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Found 2 Presentations For Request "Abs: 540P"
540P - Entrectinib in patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) or NTRK fusion-positive solid tumours: Analysis of response by line of therapy
- Stephen V. Liu (Washington, United States of America)
Abstract
Background
Entrectinib is a potent, CNS-active ROS1/TRK/ALK inhibitor, which induces clinically meaningful responses in pts with
Methods
Patients with locally advanced/metastatic
Results
161 pts with
Conclusions
While pt numbers are relatively small, these data demonstrate similar responses to entrectinib in pts with *Pts may have received other therapies in the adjuvant or neoadjuvant setting that would not count as a line of therapy in this population. †Median duration of entrectinib exposure: 15.8 mos (IQR: 6.05–21.72). ‡Median duration of entrectinib exposure: 8.6 mos (IQR: 4.76–14.65).
Prior lines of systemic therapy in the metastatic setting* N ORR, % (n; 95% CI) N ORR, % (n; 95% CI) 31 83.9 (26; 66.3–94.6) 20 80.0 (16; 56.3–94.3) 38 63.2 (24; 46.0–78.2) 21 61.9 (13; 38.4–81.9) 13 69.2 (9; 38.6–90.9) 20 65.0 (13; 40.8–84.6) 12 83.3 (10; 51.6–97.9) 13 38.5 (5; 13.9–68.4)
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 Alix Biancardi, 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
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. 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. A. Drilon: Honoraria (institution): Ignyta/Roche/Genentech, Loxo/Bayer/Lily, 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, Medscape, WebMD. 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. M.R. Patel: Advisory/Consultancy: Nektar Therapeutics; Research grant/Funding (self): Merck, Vyriad and Fate Therapeutics. B.C. Cho: Advisory/Consultancy: Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, Ono, Yuhan, Pfizer, Eli Lilly, Janssen, Takeda, MSD, Janssen, Medpacto, Blueprint medicines, 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-J. Ahn: Honoraria (self): AstraZeneca, Lilly, Takeda, Roche, MSD; Advisory/Consultancy: AstraZeneca, Lilly, Takeda, Roche, MSD, Merck, Boehringer Ingelheim, Ono Pharmaceutical, Bristol-Myers Squibb, and Alpha Pharmaceutical, Progeneer. 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. 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. 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. J. Lee: Advisory/Consultancy: Oncologie, Seattle Genetics; Research grant/Funding (self): AstraZeneca, Eli Lilly & Company, Merck Sharp & Dohme. Y. Ohe: Honoraria (self): AstraZeneca, Chugai, Eli Lilly, ONO, BMS, Boehringer Ingelheim, Bayer, Pfizer, MSD, Taiho, Nippon Kayaku, Kyowa Hakko Kirin; Advisory/Consultancy: AstraZeneca, Chugai, ONO, BMS, Kyorin, Celltrion, Amgen, Nippon Kayaku; Research grant/Funding (institution): AstraZeneca, Chugai, Lilly, ONO, BMS, Kyorin, Dainippon-Sumitomo, Pfizer, Taiho, Novartis, Kissei, Ignyta, Takeda, Kissei, Daiichi-Sankyo, Janssen, LOXO; Officer/Board of Directors: JSMO, JLCS. S-H.I. Ou: Honoraria (self), Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer, Roche/Genentech, AstraZeneca, Takeda/ARIAD, Daiichi Sankyo; Research grant/Funding (institution): Pfizer, Roche/Genentech, AstraZeneca, Takeda/ARIAD, Daiichi Sankyo, Janssen, Mirati, Revolution Medicine, Lilly/LOXO Oncology, BluePrint Medicine; Shareholder/Stockholder/Stock options: Turning Point Therapeutics. P. Cassier: Honoraria (self): Novartis, Roche/Genentech, Blueprint Medicines, Amgen, AstraZeneca, Merck Serono; Honoraria (institution): Celgene, Plexxikon, AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Taiho Pharmaceutical, Toray Industries, Transgene, Loxo, GlaxoSmithKline, Innate Pharma, Janssen; Travel/Accommodation/Expenses: Roche, Amgen, Novartis, Bristol-Myers Squibb, Merck Sharp & Dohme, Netris Pharma. D.S.W. Tan: Honoraria (self): Novartis, Bayer, Boehringer Ingelheim, Celgene, AstraZeneca, Eli Lilly, and Loxo; Research grant/Funding (institution): Novartis, Bayer, AstraZeneca, Pfizer, and GlaxoSmithKline; Travel/Accommodation/Expenses: Novartis, Boehringer Ingelheim, Celgene, Merck, Pfizer, Roche, and Takeda. G.A. Otterson: Advisory/Consultancy: Pfizer, Genentech, AstraZeneca, Takeda, Guardant and Novocure; Speaker Bureau/Expert testimony: OncLive; Research grant/Funding (institution): AstraZeneca, Pfizer, Bristol-Myers Squibb, Genentech, Ignyta, and Merck. L. Veronese: Full/Part-time employment: F. Hoffmann-La Roche Ltd. S. Osborne: Full/Part-time employment: Roche. B. Simmons: Shareholder/Stockholder/Stock options: Roche/Genentech; Full/Part-time employment: Genentech/Roche. S. Siena: Advisory/Consultancy: Amgen, Bayer, BMS, CheckMab, Celgene, Daiichi Sankyo, Incyte, Merck, Novartis, Roche, and Seattle Genetics.
1165P - Subgroup analysis by Ki-67 and primary tumour origins of the randomized, placebo-controlled phase III study of surufatinib in advanced well-differentiated extrapancreatic neuroendocrine tumours (SANET-ep)
- Zhiwei Zhou (Guangzhou, China)
Abstract
Background
Surufatinib, a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptors (1,2,3), fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor, has demonstrated superior efficacy in extrapancreatic neuroendocrine tumors (NETs) in a phase III study (SANET-ep, ESMO 2019 Abs. LBA76). The proliferation marker Ki-67 and primary tumor origins are the major prognostic factors in NETs.
Methods
The post-hoc efficacy analysis of surufatinib versus placebo was conducted by Ki-67 subcategory (<3%, 3-10%, >10%) and primary tumor origins (foregut, midgut, hindgut, others or unknown) in patients (pts) with advanced well-differentiated (grade 1 or 2) extrapancreatic NETs. The primary endpoint (progression-free survival [PFS]) and secondary endpoint (objective response rate [ORR]) both by investigator assessment (RECIST1.1) were analyzed.
Results
Median PFS was significantly prolonged with surufatinib compared to placebo in subgroups of Ki-67 3-10% (7.6 vs 4.6 months [mo], hazard ratio [HR] 0.47,
Conclusions
Surufatinib demonstrated clinically significant benefits for pts with advanced well-differentiated extrapancreatic NETs compared to placebo. Results of this exploratory analysis were consistent with those reported for the SANET-ep primary analysis, and improved outcomes were observed across major subgroups.
Clinical trial identification
NCT02588170.
Legal entity responsible for the study
Hutchison MediPharma Limited.
Funding
Hutchison MediPharma Limited.
Disclosure
J. Li, J. He: Full/Part-time employment: Hutchison MediPharma Limited. W. Su: Shareholder/Stockholder/Stock options, Full/Part-time employment: Hutchison MediPharma Limited. All other authors have declared no conflicts of interest.