PO.CT01.04 · 临床试验

Zidesamtinib in patients with ROS1 + NSCLC previously treated with repotrectinib or taletrectinib

编号 CT248 展板 13 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, Alexander E. Drilon², Benjamin Besse³, Gianluca Spitaleri⁴, Jessica J. Lin⁵, Byoung Chul Cho⁶, Tatsuya Yoshida⁷, Daniel Haggstrom⁸, Steven Kao⁹, Aurelie Swalduz¹⁰, Misako Nagasaka¹¹, Benjamin J. Solomon¹², Lorenza Landi¹³, Chiara Bennati¹⁴, Elvire Pons-Tostivint¹⁵, Christophe Dooms¹⁶, A. J. van der Wekken¹⁷, Saiama Waqar¹⁸, Shirish Gadgeel¹⁹, Chia-Chi Lin²⁰, Tetsuro Kondo²¹, Hidetoshi Hayashi²², Daniel Tan²³, Giulia Pasello²⁴, Matteo Duca²⁵, Luis G. Paz-Ares²⁶, Antonio Calles²⁷, Enriqueta Felip²⁸, Julien Mazieres²⁹, Adrianus Johannes de Langen³⁰, Alice T. Shaw³¹, Jonathan W. Riess³², Marina Garassino³³, Elaine Shum³⁴, Christina S. Baik³⁵, Jessica R. Bauman³⁶, D. Ross Camidge³⁷, Chien-Chung Lin³⁸, Gee-Chen Chang³⁹, Dong-Wan Kim⁴⁰, Myung-Ju Ahn⁴¹, Ji-Youn Han⁴², Kiichiro Ninomiya⁴³, Ryo Ariyasu⁴⁴, Ross Andrew Soo⁴⁵, Sanjay Popat⁴⁶, Jürgen Wolf⁴⁷, Maria Rosario García Campelo⁴⁸, Vivek A. Upadhyay⁴⁹, Stephen V. Liu⁵⁰

¹Princess Margaret Hospital, Toronto, ON, Canada,²Memorial Sloan Kettering Cancer Center and Weill Cornell Medical Center, New York, NY,³Paris Saclay University, Gustave Roussy, Villejuif, France,⁴Division of Thoracic Oncology Istituto Europeo di Oncologia, Milan, Italy,⁵Mass General Brigham Cancer Institute, Boston, MA,⁶Yonsei Cancer Center, Seoul, Korea, Republic of,⁷National Cancer Center Hospital, Tokyo, Japan,⁸Levine Cancer, Atrium Health, Charlotte, NC,⁹Chris O'Brien Lifehouse, Camperdown, Australia,¹⁰Centre Léon Bérard, Lyon, France,¹¹University of California Irvine Medical Center, Orange, CA,¹²Peter MacCallum Cancer Centre, Melbourne, Australia,¹³Istituto Nazionale Tumori Regina Elena, IRCCS, Rome, Italy,¹⁴Ospedale Santa Maria Delle Croci, Ravenna, Italy,¹⁵Department of Medical Oncology, University Hospital of Nantes, Nantes, France,¹⁶Department of Respiratory Diseases, University Hospitals Leuven, Leuven, Belgium,¹⁷Department of Pulmonology and Tuberculosis, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands,¹⁸Washington University School of Medicine, St. Louis, MO,¹⁹Henry Ford Cancer Center, Detroit, MI,²⁰National Taiwan University Hospital, Taipei, Taiwan,²¹Kanagawa Cancer Center, Yokohama, Japan,²²Kindai University Hospital, Osaka, Japan,²³National Cancer Centre Singapore, Singapore, Singapore,²⁴Oncologia 2 Istituto Oncologico Veneto IRCCS and Department of Surgery Oncology and Gastroenterology, Padova, Italy,²⁵Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy,²⁶Hospital Universitario 12 de Octubre, Madrid, Spain,²⁷Medical Oncology Department. Hospital General Universitario Gregorio Marañón, Madrid, Spain,²⁸Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain,²⁹Institut Claudius Rigaud, Toulouse, France,³⁰Department of Thoracic Oncology, Antoni van Leeuwenhoek Hospital - Netherlands Cancer Institute, Amsterdam, Netherlands,³¹Dana-Farber Cancer Institute, Boston, MA,³²University of California Davis, Davis Comprehensive Cancer Center, Sacramento, CA,³³University of Chicago, Chicago, IL,³⁴New York University Perlmutter Cancer Center, New York, NY,³⁵Fred Hutchinson Cancer Center, Seattle, WA,³⁶Fox Chase Cancer Center, Philadelphia, PA,³⁷University of Colorado Cancer Center, Aurora, CO,³⁸National Cheng Kung University Hospital and Tainan Hospital, Ministry of Health & Welfare, Tainan, Taiwan,³⁹Chung Shan Medical University Hospital, Taichung, Taiwan,⁴⁰Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea, Republic of,⁴¹Section of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of,⁴²National Cancer Center, Tokyo, Japan,⁴³Okayama University Hospital, Okayama, Japan,⁴⁴Japanese Foundation for Cancer Research, Tokyo, Japan,⁴⁵National University Hospital, Singapore, Singapore,⁴⁶Lung Unit, Royal Marsden Hospital, London, United Kingdom,⁴⁷Cologne University Hospital, Köln, Germany,⁴⁸University Hospital A Coruña, CHUAC, A Coruña, Spain,⁴⁹Nuvalent, Inc., Cambridge, MA,⁵⁰Georgetown Lombardi Comprehensive Cancer Center, Washington, DC

摘要 Abstract

Introduction: Preclinical data indicates that the investigational ROS1 TKI zidesamtinib offers improved potency against ROS1, including ROS1 G2032R resistance mutation, brain penetrance and TRK selectivity over FDA-approved dual TRK/ROS1 TKIs repotrectinib and taletrectinib. Maximizing ROS1 activity in the clinical setting, including activity in the CNS, is essential to drive clinically meaningful responses to treatment. ARROS-1 is evaluating zidesamtinib in patients (pts) with advanced/metastatic ROS1 + NSCLC and other solid tumors. Here we report data in pts with NSCLC previously treated with repotrectinib or taletrectinib. Methods: Key study endpoints in the global, single arm, phase 1/2 ARROS-1 trial (NCT05118789) include objective response rate (ORR, RECIST v1.1 by BICR), duration of response (DOR), intracranial ORR (IC-ORR), and safety. This efficacy analysis included repotrectinib or taletrectinib previously-treated pts with ROS1 + NSCLC and measurable disease by BICR, treated with zidesamtinib 100 mg QD. Data cut-off: 22 Sep 2025. Results: At baseline, efficacy evaluable pts (results in Table) with prior repotrectinib (n=46) or taletrectinib (n=19) received a median of 2 prior ROS1 TKIs (range 1-4 for either) and 3 prior anticancer therapies (range 1-7 and 1-6, respectively); 63% and 53% received prior chemo. ROS1 resistance mutations by local or central testing were reported in 35% and 42%; active CNS disease in 46% and 53%. Efficacy Parameter (RECIST v1.1, BICR) Prior repotrectinib ± chemo Prior taletrectinib ± chemo ORR % (n/n) [95% CI] 41% (19/46) a [27, 57] 47% (9/19) [24, 71] CR n (%) 3 (7%) a 1 (5%) mDOR, m b [95% CI] 15.7 [5.6, NE] NR [5.2, NE] ROS1 G2032R resistance mutation ORR % (n/n) [95% CI] 67% (8/12) [35, 90] 50% (2/4) c [7, 93] CR n (%) 1 (8%) 0 mDOR, m b [95% CI] 15.7 [3.5, NE] NR [NE, NE] Intracranial Activity d IC-ORR % (n/n) [95% CI] 44% (8/18) [22, 69] 71% (5/7) [29, 96] IC-CR n (%) 2 (11%) 3 (43%) mIC-DOR, m b [95% CI] NR [5.2, NE] NR [5.2, NE] BICR, blinded independent central review; CI, confidence interval; CR, complete response; IC, intracranial; m, months; mDOR, median DOR; NE, not estimable; NR, not reached; ORR, objective response rate; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1. a 1 response pending confirmation. b Kaplan-Meier estimates. c Responses also observed in pts with ROS1 D2033N (n=1) and L2086F (n=1). d Includes pts with measurable (≥5mm) CNS lesions. The safety profiles in these pt groups were consistent with what was previously reported in the overall pivotal TKI pretreated study population, including the avoidance of TRK or neurological adverse events (Drilon AE, et al. J Thorac Oncol. 2025;20(10)(Suppl 3):S3). Conclusions: 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.

利益披露 Disclosure

G. Liu, Pfizer Other, Advisory role, Speakers' Bureau, Honoraria. Novartis Other, Advisory role, Honoraria. Astrazeneca ), Advisory role, Speakers' bureau, honoraria. MedImmune ), Advisory role. Takeda ), Other, Advisory role, Speakers' bureau, honoraria. Roche Canada Other, Advisory role, honoraria. Merck Other, Honoraria. Abbvie Other, Honoraria. Bayer Other, Honoraria. Bristol-Meyers Squibb Other, Honoraria. Jazz Pharmaceuticals Other, Honoraria. Amgen Other, Honoraria. Nuvation Bio Other, Honoraria. EMB Serono Other, Honoraria. Roche ). Boehringer Ingelheim ). A. E. Drilon, mBRACE; Treeline Stock. MonteRosa; Innocare; Boundless Bio; Treeline; Nuvalent; 14ner/Elevation Oncology; Entos; Prelude; Bayer; Applied Pharmaceutical Science; Bristol Myers Squibb; Enlaza; Pfizer; Roche/Genentech Other, Consulting or advisory role. Novartis; Two River; Lilly/Loxo; Abbvie; Amgen; Helsinn; AnHeart Therapeutics Consulting or advisory role. Foundation Medicine; Teva; Taiho; GlaxSmithKlein; PharmaMar ). Wolters Kluwer; UpToDate; Selpercatinib-Osimertinib (US 18/041,617, pending) Patent, Copyright, Other Intellectual Property. Boehringer Ingelheim; Merck Puma Travel. B. Besse, Abbvie; BioNTech SE; Beijing Avistone Biotechnology; Bristol-Myer Sqibb; Cure Vac AG; PharmaMar; Regeneron; Sanofi Aventis; Eli Lilly; Ellipses Pharma Ltd; F. Hoffman-La Roche Ltd Other, Advisory role. Foghorn Therapeutics; Genmab; Immunocore; Owkin Other, Advisory role. AstraZeneca; Amgen; Beigene; CureVac AG; GENMAB A/S; Janssen; MSD; Ose Immunotherapeutics; PharmaMar; Sanofi; Takeda Other, Steering Committee. Abbvie; AstraZeneca; Bristol-Myer Sqibb; Daiichi Sankyo; Lilly; MSD; Ose Immunotherapeutics; Sanofi Aventis; Servier Other, Speaker. G. Spitaleri, Takeda Other, Advisory role. J. J. Lin, Genentech; Nuvalent; Turning Point Therapeutics; Bayer; Mirati Therapeutics; Novartis; Elevation Oncology; Regeneron; Merus; Yuhan; Daiichi Sankyo/AstraZeneca; Bristol-Myers Squibb; AstraZeneca Other, Consulting, advisory. Ellipses Pharma; CLaiM Therapeutics; Anheart Therapeutics; Pfizer; Takeda; Hyku Biosciences; Lilly; Roche/Genentech; Nuvation Bio; Janssen; Gilead Sciences; Triana; Nuvectis Pharma Other, Consulting, advisory. Pfizer; Merus; Takeda; Briston-Myers Squibb Travel. Turning Point Therapeutics; Novartis; Relay Therapeutics; Elevation Oncology; Bayer; Roche; Linnaeus Therapeutics; Nuvalent; Pfizer; Bristol-Myers Squibb; Sutro Biopharma; Summit Therapeutics ). Lilly; Bicycle Therapeutics; Genentech ). OncLive; PeerView; Curio Science; HMP Education; Medscape; Answers in CME; TotalCME; Clinical Care Options Other, Honoraria. B. Cho, Yonsei University Health System Employment. 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Hoffman-La Roche AG; Boehringer Ingelheim; Pfizer; Merck; Chugai Pharma Other, Speakers' Bureau. G. Chang, AstraZeneca; Novartis; Pfizer; Boehringer Ingelheim; F. Hoffman-La Roche, Ltd; Eli Lilly and Company Oncology; MSD; Takeda; Amgen; Bristol-Myers Squibb; Ono Pharma Taiwan Co. Ltd; Daiichi Sankyo Other, Honoraria. D. Kim, Amgen; AstraZeneca; GlaxoSmithKline; Johnson & Johnson/Janssen; Merck; MSD; Boehringer Ingelheim; BridgeBio Therapeutics; Daiichi Sankyo; Bristol-Myers Squibb; Chong Keun Dang; IMBdx; Merus NV Other. Mirati Therapeutics; Merck; Novartis; Pfizer; Roche/Genentech; Takeda; Yuhan; Zymeworks Other. Alpha Biopharma; AstraZeneca/MedImmune; Hanmi; Janssen; Merus; Mirati Therapeutics; MSD; Novartis; Ono Pharmaceutical; Pfizer; Roche/Genentech; Takeda; TP Therapeutics; Xcovery; Yuhan ). Boehringer Ingelheim; Amgen; Daiichi Sankyo; Chong Kun Dang Pharmaceutical; BridgeBio Pharma; GlaxoSmithKline; Merck; inno.N; IMBdx; Zymeworks ). M. Ahn, AstraZeneca; MSD; Takeda; Amgen; Merck Serono; Pfizer; Yuhan; Daiichi Sankyo/AstraZeneca; Genexine; Voronoi Health Analytics; Boehringer Ingelheim Other, Advisory role. AstraZeneca; MSD; Takeda; Amgen; Merck Serono; Yuhan; Daiichi Sankyo/AstraZeneca; Boehringer Ingelheim Other, Honoraria. J. Han, Johnon & Johnson Other, Honoraria, Speakers' Bureau. Pfizer ), Other, Honoraria, consulting. Merck Other, Honoraria, consulting. AstraZeneca Other, Consulting, Speakers' Bureau. Boehringer Ingelheim Other, Consulting. Amgen Other, Consulting. Abbvie Other, Consulting. Daiichi Sankyo Other, Consulting, Speakers' Bureau. Daewoong, Other, Consulting. Roche Other, Consulting. Speakers' Bureau. Yuhan Other, Speakers' Bureau. K. Ninomiya, MSD KK; Chugai Pharmaceutical; Ono Pharmaceutical; Lilly Japan; Bristol Myers Squibb; Nippon Kayaku; AstraZeneca; Daiichi-Sankyo; Takeda Pharmaceutical; Taiho Pharmaceutical; Amgen; Kyowa Kirin Other, Honoraria. Janssen Pharmaceutical Other, Honoraria. R. Ariyasu, Astra Zeneca; Chugai Pharmaceutical; MSD; ONO Pharmaceutical; Bristol Myers Squib Other, Honoraria. R. Soo, AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Novartis; Pfizer; Roche/Genentech; Taiho Pharmaceutical; Yuhan; Takeda; Amgen; Lilly; Merck; Janssen; Puma Biotechnology; Merck Serono; Bayer Other, Advisory role. Thermo Fisher Scientific; J INTS BIO; Anheart Therapeutics; Daiichi Sankyo/AstraZeneca; GlaxoSmithKline; Sanofi Other, Advisory role. AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Lilly; Novartis; Pfizer; Roche/Genentech; Takeda; Yuhan; Amgen; Bayer; Merck; Merck Serono; Puma Biotechnology; J INST BIO; Agilent; Genmab Other, Honoraria. Anheart Theraepeutics; Daiichi Sankyo/AstraZeneca; Johnson & Johnson/Janssen; Novartis; Sanofi; Abbvie; Taiho Onoclogy; Takeda; Thermo Fisher Scientific; Chugal Pharma Other, Honoraria. AstraZeneca; Boehringer Ingelheim; Pfizer ). S. Popat, Boehringer Ingelheim; Roche; Pfizer; AstraZeneca; Bristol-Myers Squibb; MSD; Guardant Health; Takeda; Bayer; Daiichi Sankyo; Janssen; GlaxoSmithKline; Lilly; Merck KGaA; Amgen; Pfizer; Pierre Fabre Other, Advisory role. Anheart Therapeutics; Arcus Biosciences; Ellipses Pharma; Erasca, Inc; Gilead Sciences; PharmaMar; BioNTech; Genmab; IO Biotech; Nuvalent; Servier; Other, Advisory role. Summit Therapeutics; Taiho Oncology; Bicycle Therapeutics Other, Advisory role. Roche/Genentech; Gilead Biosciences Travel. Boehringer Ingelheim; Epizyme; Bristol-Myers Squibb; Clovis Oncology; Roche; Lilly; Takeda; Celgene; Novartis; ARIAD; MSD; Daiichi Sankyo; Guardant Health; Janssen; GlaxoSmithKline ). Mirati Therapeutics; Trizell; Turning Point Therapeutics; Amgen; AstraZeneca ). J. Wolf, Abbvie; AstraZeneca; Bristol-Myers Squibb; Boehringer Ingelheim; Ignyta; Lilly; Novartis; Pfizer; Roche; Janssen; Loxo/Lilly; Blueprint Medicines; Amgen; Takeda; Bayer; Daiichi Sankyo Europe GmbH Other, Advisory role. Seagen; Nuvalent; Merck; Mirati Therapeutics Other, Advisory role. AstraZeneca; Amgen; Janssen; Mirati Therapeutics; Novartis; Pfizer; Merck; Sanofi; Intellisphere Travel. Abbvie; AstraZeneca; Bristol-Myers Squibb; Boehringer Ingelheim; MSD; Novartis; Roche; Amgen; Bayer; Blueprint Medicines; Daiichi Sankyo Europe GmbH; Janssen; Lilly; Pfizer; Seagen; Takeda; Nuvalent Other, Honoraria. Mirati Therapeutics; Merck; Amgen Astellas BioPharma; BeiGene; DISCO Pharmaceuticals; Ellipses Pharma; Regeneron; Genmab; Zuelling Pharma; Turning Point Therapeutics; Revolution Medicines Other, Honoraria. Kingyee Beiging Co LTD; Nuvation Bio Other, Honoraria. Bristol-Myers Squibb; Novartis; Pfizer; Janssen; AstraZeneca ). M. García Campelo, AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Janssen Oncology; MSD Oncology; Novartis; Pfizer; Roche/Genentech; Takeda Other, Advisory role. Amgen; AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Janssen Oncology; Eli Lilly; MSD Oncology; Novartis; Pfizer; Roche; Sanofi/Aventis; Takeda; MSD Oncology Other, Speakers' Bureau. V. A. Upadhyay, Nuvalent, Inc. Employment, Stock, Stock Option. S. V. Liu, Genentech; Bristol-Myers Squibb; AstraZeneca; Takeda; Regeneron; Guardant Health; MSD Oncology; Jazz Pharmaceuticals; Daiichi Sankyo/UCB Japan; Novartis; Gilead Sciences; Merus; Abbvie; Amgen Other, Advisory role. Boehringer Ingelheim; Pfizer; Revolution Medicines; OSE Immunotherapeutics; Yuhan; GlaxoSmithKline; Natera; Johnson & Johnson/Janssen; Nuvalent; Systimmune; PharmaMar Other, Advisory role. Genentech/Roche; Merck; Alkermes; Merus; Elevation Oncology; Nuvalent; Gilead Sciences; Abbvie; Ellipses Pharma; Puma Biotechnology; OSE Immunotherapeutics; AstraZeneca; Cogent Biosciences ). Systimmune; Bristol-Myers Squibb Foundation; Duality Biologics; BioNTech; MediLink; Synthekine ).

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