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Poster Discussion session - Immunotherapy of cancer 2

4471 - First in Human Study with GSK3359609 [GSK609], Inducible T cell Co-stimulator (ICOS) Receptor Agonist in Patients [Pts] with Advanced, Solid Tumors: Preliminary Results from INDUCE-1


22 Oct 2018


Poster Discussion session - Immunotherapy of cancer 2


Clinical Research;  Immunotherapy

Tumour Site


Aaron Hansen


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


A. Hansen1, T.M. Bauer2, V. Moreno3, M. Maio4, S. Groenland5, J. Martin-Liberal6, H. Gan7, D. Rischin8, M. Millward9, A.J. Olszanski10, D.C. Cho11, E. Paul12, M. Ballas13, C. Ellis13, H. Zhou14, S. Yadavilli13, J. Sadik Shaik15, E.V. Schmidt16, A. Hoos17, E. Angevin18

Author affiliations

  • 1 Division Of Medical Oncology And Hematology, Princess Margaret Hospital, M5G 2M9 - Toronto/CA
  • 2 Oncology, Sarah Cannon Research Institute, Tennessee Oncology, 37205 - Nashville/US
  • 3 Medical Oncology-start Madrid-fjd, University Hospital "Fundacion Jimenez Diaz", 28040 - Madrid/ES
  • 4 Division Of Medical Oncology And Immunotherapy, University Hospital of Siena, Istituto Toscano Tumori, 53100 - Siena/IT
  • 5 Medical Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek, 1066CX - Amsterdam/NL
  • 6 Oncology, Vall d`Hebron Institute of Oncology (VHIO)-Cellex Center, 08035 - Barcelona/ES
  • 7 Cancer Clinical Trial Centre, (Austin Health) Austin Hospital, 3084 - Melbourne/AU
  • 8 Department Of Medical Oncology, Peter MacCallum Cancer Centre, and the University of Melbourne, Melbourne/AU
  • 9 Linear Cancer Research, Sir Charles Gairdner Hospital, 6009 - Nedlands/AU
  • 10 Department Of Hematology/oncology, Fox Chase Cancer Center, 19111-2497 - Philadelphia/US
  • 11 Department Of Medicine, New York University Langone Medical Center, New York/US
  • 12 Oncology, R&d, GlaxoSmithKline, 27709 - Research Triangle Park/US
  • 13 Oncology, R&d, GlaxoSmithKline, 19426 - Collegeville/US
  • 14 Qsci, Clinical Statistics, GlaxoSmithKline, 19426 - Collegeville/US
  • 15 Clinical Pharmacology, GlaxoSmithKline, 19426 - Collegeville/US
  • 16 Early Oncology, Clinical Development, Merck & Co Inc, 19454 - North Wales/US
  • 17 Oncology, R&d, GlaxoSmithKline , 19426 - Collegeville/US
  • 18 Drug Development Department, Département D'innovation Thérapeutique Et Des Essais Précoces, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR

Abstract 4471


ICOS, a member of CD28/B7 superfamily, is expressed on T cells (TC) after TC receptor engagement with cognate antigen. ICOS provides a costimulatory signal augmenting TC expansion, function and survival. GSK609 is a humanized, IgG4 antibody engineered to reduce Fc-mediated depleting effects yet retain cross-linking for potent agonist activity against human ICOS. GSK609’s unique profile as a pure TC agonist void of TC depleting effects offers antitumor potential as monotherapy and in rational combinations with agents that modulate key immune pathways.


INDUCE-1 evaluates safety, PK, PD, and antitumor activity of GSK609 given as an intravenous (IV) infusion every 3 weeks (Q3W) alone (Part 1) and in combination with 200 mg pembrolizumab [P] Q3W (Part 2). Modified toxicity probability interval informed dose escalation [DE] decisions (≥ 3 pts/dose level [DL]). Eligible pts must have relapsed disease, adequate organ function, no active autoimmune disease requiring treatment; prior immunotherapy was allowed. Pts remained on treatment until progression or unacceptable toxicity. Blood was collected for safety, PK, PD; tumor biopsies collected for PD.


To date, 79 pts enrolled, Part 1: 22 in DE and 30 in PK/PD cohort; Part 2: 27 in DE. In Part 1, 45 pts (87%) had adverse events (AEs); most frequent (≥20%) regardless of cause were fatigue (29%) and pain (19%). Fatigue was the most frequent treatment-related (TR) event (15%); liver enzyme increases in 1 pt were the only TR AEs leading to discontinuation. In Part 2, 25 pts (93%) had AEs; most frequent were nausea (33%), fatigue (26%), arthralgia (22%), decreased appetite (22%) and vomiting (22%). Pyrexia was the most frequent TR AE (7%); no TR AE led to discontinuation. No DLTs were reported in DE with Part 2 ongoing at planned, top DL. In Part 1, GSK609 showed approximate dose proportional increases in systemic exposures over the 0.01 – 3 mg/kg DLs. Clinical activity was seen in Part 1 and Part 2.


GSK609 +/- P was well tolerated; MTD was not reached. AEs were manageable and most were unrelated to study treatment. Complete safety, PD and clinical activity data from DE and PK/PD will be presented.

Clinical trial identification

NCT02723955, first posted date: March 31, 2016.

Legal entity responsible for the study




Editorial Acknowledgement


A. Hansen: Research support: Genentech/Roche, Merck, GlaxoSmithKline, Bristol Myers Squibb, Novartis, Boston Biomedical, Boehringer-Ingelheim. T.M. Bauer: Consulting/advisory: Ignyta, Guardant Health, Loxo, Pfizer, Moderna Therapeutics; Research funding: Daiichi Sankyo, Medpacto, Inc, Incyte, Mirati Therapeutics, Medimmune, Abbvie, AstraZeneca, Leap Therapeutics, MabVax, Stemline Therapeutics, Merck, Lilly, GlaxoSmithKline, Novartis, Pfizer, Principa Biopharma, Genentech/Roche, Deciphera, Merrimack, Immunogen, Millennium, Ignyta, Calithera Biosciences, Kolltan Pharmaceuticals, Peleton, Immunocore, Roche, Aileron Therapeutics, Amgen, Moderna Therapeutics, Sanofi, Boehringer Ingelheim, Astellas Pharma, Five Prime Therapeutics, Jacobio. M. Maio: Patient’s fee for subjects enrolled in clinical trials: BMS, GSK, AZ, Roche, MSD, Incyte, Novartis; Advisor/Board member: BMS, GSK, AZ, Roche, MSD, Incyte; Honorarium, compensation for Advisory Boards: BMS, GSK, AZ, Roche, MSD, Incyte; Travel expenses related to participation to Ad Boards/Scientific meetings: BMS, GSK, AZ, Roche, MSD, Incyte. H. Gan: Consulting/advisory: Abbvie, Merck Serono; Speakers’ bureau: Abbvie, Bristol Myers Squibb, Ignyta; Research funding: Abbvie; Travel/accommodation expenses: Abbvie, Ignyta, MSD. D. Rischin: Research funding: Genentech/Roche, Merck, Amgen, Regeneron, Bristol-Myers Squibb, GSK. M. Millward: Consulting/advisory: Bristol-Meyers Squibb, Roche, Merck, Sharp & Dohme, Novartis, AstraZeneca. A.J. Olszanski: Consulting/advisory: Array, Bristol-Meyers Squibb, Merck, Takeda; Research funding: Amgen, Bristol-Meyers Squibb, EMD Serono, Immunocore, Incyte, Kura, Kyowa Hakko Kirin, Lilly, Pfizer, GSK, Takeda, Checkmate, Boston Biomedical, Astellas, Targovax. D.C. Cho: Honoraria: Bristol-Myers Squibb, Exelixis, Genentech; Consulting/advisory: Pfizer, Prometheus E. Paul, S. Yadavilli, J. Sadik Shaik, C. Ellis, H. Zhou: Employee and shareholder: GSK. M. Ballas: Employee and shareholder: GSK; Stockholder: BMS. E.V. Schmidt: Employment and stock holder: Merck. A. Hoos: Employee and shareholder: GSK; Non-Executive Director and stockholder: Imugene. E. Angevin: Consulting/advisory: GSK, MSD; Research funding: Abbvie, Roche, Sanofi. All other authors have declared no conflicts of interest.

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