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PO.CT01.04 · 临床试验

Taletrectinib in tyrosine kinase inhibitor (TKI)-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II

海报缩略图：Taletrectinib in tyrosine kinase inhibitor (TKI)-pretreated patients with ROS1+ non-small cell lung cancer (NSCLC): Updated data from TRUST-I and TRUST-II
编号 CT244 展板 9 时间 4/21 02:00–05:00 区域 Section 50 主讲 Geoffrey Liu, MD
分会场 Phase II Clinical Trials
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作者与单位

Geoffrey Liu1, Jorge Nieva2, Lyudmila Bazhenova3, Chang-Min Choi4, Qitao Yu5, Shunichi Sugawara6, Noriko Yanagitani7, Filippo de Braud8, Huijie Fan9, Enriqueta Felip10, Emilio Bria11, Maurice Pérol12, Feiwu Ran13, Wei Wang13, Xianyu Zhang13, Michael Chen13, Caicun Zhou14

1Princess Margaret Cancer Centre, Temerty School of Medicine, University of Toronto, Toronto, ON, Canada,2Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA,3Moores Cancer Center, University of California San Diego, San Diego, CA,4Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of,5Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China,6Sendai Kousei Hospital, Sendai, Japan,7Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan,8University of Milan, Milan, Italy,9The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China,10Vall d'Hebron University Hospital, Barcelona, Spain,11Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy,12Léon Bérard Cancer Center, Lyon, France,13Nuvation Bio Inc., New York, NY,14Shanghai East Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China

摘要 Abstract

Background: Taletrectinib is a next-generation, CNS-active, selective ROS1 TKI approved by the US FDA for the treatment of patients (pts) with locally advanced/metastatic ROS1+ NSCLC. In two Phase 2 studies, TRUST-I (NCT04395677) and TRUST-II (NCT04919811), taletrectinib showed robust efficacy, including intracranial (IC) activity and efficacy against G2032R mutations, and a tolerable safety profile in TKI-naïve and TKI-pretreated pts with ROS1+ NSCLC (Pérol M, et al. J Clin Oncol 2025). Here we report updated data in TKI-pretreated pts with ~3 years of follow-up. Methods: The study designs of TRUST-I and TRUST-II have been previously reported (Pérol M, et al. J Clin Oncol 2025). The efficacy population included pts from TRUST-I and TRUST-II with ≥1 measurable baseline lesion per RECIST v1.1 by independent review committee. The safety population included pts with ROS1+ NSCLC from Phase 1 and 2 studies who received ≥1 dose of taletrectinib 600 mg once daily. Results: As of Aug 31, 2025, the pooled efficacy analysis included 113 TKI-pretreated pts (66 from TRUST-I [prior crizotinib]; 47 from TRUST-II [37 prior crizotinib, 10 prior entrectinib]). With a median (m) follow-up of 35.8 months (mo), confirmed ORR was 55.8% (95% CI 46.1-65.1), mDOR was 16.6 mo (95% CI 10.7-24.9), mPFS was 9.7 mo (95% CI 7.6-12.0), and mOS was 29.8 mo (95% CI 23.2-46.0). Responses were observed in pts with G2032R mutations (8/13; ORR 61.5% [95% CI 31.6-86.1]) and with CNS metastases (IC-ORR 65.6% [95% CI 46.8-81.4]). Data by trial are shown in the Table. Safety was similar between TKI-pretreated pts and the safety population (n=363). Conclusion: With longer follow-up, taletrectinib maintained durable responses in TKI-pretreated pts, including activity against CNS metastases and G2032R mutations, with a tolerable safety profile. These data support taletrectinib as an effective and tolerable treatment option for pts with ROS1+ NSCLC after prior TKI therapy. Efficacy summary in TKI-pretreated pts. Efficacy All TKI-pretreated pts (N=113) TRUST-I (n=66) TRUST-II (n=47) Median follow-up, mo 35.8 45.2 30.5 cORR, % (95% CI) 55.8 (46.1-65.1) 51.5 (38.9-64.0) 61.7 (46.4-75.5) Median DOR, a mo (95% CI) 16.6 (10.7-24.9) 13.2 (7.7-24.8) 19.4 (10.7-NR) Median PFS, mo (95% CI) 9.7 (7.6-12.0) 7.6 (5.5-12.0) 11.8 (7.7-19.6) IC efficacy b (N=32) (n=16) (n=16) IC-ORR, % (95% CI) 65.6 (46.8-81.4) 75.0 (47.6-92.7) 56.3 (29.9-80.3) a DOR reported in responders only. b Assessed by IRC per mRECIST v1.1 in pts with ≥1 measurable baseline brain metastasis. c, confirmed; CI, confidence interval; DOR, duration of response; IC, intracranial; IRC, independent review committee; mo, months; mRECIST v1.1, modified Response Evaluation Criteria In Solid Tumors version 1.1; NR, not reached; ORR, objective response rate; PFS, progression-free survival; pts, patients; TKI, tyrosine kinase inhibitor.
利益披露 Disclosure
G. Liu, Nuvation Bio; Amgen; AstraZeneca; Takeda; Bayer; Boehringer Ingelheim; Gilead; EMD Serono Other, Grant/contract. J. Nieva, Genentech Other, Research Grant, Invited speaker, advisory board. AstraZeneca Other, Writing engagements, advisory board. Aadi Biosciences; ANP Technologies; BioAtla; BMS; Catalym; Daiichi Sankyo; Gilead; Kalivir; Sanofi; Pfizer; Takeda; Tubulis; Urogen Other, Advisory board. Affyimmune Other Business Ownership, Other, Board of Directors. Cansera Other Business Ownership, Other, Royalties. Indee Bio Other Business Ownership. Amgen; Johnson & Johnson; Novartis Stock. Merck Other, Research Grant. L. Bazhenova, JNJ; Revolution medicine; AbbVie; Eli Lilly; BMS; Pfizer; Nuvalent; Taiho Oncology; Summit; Bayer; Boerhinger Ingleheim; Genentech; Natera; Merck; Anheart Independent Contractor. C. Choi, None.. Q. Yu, None. S. Sugawara, AbbVie; Amgen; AnHeart; AstraZeneca; Bristol Myers Squibb; Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo, Delta-Fly Pharma; GSK; IQVIA; Merck Sharp & Dohme K.K.; Nippon Boehringer Ingelheim Other, Local PI. Novocure; Parexel International; PharmaMar; PPD-SNBL; Taiho Pharmaceutical Other, Local PI. Amgen; AstraZeneca; Bristol Myers Squibb; Chugai Pharmaceutical Co., Ltd.; Daiichi-Sankyo; Eisai; Kyowa Kirin; Lilly; Merck; Merck Sharp & Dohme K.K.; Nippon Boehringer Ingelheim; Nippon Kayaku Other, Lecture fee. Novartis; Ono Pharmaceutical Co., Ltd.; Pfizer; Sysmex; Taiho Pharmaceutical Co. Ltd.; Takeda; Thermo Fisher Scientific Other, Lecture fee. N. Yanagitani, AstraZeneca; Pfizer Japan; Ono Pharmaceuticals; Chugai Pharmaceutical Co., Ltd; Bristol-Myers Squibb; Daiichi Sankyo Company Limited; Eli Lilly Other, Payment or honoraria for lectures. F. de Braud, Pierre Fabre; Mattioli 1885; MCCann Health; MSD; IQVIA; Novartis; Indene; lncyte; Taiho Pharmaceutical; Menarini; Roche Other, Consulting. Sanofi; BMS; Taiho Pharmaceutical; Incyte Other, Advisory arrangements. AnHeart Therapeutics; Apollomics; AstraZeneca; Basilea Pharmaceutica; Bayer Healthcare; Boehringer lngelheim; BMS; F. Hoffmann-La Roche; lncyte; Itanet; Janssen-Cilag; Kymab; Loxo Oncology Other, P.I.. Medlmmune; Merck KGaA; Novartis; Tesaro Other, P.I.. Nadirex; ESO; Dephaforum; Ambrosetti; Motore Sanity; Effetti; Events; Fare Comunicazione; ltanet; Nadirex; BMS; Accmed; Idea-z; Dynamicom Education; Sanofi; AstraZeneca Other, Speakers' bureau. lncyte; BMS; Novartis; Sanofi; AstraZeneca Other, Traveling expenses. H. Fan, None. E. Felip, AbbVie; Amgen; AstraZeneca; Boehringer Ingelheim; Bristol Myers Squibb; Daichii Sankyo; Genentech/Roche; GlaxoSmithKline; Iteos Therapeutics; Janssen/Johnson & Johnson; Merck Sharp & Dohme Other, Consulting fees. Pierre Fabre; Pfizer; Pharmamar; Seagen; Regeneron; Tubulis; Moderna; Ellipses Pharma Other, Consulting fees. Amgen; Daiichi Sankyo; Eli Lilly; Roche/Genentech; Gilead; Janssen/Johnson & Johnson; Medical Trends; Medscape; Merck Sharp & Dohme; Peervoice; Pfizer Other, Speaker's bureau. AstraZeneca; Johnson & Johnson; Roche; Amgen Travel. Grifols Other, Independent member of the board. E. Bria, AstraZeneca; Roche Other, Grant/Contract. AstraZeneca; Roche; MSD; Takeda; Pierre-Farbre; Pfizer; Eli-Lilly; Amgen; Celltrion Other, Advisory board. M. Pérol, AstraZeneca; Pfizer; Amgen; Bristol-Myers Squibb; Novocure; Merck Sharp & Dohme; Sanofi; Pharmamar; Janssen; Ipsen Other, Invited speaker. AstraZeneca; Bristol-Myers Squibb; Amgen Other, Expert testimony. Eli Lilly; Pfizer; Merck Sharp & Dohme; Bristol-Myers Squibb; Novartis; AstraZeneca; Takeda; Sanofi; Amgen; AbbVie; Ipsen; Esaï; Daiichi Sankyo; Janssen; Novocure; Pharmamar Other, Advisory board. Eli Lilly, Merck Sharp & Dohme; Bristol-Myers Squibb; Amgen; AstraZeneca; AbbVie; Daiichi Sankyo; AnHeart Therapeutics; Nuvation Bio; Takeda; Roche Other, Principal investigator. AnHeart Therapeutics Other, Advisory role. F. Ran, Nuvation Bio Inc Employment, Stock. W. Wang, Nuvation Bio Inc Employment. X. Zhang, Nuvation Bio Inc Employment, Stock. M. Chen, Nuvation Bio Inc Employment. C. Zhou, None.

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