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Poster Discussion – Gastrointestinal tumours, non-colorectal

5184 - Perioperative FLOT + anti-PD-L1 avelumab (FLOT-A) chemo-immunotherapy in resectable oesophagogastric adenocarcinoma (OGA): safety and biomarker data from the ICONIC trial safety run-in


28 Sep 2019


Poster Discussion – Gastrointestinal tumours, non-colorectal


Michael Davidson


Annals of Oncology (2019) 30 (suppl_5): v253-v324. 10.1093/annonc/mdz247


M. Davidson1, S. Mansukhani1, N. Starling1, I. Chau1, D. Cunningham1, D. Watkins1, S. Rao1, R. Lazaro-Alcausi1, B. Griffiths2, L. Barber2, D. Morganstein1, M.D. Forster3, S. Davies4, R. Begum1, A. Gillbanks1, E. Kalaitzaki5, A. Wotherspoon1, K. Von Loga6, A. Chaudry1, M. Gerlinger2

Author affiliations

  • 1 Gastrointestinal Oncology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 2 Translational Oncogenomics, Institute of Cancer Research, SW36JB - London/GB
  • 3 Cancer Division, University College London Cancer Institute, WC1E6BT - London/GB
  • 4 Cardiology, Royal Brompton and Harefield NHS Foundation Trust, SW36NP - London/GB
  • 5 Royal Marsden Nhs Foundation Trust, Research data and Statistics Unit, SM2 5PT - Sutton/GB
  • 6 Molecular Pathology, Biomedical Research Centre, The Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB


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Abstract 5184


ICONIC is a single arm phase 2 trial investigating the safety and efficacy of 4 cycles pre-operative and 4 cycles post-operative FLOT-A in resectable OGA. We report results from the safety run-in phase and early translational biomarker data.


Eligible pts were enrolled into the 3 + 3 design dose finding stage. Standard dose FLOT was administered with 10mg/kg iv avelumab q2 weeks (dose level 0). Dose limiting toxicities (DLTs) were assessed for 28d. Biopsies were taken at baseline and post cycle 2.


At data cut-off (12/4/19) 6 pts were enrolled and completed pre-operative treatment. 1/6 pts experienced a DLT (chest pain during 5FU infusion), and dose level 0 was established as the safe dose for the efficacy stage of the trial. During pre-operative FLOT-A all pts experienced at least one grade 1-2 adverse event (AE), most commonly diarrhoea (5/6 pts), fatigue, nausea, peripheral neuropathy and hypokalaemia (all 4/6 pts); 3/6 pts experienced at least one grade 3-4 AE: neutropenia and elevated liver enzymes (1 pt), thrombotic event (1 pt) and cardiac chest pain (1 pt). 4/6 pts reported any grade chest pain and underwent cardiac work up: 1 episode was due to PE, 1 of likely GI origin and 2 cardiac in nature, which then recurred in one pt who was re-exposed to FLOT without avelumab. 3/6 pts completed 4 cycles pre-operative FLOT-A: 1 pt discontinued avelumab due to diarrhoea, 2 pts discontinued FLOT-A due to cardiac chest pain and switched to a regimen without 5FU. 5 pts have undergone surgery at data cut-off, without unexpected complications. Immunofluorescence shows changes of CD8-, memory- and regulatory T cell infiltrates between baseline and on-treatment biopsies, and detailed results will be presented.


This is the first data showing that FLOT can be combined with a PD-L1-inhibitor with FLOT-A having a manageable safety profile at dose level 0 (standard dose FLOT + 10mg/kg avelumab). As chest pain of variable aetiologies was observed in 4/6 patients this will be closely monitored and assessed during the efficacy phase. No unexpected complications have been observed during surgery following FLOT-A treatment.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Royal Marsden Hospitals NHS Foundation Trust.


Royal Marsden Hospital NHS Foundation Trust Institute of Cancer Research, Merck Pharmaceuticals.


M. Davidson: Travel / Accommodation / Expenses: Celgene. N. Starling: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Merck; Honoraria (institution): AstraZeneca. I. Chau: Advisory / Consultancy: Eli-Lilly; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Bayer; Advisory / Consultancy: Roche; Advisory / Consultancy: Merck-Serono; Advisory / Consultancy: Five Prime Therapeutics; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Oncologie International; Advisory / Consultancy: Pierre Fabre; Research grant / Funding (institution): Eli-Lilly; Research grant / Funding (institution): Janssen Cilag; Research grant / Funding (institution): Sanofi Oncology; Research grant / Funding (institution): Merck-Serono; Honoraria (institution): Eli-Lilly. D. Cunningham: Research grant / Funding (institution): Amgen; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): Merck-Serono; Research grant / Funding (institution): Medimmune; Research grant / Funding (institution): Merrimack; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Sanofi. D. Morganstein: Advisory / Consultancy: MSD; Advisory / Consultancy: BMS; Advisory / Consultancy: Roche. M.D. Forster: Research grant / Funding (institution): Merck; Honoraria (institution): Merck. M. Gerlinger: Research grant / Funding (institution): Merck; Research grant / Funding (institution): BMS. All other authors have declared no conflicts of interest.

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