intracranial and G2032R activity, and a favorable safety profile with a low incidence of neurologic AEs. An additional ongoing pivotal phase 2 study, TRUST-II (NCT04919811), is further evaluating the efficacy and safety of taletrectinib in patients in the US, Europe, and Asia."

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

Efficacy and Safety of Taletrectinib in Patients with ROS1+ Non-Small Cell Lung Cancer: The Global TRUST-II Study (IASLC-WCLC 2024) - P2 | "In TKI-pretreated patients, 82% received prior crizotinib and 18% received prior entrectinib. With increased enrollment and longer follow-up in a geographically diverse population, taletrectinib continues to demonstrate high and durable overall responses, robust IC activity, and a favorable safety profile with low incidence of neurologic AEs in TKI-naive and TKI-pretreated patients with ROS1+ NSCLC. The efficacy and safety of taletrectinib in TRUST-II remains highly consistent with TRUST-I."

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

Nuvation Bio Inc…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 (PRNewswire) - "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...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."

FDA approval • Non Small Cell Lung Cancer

Taletrectinib in tyrosine kinase inhibitor (TKI)-naïve patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II (AACR 2026) - P2 | "With ~3 years of follow-up in the pooled analysis and >4 years of follow-up in TRUST-I, taletrectinib demonstrated high and durable response rates in TKI-naïve pts with ROS1+ NSCLC, with a mDOR of >4 years. To the best of our knowledge, these results represent the highest ORR and longest DOR and PFS reported to date for an FDA-approved ROS1 TKI in this patient population. These data support taletrectinib as an effective and tolerable treatment option particularly in pts with advanced ROS1+ NSCLC who have not received a prior ROS1 TKI."

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

Taletrectinib in ROS1+ Non-Small Cell Lung Cancer: TRUST. (PubMed, J Clin Oncol) - "Taletrectinib showed a high response rate with durable responses, robust IC activity, prolonged PFS, favorable safety, and low rates of neurologic adverse events in TKI-naïve and pretreated patients."

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

Efficacy and safety of taletrectinib in patients (Pts) with ROS1+ non-small cell lung cancer (NSCLC): Interim analysis of global TRUST-II study (ESMO 2023) - P2 | "No treatment-related AE (TRAE) led to discontinuation or death; 24% of pts had a TRAE leading to dose reduction. Conclusions In this ongoing global pivotal phase 2 study, taletrectinib demonstrated robust and consistent clinical activity with TRUST-I, including high response rates and a tolerable safety profile in both TKI-naive and TKI-pretreated pts with ROS1+ NSCLC."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NTRK2 • ROS1

Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: The Phase II TRUST-I Study. (PubMed, J Clin Oncol) - P2 | "Taletrectinib continues to show high and durable overall responses, prolonged PFS, robust activity against intracranial lesions and acquired resistance mutations including G2032R, and a favorable safety profile with a low incidence of neurologic TEAEs."

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

Taletrectinib vs crizotinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC): A matching-adjusted indirect comparison (MAIC) (ELCC 2025) - P2 | "The incidence of grade 3 TRAEs was comparable between taletrectinib and crizotinib (45% [95% CI: 31.2%, 59.8%] vs 36% [95% CI: 23.1%, 50.2%], respectively). Conclusions In this cross-trial MAIC analysis, taletrectinib showed significantly improved outcomes compared with crizotinib in TKI-naive patients with ROS1+ NSCLC, including higher ORR, a significant reduction in the risk of disease progression and mortality, and with comparable grade 3 TRAEs"

Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • ROS1

TRUST-II: a global phase II study of taletrectinib in ROS1-positive non-small-cell lung cancer and other solid tumors. (PubMed, Future Oncol) - "Crizotinib and entrectinib have been approved to treat ROS1 fusion-positive (ROS1) non-small-cell lung cancer. Secondary end points include duration of response, progression-free survival, overall survival and safety. This trial is enrolling patients in North America, Europe and Asia."

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

Safety and preliminary clinical activity of NVL-520, a highly selective ROS1 inhibitor, in patients with advanced ROS1 fusion-positive solid tumors (AACR-NCI-EORTC 2022) - P1/2 | "Rationally designed ROS1 tyrosine kinase inhibitors (TKIs) that surpass the limitations of FDA/EMA-approved (crizotinib/entrectinib) or other investigational agents are a medical need. The novel ROS1 TKI NVL-520 is highly selective and designed to avoid the neurologic toxicities associated with ROS1 TKIs that concurrently inhibit TRK (entrectinib/repotrectinib/taletrectinib)...Patients received a median of 3 (range: 1-9) prior anticancer therapies, including any ROS1 TKI (100%); investigational ROS1 TKI (85%, including lorlatinib in 55%, repotrectinib in 40%); ≥2 ROS1 TKIs (75%); any chemotherapy (80%); ≥2 lines of chemotherapy (50%)... NVL-520 has been well-tolerated up to 100 mg daily with favorable pharmacokinetics. Activity has been demonstrated in heavily pretreated patients (of whom 70% received ≥2 prior ROS1 TKIs plus chemotherapy), including those with brain metastases and the G2032R mutation."

Clinical • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • 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

Zidesamtinib in patients with ROS1+ NSCLC previously treated with repotrectinib or taletrectinib (AACR 2026) - P1/2 | "The meaningful clinical activity presented here for zidesamtinib, including in pts with CNS disease and ROS1 G2032R resistance mutation, indicates that many ROS1+ NSCLCs remain ROS1-dependent beyond repotrectinib and taletrectinib."

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

Nuvation Bio Inc…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 12–15, 2026, in Seoul, South Korea, and at the European Society of Medical Oncology Congress (ESMO) October 23–27, 2026 (PRNewswire) - "These findings from the pivotal Phase 2 studies will feature the efficacy and safety of IBTROZI (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."

P2 data • Non Small Cell Lung Cancer

Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Nuvation Bio Inc.

New P1 trial

Comparative efficacy of taletrectinib versus first-generation TKIs in TKI-naïve ROS1+ non-small cell lung cancer: A matching-adjusted indirect comparison. (PubMed, Lung Cancer) - P2 | "In this analysis, taletrectinib was associated with more favorable response and survival outcomes compared with crizotinib or entrectinib in TKI-naïve patients with ROS1+ NSCLC after adjustment for baseline characteristics, supporting taletrectinib as an effective treatment option in this patient population."

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

Intracranial Efficacy of Crizotinib and Postprogression Therapeutic Strategies in Advanced c-ros Oncogene 1 (ROS1)-Positive Non-Small Cell Lung Cancer (NSCLC), a Multicenter Real-World Study. (PubMed, MedComm (2020)) - "After progression, next-generation ROS1 inhibitors (active against the G2032R resistance mutation, for example, taletrectinib and repotrectinib) significantly prolonged PFS compared to older-generation targeted agents (median 13.9 vs. 4.4 months), especially among patients with secondary ROS1 resistance mutations (ORR 66.7% vs. 14.3%). In our cohort, lorlatinib demonstrated superior efficacy to entrectinib, with a trend toward longer PFS and higher overall (34% vs. 7%) and intracranial (50% vs. 0%) response rates. This large real-world study confirms crizotinib's intracranial benefit and underscores the importance of next-generation ROS1 inhibitors and older-generation agents like lorlatinib-for improved patient outcomes after crizotinib resistance."

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

Serial ROS1 Inhibition Achieves Long-Term Disease Control in a H3K27M-Mutant Glioma: A Case Report (ISPNO 2026) - P1/2 | "Given the patient's age and the unusual presentation of off-midline multifocal disease, with an actionable alteration, alternative therapy to radiation was explored.She enrolled on the STARTRK trial (NCT02650401) and was treated with entrectinib for 2 years, achieving a partial response with complete resolution of several lesions.Her course on therapy was complicated by significant adverse effects, including fractures and weight gain that eventually led to treatment discontinuation. Twelve months later, her disease progressed with the appearance of new enhancing lesions and she was started on lorlatinib, a selective ALK/ROS1 inhibitor...She was then started on taletrectinib, a highly selective ROS1 tyrosine kinase inhibitor, which she is tolerating without treatment-limiting toxicity and with good radiographic response. She is now eight years from diagnosis with ongoing clinical benefit from ROS-1 inhibition. Conclusion This report highlights the biological..."

Case report • Clinical • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Disorders • Diffuse Midline Glioma • Epilepsy • Glioma • Musculoskeletal Diseases • Orthopedics • Solid Tumor • ALK

Eisai…announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) (Eisai Press Release) - "The application was submitted through the International Recognition Pathway, which takes into account approvals from trusted regulatory partners and supports expedited access to medicines in the UK. The application will now be evaluated by the MHRA to decide whether to approve or reject the application....Additional filings are planned for Canada and other regions included in Eisai’s licensed territories....The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally."

MHRA filing • Non Small Cell Lung Cancer

Phase 3 Study of Taletrectinib vs Placebo as an Adjuvant Therapy in ROS1 Positive NSCLC (TRUST-IV) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Nuvation Bio Inc.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor