Efficacy of Taletrectinib (AB-106/DS-6051b) in ROS1+ NSCLC: An Updated Pooled Analysis of U.S. and Japan Phase 1 Studies
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Introduction Taletrectinib (AB-106/DS-6051b) is an oral, potent selective ROS1 and pan-NTRK tyrosine kinase inhibitor (TKI). Preclinically, taletrectinib has activity against ROS1 G2032R solvent-front mutation. Methods Patients with ROS1+ NSCLC enrolled into two phase 1 studies conducted in United States (U101, NCT02279433) and Japan (J102, NCT02675491) were analyzed for objective response rate (ORR) by the Response Evaluation Criteria in Solid Tumors version 1.1, progression-free survival, and safety. Results A total of 22 patients with ROS1+ NSCLC out of the total 61 patients enrolled were analyzed. Taletrectinib was given at the oral dose of 400 mg, 600 mg, 800 mg, and 1200 mg once daily and 400 mg twice daily as part of the dose-escalation schema. Data cutoff was August 19, 2020. Median follow-up time for all 22 patients was 14.9 months (95% confidence interval [CI]: 4.1–33.8). A total of 18 patients with ROS1+ were assessable for response. The confirmed ORR for ROS1 TKI-naive patients (N = 9) was 66.7% (95% CI: 35.4–87.9) with a disease control rate of 100% (70.1–100). The confirmed ORR for crizotinib pretreated patients (N = 6) was 33.3% (95% CI: 9.7–70.0) with a disease control rate of 88.3% (95% CI: 443.6–97.0). The median progression-free survival for ROS1 TKI-naive patients (N = 11) was 29.1 months (95% CI: 2.6–not reached) and 14.2 months (95% CI: 1.5–not reached) for crizotinib-refractory only patients (N = 8). The most common treatment-related adverse events were alanine transaminase elevations (72.7%), aspartate transaminase elevations (72.7%), nausea (50.0%), and diarrhea (50.0%). Grade 3 or higher adverse events were alanine transaminase elevations (18.2%), aspartate transaminase (9.1%), and diarrhea (4.5%). Conclusions Taletrectinib (AB106/DS6051b) has a meaningful clinical activity in patients with advanced ROS1+ NSCLC who are ROS1 TKI-naive or crizotinib-refractory and a manageable safety profile.
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The recommended phase II dose of taletrectinib is 600 mg once daily.
“The recommended phase II dose (600 mg once daily) was established in two phase I trials conducted in the United States and Japan21,22 and confirmed during the safety lead-in of TRUST-I.20”
From Taletrectinib in <i>ROS1</i> + Non–Small Cell Lung Cancer: TRUST (2025) · cites this paper as [22]
Overall, taletrectinib demonstrated a favorable tolerability and safety profile in patients with advanced ROS1+ NSCLC and other solid tumors treated at 600 mg once daily (N=352).
“Overall, taletrectinib demonstrated a favorable tolerability and safety profile in patients with advanced ROS1+ NSCLC and other solid tumors treated at 600 mg once daily (N = 352).22”
From Taletrectinib in <i>ROS1</i> + Non–Small Cell Lung Cancer: TRUST (2025) · cites this paper as [22]
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- Authors
- Ou, S.-H. I., Fujiwara, Y., Shaw, A. T., Yamamoto, N., Nakagawa, K., Fan, F., Hao, Y., Gao, Y., Jänne, P. A., & Seto, T.
- Affiliations
- University of California, Irvine (US)
- National Cancer Center Hospital (JP)
- Harvard University (US)
- Kindai University (JP)
- National Hospital Organization Kyushu Cancer Center (JP)
- Corresponding author
- Ou, Sai-Hong Ignatius
- ORCID
- Venue
- JTO Clinical and Research Reports
- Publisher
- Elsevier BV
- Published
- 2021-01
- Volume
- 2
- Issue
- 1
- Pages
- 100108
- ISSN
- 2666-3643 (ISSN-L)
- PMC
- PMC8474193
- OpenAlex
- W3094439638
- Cited by
- 40
- References
- 14
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 6 · 2023: 11 · 2022: 10 · 2021: 5
- FWCI
- 3.66
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- JTO Clinical and Research Reports (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Genentech
- Chugai Pharmaceutical
- GlaxoSmithKline
- Bayer Fund
- Merck
- Parexel
- Novartis
- Kyowa Hakko Kirin
- Merck Sharp and Dohme
- Astellas Pharma
- AstraZeneca
- Taiho Pharmaceutical
- Ono Pharmaceutical
- Bristol-Myers Squibb
- AbbVie
- Daiichi-Sankyo
- Eli Lilly and Company
- Meso Scale Diagnostics
- Eisai
- Pfizer
- Takeda Pharmaceuticals U.S.A.
- Astellas Pharma US
- Nichi-Iko Pharmaceutical
- Roche
- Boehringer Ingelheim Japan
- Boehringer Ingelheim
- Sanofi
- Otsuka America
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- ROS1-positive non-small cell lung cancer, ROS1 tyrosine kinase inhibitors, NTRK inhibitors, objective response rate, progression-free survival, drug safety, dose escalation, oral tyrosine kinase inhibitor, first-line therapy, second-line therapy
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