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Found 2 Presentations For Request "364O"
364O - Intracranial efficacy of entrectinib in patients with NTRK fusion-positive solid tumours and baseline CNS metastases
- Thomas John (Melbourne, Australia)
Abstract
Background
Methods
Pts with
Results
Full analysis set (FAS) comprised 16 pts with baseline CNS metastases per BICR (measurable or non-measurable), with 5 tumour types (8 NSCLC; 4 thyroid; 2 sarcoma; 1 salivary; 1 breast). Of these 16 pts, 8 had measurable CNS metastases (measurable set) and were evaluable for response. IC outcomes for FAS and measurable set are summarised (Table). IC ORRs were high in the FAS (50.0%) and measurable set (62.5%). IC efficacy was evident regardless of prior brain radiotherapy. In the safety population, neurotoxicity profile was similar in pts with (n=176) and without (n=328) baseline CNS metastases (per investigator), including cognitive disorders (6.3% and 6.4% respectively).
Conclusions
Entrectinib shows durable IC activity in pts with IC, intracranial; NE, not estimable.*As per RECIST v1.1 non-measurable CNS disease could only be categorised as CR, non-CR/non-PD, or PD.†IC PFS events occurred in 4 pts (2 PD, 2 deaths).‡IC PFS events occurred in 10 pts (3 PD, 7 deaths).
Intracranial outcomes Pts with Measurable set (n=8) Full analysis set* (n=16) IC ORR, n (%) 5 (62.5) 8 (50.0) CR 1 (12.5) 4 (25.0) PR 4 (50.0) 4 (25.0) SD, n (%) 1 (12.5) 1 (6.3) PD, n (%) 1 (12.5) 1 (6.3) Non-CR/non-PD, n (%) 0 5 (31.3) Missing/unevaluable, n (%) 1 (12.5) 1 (6.3) Median IC DoR in responders (95% CI) NE (5.0–NE) 8.0 (6.7–NE) Median IC PFS (95% CI) 10.1 (2.8–NE)† 8.9 (5.9–14.3)‡
Clinical trial identification
ALKA-372-001 (EudraCT 2012-000148-88); STARTRK-1 (NCT02097810); STARTRK-2 (NCT02568267).
Editorial acknowledgement
Third-party medical writing assistance, under the direction of the authors, was provided by Lewis Cawkwell, PhD, of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
T. John: Honoraria (self): AZ, Roche, Merck, MSD; Advisory/Consultancy: BMS, AstraZeneca, Boehringer Ingelheim, Takeda, Pfizer, Novartis, Merck, Ignyta, and Roche. C-H. Chiu: Honoraria (self): Pfizer, AstraZeneca/MedImmune, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, and Roche; Advisory/Consultancy: AstraZeneca/MedImmune, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, MSD, Novartis, Ono Pharmaceutical, and Roche. B.C. Cho: Advisory/Consultancy: Novartis, AstraZeneca, Boehringer Ingelheim, Roche, BMS, Ono, Yuhan, Pfizer, Eli Lilly, Janssen, Takeda, MSD, Janssen, Medpacto, Blueprint med-icines, Kanaph Therapeutic Inc; Research grant/Funding (institution): Novartis, Bayer, AstraZeneca, Mogam Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, AbbVie, Medpacto, GI-Innovation, Eli Lilly, Blueprint medicines; Shareholder/Stockholder/Stock options: TheraCanVac Inc, Gencurix Inc, Bridgebio Therapeutics, Kanaph Therapeutic Inc; Licensing/Royalties: Champions Oncology; Officer/Board of Directors: Daan biotherapeutics. M. Fakih: Honoraria (self): Amgen; Advisory/Consultancy: Array, Amgen, Pfizer, and Bayer Pharmaceuticals; Speaker Bureau/Expert testimony: Amgen, Guardant360; Research grant/Funding (institution): Amgen, AstraZeneca, Novartis. A.F. Farago: Honoraria (self): Dava Oncology, Clinical Care Options, Medical Learning Institute, Medscape, PeerView, Research to Practice; Advisory/Consultancy: Bayer, Loxo Oncology, Inc., Genentech, Roche, Bristol-Myers Squibb, AstraZeneca, AbbVie, PharmaMar, Boehringer Ingelheim, Merck, H3 Biomedicine, Pfizer, Syros; Research grant/Funding (self): Bayer, Loxo Oncology, Inc., Genentech, Roche, Bristol-Myers Squibb, AstraZeneca, AbbVie, PharmaMar, Merck, Ignyta, Amgen, Novartis. G.D. Demetri: Honoraria (self): M.J. Hennessey/OncLive, Medscape, AACR/ASCO; Advisory/Consultancy: Roche, Ignyta, Genentech, Bayer, EMD-Serono, Loxo Oncology, Daiichi Sankyo, WCG/Arsenal Capital, Blueprint Medicines, Merrimack Pharmaceuticals, PharmaMar, Pfizer, Novartis, Epizyme, AbbVie, GlaxoSmithKline, Janssen, Mirati, Sanofi, ICON PLC, Ziopharm, Research grant/Funding (institution): Roche, Ignyta, Bayer, Loxo Oncology, Daiichi Sankyo, Janssen, Pfizer, Novartis, Epizyme, AbbVie; Travel/Accommodation/Expenses: Epizyme, Roche; Shareholder/Stockholder/Stock options: Blueprint Medicines, G1 Therapeutics, Caris Life Sciences, Bessor Pharmaceuticals, Erasca Pharmaceuticals, Champions Oncology, Translate BIO, Relay Therapeutics, Caprion HistoGeneX; Licensing/Royalties: Novartis to Dana-Farber Cancer Institute; Officer/Board of Directors, Board of Directors Member: Blueprint Medicines, Translate BIO; Non-remunerated activity/ies: Alexandria Real Estate Equities; Advisory/Consultancy: Polaris Pharmaceuticals, Medscape, Relay Therapeutics, Caprion/HistoGeneX, McCann Health. K. Goto: Honoraria (self): Astellas Pharma Inc.; AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Chugai Pharma; Daiichi Sankyo Co., Ltd.; Guardant Health Inc.; IQVIA Services Japan K.K.;Janssen Pharmaceutical K.K.; Kyowa Hakko Kirin Co., Ltd; Life Technologies; Lilly; MSD; Advisory/Consultancy: Amgen Inc; Otsuka Pharma; Research grant/Funding (institution): Amgen Inc; Astellas Pharma; AstraZeneca; Boehringer Ingelheim; Bristol-Myers Squibb; Chugai Pharma; Daiichi Sankyo; Eisai; Ignyta; Janssen; Kyowa Hakko Kirin; Life Technologies; Lilly; Loxo; Medical & Biological Laboratories Co., Ltd; Merck Serono; MSD; Honoraria (self): Nippon Kayaku; Novartis; Ono Pharmaceutical; Otsuka Pharmaceutica; Pfizer; Taiho Pharmaceutical; Takeda; Research grant/Funding (institution): Novartis; Ono Pharmaceutical; Pfizer; Riken Genesis; Sumitomo Dainippon; Sysmex Corporation; Taiho Pharmaceutical; Takeda; Xcoo. R.C. Doebele: Advisory/Consultancy: Ignyta, Genentech/Roche, Loxo Oncology, Bayer, Eli Lilly, AstraZeneca, Pfizer, Blueprint Medicines, Anchiano, and Rain Therapeutics; Research grant/Funding (institution): Ignyta, Loxo, Mirati, Pfizer, Eli Lilly, and Strategia; Travel/Accommodation/Expenses: Ignyta, Genentech/Roche, Eli Lilly, Pfizer, Blueprint Medicines, and Rain Therapeutics; Shareholder/Stockholder/Stock options: Rain Therapeutics; Licensing/Royalties, Patent and biologic material licensing fees: Ignyta, Loxo, Abbott Molecular, Genentech/Roche, Chugai, Foundation Medicine, Black Diamond, and Rain Therapeutics, Voronoi, Pearl River, Ariad. S. Siena: Advisory/Consultancy: Amgen, Bayer, BMS, CheckMab, Celgene, Daiichi Sankyo, Incyte, Merck, Novartis, Roche, and Seattle Genetics. A. Drilon: Honoraria (institution): Ignyta/Roche/Genentech, Loxo, Bayer, lilly, TP Therapeutics, AstraZeneca, Pfizer, Blueprint, Takeda, Ariad, Millennium, Helsinn, BeiGene, BerGenBio, Hengrui, Exelixis, Tyra, Verastem, MORE Health, AbbVie, 14ner/Elevation Oncology, Axis, Peerview Institute,; Research grant/Funding (self): Foundation Medicine; Research grant/Funding (institution): Pfizer, Exelixis, Taiho, Teva, GlaxoSmithKline and PharmaMar; Licensing/Royalties: Wolters Kluwer; Honoraria (institution): OncLive, Paradigm Medical Communications, Remedica Ltd, ArcherDX, Foundation Medicine, PeerVoice, Research to Practice, Medscapem, WebMD. M.R. Patel: Advisory/Consultancy: Nektar Therapeutics; Research grant/Funding (self): Merck, Vyriad and Fate Therapeutics. S.V. Liu: Advisory/Consultancy: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Catalyst, Celgene, G1 Therapeutics, Genentech/Roche, Guardant Health, Inivata, Janssen, Lilly, Loxo, MSD, Pfizer, PharmaMar, Regeneron, Takeda; Research grant/Funding (institution): Alkermes, AstraZeneca, Bayer, Blueprint, Bristol-Myers Squibb, Corvus, Genentech, Lilly, Lycera, Merck, Merus, Molecular Partners, Pfizer, Rain, RAPT, Spectrum, Turning Point Therapeutics; Travel/Accommodation/Expenses: AstraZeneca, Genentech/Roche, MSD. M-J. Ahn: Honoraria (self): AstraZeneca, Lilly, Takeda, Roche, MSD; Advisory/Consultancy: AstraZeneca, Lilly, Takeda, Roche, MSD, Merck, Boehringer Ingelheim, Ono Pharmaceutical, Bristol-Myers Squibb, Alpha Pharmaceutical, and Progeneer. L. Bazhenova: Advisory/Consultancy: Genentech, BeyondSpring Pharma, AstraZeneca, BI, Takeda, Blueprint, Novartis; Research grant/Funding (self): BeyondSpring Pharma; Shareholder/Stockholder/Stock options: Epic Sciences. T.R. Overbeck: Advisory/Consultancy: AstraZeneca, BMS, Boehringer Ingelheim, Eli Lilly, Medac, MSD, Novartis, Roche/Genentech, Sanofi-Aventis, Tesaro/GSK; Travel/Accommodation/Expenses: AstraZeneca, Roche/Genentech. J. Nieva: Honoraria (self): AstraZeneca, Fujirebio, Western Oncolytics; Research grant/Funding (institution): Merck; Shareholder/Stockholder/Stock options: Epic Sciences, Cansera, Quantgene; Licensing/Royalties: Cansera. S-W. Kim: Advisory/Consultancy: AstraZeneca, Boering-Ingelheim, Lilly, Novartis; Speaker Bureau/Expert testimony: Boehringer Ingelheim; Research grant/Funding (self): AstraZeneca. L. Veronese: Full/Part-time employment: F. Hoffmann-La Roche Ltd. B-M. Day: Full/Part-time employment: Genentech. F. De Braud: Advisory/Consultancy: Bristol-Myers Squibb, Eli Lilly, Roche, Amgen, AstraZeneca, Istituto Gentili, Fondazione Internazionale Menarini, Octomet Oncology, Novartis, Merck Sharp & Dohme, Ignyta, Bayer, Noema, ACCMED, Dephaforum, Nadirex, Biotechspert, Pfizer, Speaker Bureau/Expert testimony: Bristol-Myers Squibb, Roche, Merck Sharp & Dohme, Ignyta,Dephaforum, prIME Oncology, Pfizer, Biotechespert; Research grant/Funding (institution): Roche, Novartis, Merck Sharp & Dohme, Bristol-Myers Squibb, Pfizer, Kymab, Celgene, Tesaro; Travel/Accommodation/Expenses: Bristol-Myers Squibb, Roche, Celgene, Amgen; Advisory/Consultancy: Tiziana Life Sciences, Pierre Fabre.
Invited Discussant 362O, 363O and 364O
- Emilie Le Rhun (Zurich, CEDEX, Switzerland)