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Found 1 Presentation For Request "1955p"
1955P - Survival benefits of larotrectinib in an integrated dataset of patients with TRK fusion cancer
- Raymond McDermott (Dublin, Ireland)
Abstract
Background
Larotrectinib is a first-in-class, CNS-active, EMA- and FDA-approved selective tropomyosin receptor kinase (TRK) inhibitor. TRK proteins are encoded by the
Methods
Data were pooled from three clinical trials of pts with non-primary CNS TRK fusion cancer treated with larotrectinib. Disease status was assessed by investigators using RECIST v1.1. Primary endpoint was ORR and secondary endpoints included PFS, OS, duration of response (DoR) and safety outcomes. Data cut-off: 15 July 2019.
Results
A total of 175 pts were included in the integrated dataset. The median age was 43 y (range 0.1–84.0). The ORR was 78% (95% CI 71–84): 19% complete response, 59% partial response, 13% stable disease and 7% progressive disease. Median DoR was not estimable (NE) at a median follow-up of 13.5 months, with a 12-month DoR rate of 81% (95% CI 73–89). At a median follow-up of 13.8 months, median PFS was 36.8 months (95% CI 25.7–NE), showing extended benefit compared to previous analysis. Although median OS had not been reached with a median follow-up of 15.3 months, the 12-month OS rate was 90% (95% CI 85–95). Larotrectinib-related adverse events (AEs) were mainly Grade 1/2 with no new safety signals identified; two pts discontinued due to larotrectinib-related AEs.
Conclusions
These data confirm that treatment with larotrectinib offers extended survival benefit in pts with TRK fusion cancer. Larotrectinib continued to demonstrate a favourable long-term safety profile. Screening pts for
Clinical trial identification
NCT02122913, first posted April 25, 2014; NCT02637687, first posted 22 December 2015; NCT02576431: first posted 15 October 2015.
Editorial acknowledgement
Editorial assistance was provided by Farzana Miah, MSc, and Annabel Ola, MSc (Scion, London, UK), funded by Bayer HealthCare Pharmaceuticals, Inc.
Legal entity responsible for the study
Bayer HealthCare Pharmaceuticals, Inc. and Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lily and Company.
Funding
Bayer HealthCare Pharmaceuticals, Inc. and Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lily and Company.
Disclosure
R. McDermott: Travel/Accommodation/Expenses: Janssen-Cilag; Travel/Accommodation/Expenses: Pfizer; Honoraria (self): Bayer; Honoraria (self): Sanofi; Honoraria (self): Janssen; Honoraria (self): Astellas; Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Clovis; Research grant/Funding (self): Sanofi; Research grant/Funding (self): Janssen; Research grant/Funding (self): Bayer; Research grant/Funding (self): Astellas. C.M. van Tilburg: Advisory/Consultancy: Bayer; Advisory/Consultancy: Novartis. A.F. Farago: Advisory/Consultancy, Research grant/Funding (self): Bayer; Research grant/Funding (self): Loxo Oncology; Advisory/Consultancy, Research grant/Funding (self): Genentech; Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (self): AbbVie; Research grant/Funding (self): PharmaMar; Advisory/Consultancy, Research grant/Funding (self): Merck; Research grant/Funding (self): Ignyta; Research grant/Funding (self): Amgen ; Research grant/Funding (self): Lilly; Advisory/Consultancy: Boehringer Ingelheim; Advisory/Consultancy: Pfizer; Advisory/Consultancy: H3 Biomedicine; Honoraria (self): Clinical Care Options; Honoraria (self): Medscape; Honoraria (self): Onclive; Honoraria (self): Research to Practice; Honoraria (self): PeerView. S. Kummar: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer. D.S.W. Tan: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy: Merck; Advisory/Consultancy: Loxo; Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self): BMS; Honoraria (self): Takeda; Research grant/Funding (self): GSK. J. Berlin: Advisory/Consultancy, Research grant/Funding (self): Bayer. U.N. Lassen: Advisory/Consultancy: Bayer. F. Doz: Advisory/Consultancy, Travel/Accommodation/Expenses, All honoraria contributed to a research account at Institut Curie, not to his personal funds: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses, All honoraria contributed to a research account at Institut Curie, not to his personal funds: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses, All honoraria contributed to a research account at Institut Curie, not to his personal funds: Roche; Advisory/Consultancy, All honoraria contributed to a research account at Institut Curie, not to his personal funds: Celgene; Advisory/Consultancy, All honoraria contributed to a research account at Institut Curie, not to his personal funds: Loxo Oncology; Advisory/Consultancy, All honoraria contributed to a research account at Institut Curie, not to his personal funds: Tesaro; Advisory/Consultancy, All honoraria contributed to a research account at Institut Curie, not to his personal funds: Servier. L. Mascarenhas: Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Advisory/Consultancy, Research grant/Funding (institution), All honoraria contributed to his research institution CHLA : Lilly; Advisory/Consultancy, Research grant/Funding (institution), All honoraria contributed to his research institution CHLA : Salarius; Research grant/Funding (institution), All honoraria contributed to his research institution CHLA: Pfizer; Research grant/Funding (institution), All honoraria contributed to his research institution CHLA: Loxo; Research grant/Funding (institution), All honoraria contributed to his research institution CHLA: AstraZeneca; Research grant/Funding (institution), All honoraria contributed to his research institution CHLA: Merck; Research grant/Funding (institution), All honoraria contributed to his research institution CHLA: Novartis; Research grant/Funding (institution), All honoraria contributed to his research institution CHLA: Amgen. N. Federman: Shareholder/Stockholder/Stock options, Stock held in for-profit healthcare companies: Genmab; Shareholder/Stockholder/Stock options, Stock held in for-profit healthcare companies: Reata pharmaceuticals; Shareholder/Stockholder/Stock options, Stock held in for-profit healthcare companies: BlueBird Bio; Advisory/Consultancy: Zelda Pharmaceuticals; Advisory/Consultancy: Loxo Oncology; Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Licensing/Royalties: NanoValent Ltd. J.A. Reeves: Full/Part-time employment: Bayer. L. Dima: Full/Part-time employment: Bayer. N. Brega: Full/Part-time employment: Bayer. E. De La Cuesta: Full/Part-time employment: Bayer. T.W. Laetsch: Advisory/Consultancy, Research grant/Funding (self): Novartis; Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy, Research grant/Funding (self): Loxo; Advisory/Consultancy, Research grant/Funding (self): Lilly; Advisory/Consultancy: Cellectis; Research grant/Funding (self): Pfizer; Research grant/Funding (self): Abbvie; Research grant/Funding (self): Amgen; Research grant/Funding (self): Atara; Research grant/Funding (self): Biotherapeutics; Research grant/Funding (self): BMS; Research grant/Funding (self): Epizyme; Research grant/Funding (self): GSK; Research grant/Funding (self): Janssen; Research grant/Funding (self): Jubilant Pharmaceuticals; Research grant/Funding (self): Novella Clinical; Research grant/Funding (self): Servier. D.S. Hong: Research grant/Funding (self): AbbVie, Amgen, AstraZeneca, BMS, Daiichi-Sankyo, Eisai, Fate Therapeutics, Ignyta, Infinity, Kite, Kyowa, Lilly, Merck, MedImmune, Mirati, Molecular Templates, Mologen, NCI-CTEP, Novartis; Advisory/Consultancy, Research grant/Funding (self): Adaptimmune; Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy, Research grant/Funding (self): Genentech; Advisory/Consultancy, Research grant/Funding (self): Pfizer; Advisory/Consultancy, Research grant/Funding (self): Seattle Genetics; Advisory/Consultancy, Research grant/Funding (self): Takeda; Research grant/Funding (self), Travel/Accommodation/Expenses: Loxo Oncology; Research grant/Funding (self), Travel/Accommodation/Expenses: MiRNA; Research grant/Funding (self), Travel/Accommodation/Expenses: Genmab; Travel/Accommodation/Expenses: ASCO, AACR, SITC; Advisory/Consultancy: Alpha Insights; Advisory/Consultancy: Axiom; Advisory/Consultancy: Baxter; Advisory/Consultancy: GLG; Advisory/Consultancy: Group H; Advisory/Consultancy: Guidepoint Global; Advisory/Consultancy: Infinity; Advisory/Consultancy: Janssen; Advisory/Consultancy: Merrimack; Advisory/Consultancy: Medscape; Advisory/Consultancy: Numab; Advisory/Consultancy: Trieza Therapeutics; Shareholder/Stockholder/Stock options, ownership interests in Molecular Match (advisor), OncoResponse (founder), and Presagia Inc (advisor): Molecular Match; Shareholder/Stockholder/Stock options, ownership interests in Molecular Match (advisor), OncoResponse (founder), and Presagia Inc (advisor): OncoResponse ; Shareholder/Stockholder/Stock options, ownership interests in Molecular Match (advisor), OncoResponse (founder), and Presagia Inc (advisor): Presagia Inc. A. Drilon: Honoraria (self), Advisory/Consultancy: Verastem; Honoraria (self), Advisory/Consultancy: Tyra Biosciences; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Exelixis; Honoraria (self), Advisory/Consultancy: Hengrui Therapeutics; Honoraria (self), Advisory/Consultancy: BergenBio; Honoraria (self), Advisory/Consultancy: Beigene; Honoraria (self), Advisory/Consultancy: Helsinn; Honoraria (self), Advisory/Consultancy: Blueprint Medicines; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Pfizer; Honoraria (self), Advisory/Consultancy: TP Therapeutics; Honoraria (self), Advisory/Consultancy: Loxo Oncology, Bayer, Lilly, Takeda, Ariad, Millenium; Honoraria (self), Advisory/Consultancy: Ignyta/Genentech/Roche; Honoraria (self), Advisory/Consultancy: MORE Health; Research grant/Funding (institution): GlaxoSmithKline; Research grant/Funding (institution): Teva; Research grant/Funding (institution): Taiho; Research grant/Funding (institution): PharmaMar; Research grant/Funding (institution): Foundation Medicine; Licensing/Royalties: Wolters Kluwer; Travel/Accommodation/Expenses, food/beverages: Merck; Travel/Accommodation/Expenses, food/beverages: Puma Biotechnology; Honoraria (self), CME: Medscape; Honoraria (self), CME: OncLive; Honoraria (self), CME: PeerVoice; Honoraria (self), CME: Research to Practice; Honoraria (self), CME: Physicians Education Resources; Honoraria (self), CME: Targeted Oncology. All other authors have declared no conflicts of interest.