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E-Poster Display

438P - Interim safety analysis of the phase IIb study of ramucirumab in combination with TAS102 vs. TAS102 monotherapy in metastatic colorectal cancer: The RAMTAS trial of the German AIO

Date

17 Sep 2020

Session

E-Poster Display

Topics

Immunotherapy

Tumour Site

Colon and Rectal Cancer

Presenters

Stefan Kasper

Citation

Annals of Oncology (2020) 31 (suppl_4): S409-S461. 10.1016/annonc/annonc270

Authors

S. Kasper1, R.D. Hofheinz2, S. Stintzing3, T.O. Götze4, M. Sinn5, T. Dechow6, T.J. Ettrich7, V. Keitel8, U. Graeven9, L. Fischer von Weikersthal10, A. Kolov11, T. Edelmann12, A. Stein13, T. Trarbach14, S. Junge15, C. Pauligk15, I. Virchow1, J. Siveke1, S. Al-Batran15, M. Schuler1

Author affiliations

  • 1 Westdeutsches Tumorzentrum, Universitätsklinikum Essen, 45147 - Essen/DE
  • 2 Tagestherapiezentrum Am Itm, University Medical Center Mannheim, 68167 - Mannheim/DE
  • 3 Department Of Hematology, Oncology, And Immunology (ccm), Charité Universitätsmedizin Berlin, 10117 - Berlin/DE
  • 4 Institute Of Clinical Cancer Research (ikf) At Krankenhaus Nordwest, UCT-University Cancer Center, 60488 - Frankfurt am Main/DE
  • 5 Ii. Medizinische Klinik, UKE Universitätsklinikum Hamburg-Eppendorf, 20246 - Hamburg/DE
  • 6 Studienzentrum Onkologie Ravensburg, Studienzentrum Onkologie Ravensburg, 88212 - Ravensburg/DE
  • 7 Klinik Für Innere Medizin I, Universitätsklinikum Ulm, 89081 - Ulm/DE
  • 8 Klinik Für Gastroenterologie, Hepatologie Und Infektiologie Gastroonkologisches Studienzentrum, Universitätsklinikum Düsseldorf, 40225 - Düsseldor/DE
  • 9 Kliniken Maria Hilf Gmbh, Krankenhaus St. Franziskus, 41063 - Mönchengladbach/DE
  • 10 Onkologie, MVZ Gesundheitszentrum St. Marien GmbH, 92224 - Amberg/DE
  • 11 Medizinische Klinik 2 Hämatologie, Onkologie, Immunologie, Palliativmedizin, VIDIA Christliche Kliniken Karlsruhe, 76137 - Karlsruhe/DE
  • 12 Medcenter Nordsachsen, Studien, 0443 - Schkeuditz/DE
  • 13 Facharztzentrum Eppendorf, Hämatologisch-Onkologische Praxis Eppendorf (HOPE), 20246 - Hamburg/DE
  • 14 /, Klinikum Wilhelmshaven, 26389 - Wilhelmshaven/DE
  • 15 Ikf, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, 60488 - Frankfurt am Main/DE

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Abstract 438P

Background

Patients (pts) with mCRC progressing under standard chemotherapy have limited therapeutic options. Trifluridin/Tipiracil (TAS102) significantly improved survival in patients with refractory mCRC. Ramucirumab (ram) is approved in combination with FOLFIRI for 2nd line treatment. There is a strong rationale to evaluate the efficacy and safety of ram in combination with TAS102 in pts with refractory mCRC.

Methods

This is a randomized, open label, multicenter, phase IIb study in pts with advanced mCRC. Eligible patients are randomized to receive either ram (8 mg/kg on d1+15, q4w) and TAS102 (35 mg/m2 on d1-5 and d8-12, q4w, arm A) or TAS102 alone (arm B). Primary endpoint is overall survival. A total of 144 patients will be enrolled in 30 sites. Main secondary endpoints include overall response rate, progression free survival and safety. As no toxicity data were available for the combination of TAS102 and ram, two interim safety analyses were planned. Here we present the data of the 2nd interim safety analysis after 40 patients were treated for at least two cycles in the ram/TAS102 combination arm.

Results

Patients (40 arm A, 40 arm B) had received a median of 2.5 treatment cycles in arm A and 2 cycles in arm B; 31 patients in treatment arm A and 32 patients in arm B discontinued participation prematurely, mainly due to progression. Most patients developed adverse events (AEs): grade 3 AEs were observed in 28 pts (70%) in arm A (24 treatment related) and 27 pts (67%) (17 treatment related) in arm B. More grade 4 AEs were seen in arm A 13 pts (32.5%) than in arm B 5 pts (12.5%). In total, 46 Serious AEs (SAEs) occurred, 27 in arm A (10 treatment related) and 19 in Arm B (2 treatment-related). 5 SAEs (3 in arm A, 2 in arm B) had a fatal outcome (one in arm A treatment-related). Within the analyzed population, no SUSAR occurred.

Conclusions

The safety data showed an increase in toxicity in the experimental arm, but no unexpected events. There was no excessive toxicity-rates or unacceptable risks. The risk-benefit-considerations and the conduct of the trial remain unchanged.

Clinical trial identification

NCT03520946; EudraCT 2017-004162-99.

Editorial acknowledgement

Legal entity responsible for the study

Institut für Klinische Krebsforschung IKF GmbH am Krankenhaus Nordwest.

Funding

Lilly Deutschland GmbH.

Disclosure

S. Kasper: Honoraria (self), Advisory/Consultancy, Other financial relationships: Amgen; Honoraria (self), Advisory/Consultancy, Other financial relationships: AstraZeneca; Advisory/Consultancy: Bayer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Other financial relationships: BMS; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Other financial relationships: Lilly; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Other financial relationships: Merck Serono; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Other financial relationships: Roche; Honoraria (self), Advisory/Consultancy, Other financial relationships: Sanofi Aventis; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Other financial relationships: Servier; Advisory/Consultancy: Janssen Pharmaceuticals; Research grant/Funding (self): Celgene. R.D. Hofheinz: Honoraria (self): Lilly; Honoraria (self): Servier. T.O. Götze: Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Bayer; Advisory/Consultancy: SERVIER; Advisory/Consultancy: Roche; Research grant/Funding (self): Deutsche Forschungsgemeinschaft; Research grant/Funding (self): Gemeinsamer Bundesausschuss. M. Sinn: Honoraria (self): Sanofi; Honoraria (self), Research grant/Funding (self): AstraZeneca; Honoraria (self): MCI; Honoraria (self), Research grant/Funding (self): Leo Pharma; Honoraria (self): Amgen; Research grant/Funding (self), Travel/Accommodation/Expenses: Servier; Research grant/Funding (self): MSD; Research grant/Funding (self): Incyte; Research grant/Funding (self): Boston medical. T.J. Ettrich: Advisory/Consultancy: Merck Serono; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Bayer; Advisory/Consultancy: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: Eisai; Advisory/Consultancy: Safoni/Aventis; Advisory/Consultancy: MSD; Travel/Accommodation/Expenses: Ipsen; Research grant/Funding (self): Baxalta/Shire. U. Graeven: Honoraria (self): Sirtex Medical; Honoraria (self): Daiichi Sankyo; Honoraria (self), Travel/Accommodation/Expenses: Boehringer Ingelheim; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen; Honoraria (self): Servier; Honoraria (self): AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck KGaA; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Hexal; Advisory/Consultancy: Celgene; Advisory/Consultancy: Johnson & Johnson; Advisory/Consultancy: MSD Oncology. S-E. Al-Batran: Advisory/Consultancy, Research grant/Funding (self): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Lilly; Advisory/Consultancy: Bristol-Myers Squipp; Advisory/Consultancy, Research grant/Funding (self): Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony: Nordic Bioscience; Advisory/Consultancy: Merck Sharp & Dohme; Speaker Bureau/Expert testimony: AIO gGmbH; Speaker Bureau/Expert testimony: Forum für Medizinische Fortbildung; Speaker Bureau/Expert testimony: MCI group; Shareholder/Stockholder/Stock options: Institut für Klinische Krebsforschung IKF GmbH; Research grant/Funding (self): Medac; Research grant/Funding (self): Hospira; Research grant/Funding (self): Sanofi; Research grant/Funding (self): German Cancer Aid; Research grant/Funding (self): German Research Foundation; Research grant/Funding (self): Federal Ministry of Education and Research; Research grant/Funding (self): Vifor Pharma. All other authors have declared no conflicts of interest.

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