Updated Efficacy and Safety of Taletrectinib in Chinese Patients With ROS1+ Non-Small Cell Lung Cancer: Phase 2 TRUST-I Study
Wei Li,1 Anwen Xiong,1 Huijie Fan,2 Qitao Yu,3 Yanqiu Zhao,4 Yongsheng Wang,5 Xue Meng,6 Jingxun Wu,7 Yunpeng Liu,8 Xintian Qin,9 Kaihua Lu,10 Wu Zhuang,11 Yizhong Ren,12 Xiucui Li,12 Feiwu Ran,12 Caicun Zhou13
1Department of Medical Oncology, Shanghai Pulmonary Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China; 2The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China; 3Medical Oncology of Respiratory, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China; 4Henan Cancer Hospital, Zhengzhou, China; 5West China Hospital Sichuan University, Chengdu, China; 6Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China; 7The First Affiliated Hospital of Xiamen University, Xiamen, China; 8The First Hospital of China Medical University, Shenyang, China; 9The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, China; 10Jiangsu Province Hospital, Nanjing, China; 11Fujian Cancer Hospital, Fuzhou, China; 12Nuvation Bio, New York, NY, USA; 13Department of Medical Oncology, Shanghai East Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China
Presented at the World Conference on Lung Cancer | September 6–9, 2025 | Barcelona, Spain
For more information, please contact Dr Wei Li: leewluck@gmail.com
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Background
- Taletrectinib is a next-generation, CNS-active, selective, oral ROS1 inhibitor with efficacy against the G2032R resistance mutation1
- Taletrectinib is currently approved in China and the United States for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC2,3
- Taletrectinib demonstrated robust efficacy and favorable safety in patients with advanced or metastatic ROS1+ NSCLC from two Phase 2 studies: TRUST-I (NCT04395677) and TRUST-II (NCT04919811)4–6
- Here, we report updated efficacy data from the TRUST-I study, as well as safety data from an integrated safety analysis
Methods
- The TRUST-I study design has been previously published4
- Efficacy is reported for patients with ROS1+ NSCLC who started treatment on taletrectinib 600 mg QD from TRUST-I with 11 months of additional follow-up4
- An integrated safety analysis is also reported for patients with ROS1+ NSCLC who received ≥1 dose(s) of taletrectinib 600 mg in Phase 1 or Phase 2 trials
TRUST-I: Efficacy
Patient Demographics and Baseline Characteristics
aAssessed by IRC per mRECIST v1.1.
cORR by IRC According to RECIST v1.1
Data cutoff: October 28, 2024. aTwo patients with confirmed BOR of NE are not shown in the figure. bOne patient was excluded due to the presence of secondary cancer. One patient had a change of 136.5% which was cut at 100%. Six patients with confirmed BOR of NE are not shown in the figure.
aAssesed by IRC per mRECIST v1.1 in patients with ≥1 measurable baseline brain metastasis.
DOR and PFS in TKI-naïve Patients (n=103)
Median follow-up: 40.9 mo (range, 22.0–50.1).
DOR and PFS in Crizotinib-pretreated Patients (n=66)
Median follow-up: 35.1 mo (range, 21.5–50.1).
- Median OS was NR for TKI-naïve patients and 25.6 mo for crizotinib-pretreated patients
Integrated Safety Analysis (N=337)
- The integrated safety analysis includes 337 patients with ROS1+ NSCLC from two Phase 2 trials (TRUST-I and TRUST-II) and a Phase 1 trial (J102)
Overall Safety Summary (N=337)
Data cutoff: June 7, 2024. Longer follow-up was not available at time of analysis after completion of the J102 trial.
TEAEs of Clinical Interest (N=337)
aMedian time to onset for Grade ≥3 increased AST/ALT was 43 days (IQR: 22, 86) and median time to resolution was 13 days (IQR: 8, 19). These results are based on laboratory data.
Safety data from TRUST-I are available in the supplement, with no new safety signals identified with 11 months of additional follow-up
Conclusions
- In the TRUST-I study, taletrectinib continued to demonstrate meaningful efficacy in both TKI-naïve and crizotinib-pretreated patients with ROS1+ NSCLC
- High and durable response rates were observed, including high IC-ORR, efficacy against the G2032R resistance mutation, and encouraging PFS, regardless of line of therapy
- Taletrectinib demonstrated a favorable safety profile, with no new safety signals identified
- TEAEs of clinical interest, such as gastrointestinal events, increased AST/ALT, and dizziness, were largely transient and rarely led to treatment discontinuation
Supplement
TRUST-I: Baseline Characteristics
- Safety data reported here are for all patients from TRUST-I who received ≥1 dose(s) of taletrectinib
aAssessed by IRC per mRECIST v1.1.
TRUST-I Safety: TEAEs in ≥15% of Patients (N=173)a
Data cutoff: October 28, 2024. aSafety is reported for all patients who received ≥1 dose(s) of taletrectinib.
Abbreviations
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BOR, best overall response; c, confirmed; CI, confidence interval; CNS, central nervous system; COVID-19, coronavirus disease 2019; CR, complete response; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IC, intracranial; IQR, interquartile range; IRC, Independent Review Committee; mo, months; (m)RECIST v1.1, (modified) Response Evaluation Criteria in Solid Tumors version 1.1; NA, not available; NE, not evaluable; NR, not reached; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; QD, once daily; ROS1, ROS proto-oncogene 1; SD, stable disease; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event; TKI, tyrosine kinase inhibitor
References
- Katayama R, et al. Nat Commun 2019;10:3604
- IBTROZITM (taletrectinib). Prescribing Information 2025
- Nuvation Bio Receives Approval from China’s National Medical Products Administration for Taletrectinib for Patients with Advanced ROS1-positive Non-Small Cell Lung Cancer. Nuvation Bio. Accessed July 09, 2025. https://investors.nuvationbio.com/news/news-details/2025/Nuvation-Bio-Receives-Approval-from-Chinas-National-Medical-Products-Administration-for-Taletrectinib-for-Patients-with-Advanced-ROS1-positive-Non-Small-Cell-Lung-Cancer
- Li W, et al. J Clin Oncol 2024;42:2660–2670
- Liu G, et al. J Thorac Oncol 2024;19:S72–S73
- Pérol M, et al. J Clin Oncol 2025 43:1920–1929
Acknowledgments
- We would like to thank all patients who participated in this study, the study investigators, and their staff
- Due to retirement, Dr. Ziping Wang was unable to contribute to the development of this poster. We thank him for his earlier contributions to the study and the abstract associated with this publication
- This study was sponsored by Nuvation Bio Inc.
- Writing support was provided by Lisa Alberts, MPhil, of Ashfield MedComms, an Inizio company, and was funded by Nuvation Bio Inc.
