Abstract 1494P
Background
The DANTE study evaluates atezolizumab in the perioperative treatment of locally advanced, potentially resectable gastric or GEJ adenocarcinoma in combination with perioperative FLOT. Here, we report safety data from the beginning of the trial until Apr 2020.
Methods
DANTE is a multinational, prospective, multicenter, randomized, investigator-initiated, open label phase II trial. Patients (pts) with locally advanced, potentially resectable adenocarcinoma of the stomach and GEJ (≥cT2 and/or N-positive) without distant metastases are enrolled. Pts are randomized 1:1 to 4 pre-operative 2-week cycles of FLOT followed by surgery and 4 additional cycles of FLOT + atezolizumab at 840 mg every 2 weeks, followed by a total of 8 additional cycles of atezolizumab at 1200 mg every 3 weeks as monotherapy (arm A) or FLOT alone (arm B). Primary endpoint is time to disease progression or relapse after surgery (PFS/DFS).
Results
Recruitment started in Sep 2018; by May 2020, a total of 228 pts have been randomized. This analysis is based on safety data of 195 pts. 98 of the 195 pts were randomized into the experimental Arm A and 97 pts in Arm B. 142 of the pts were male and 53 female. The pts had a median age of 59 y in Arm A and 62 y in Arm B. 73.5% of pts in Arm A and 78.4% of pts in Arm B had an ECOG PS of 0. Tumor location and clinical stage was well balanced between the treatment arms. 7.7% of pts showed microsatellite instability. A total number of 193 serious adverse events (SAEs) were documented with 105 events in Arm A and 88 events in Arm B. 52 pts in each Arm developed at least one SAE. Of the 193 documented SAEs 49.5% in Arm A and 36.4% in Arm B were related to the study treatment. About 15% of pts in each arm had an SAE due to perioperative morbidity. 6 of the SAEs had a fatal outcome (2 in Arm A; 4 in Arm B) and one of these was related to study medication (Arm B).
Conclusions
No findings were recognized which require changes regarding the risk-benefit-considerations or conduct of the trial. Perioperative atezolizumab plus FLOT is feasible and safe; study continues recruitment.
Clinical trial identification
NCT03421288; EudraCT: 2017-001979-23.
Editorial acknowledgement
Legal entity responsible for the study
Institut für Klinische Krebforschung IKF GmbH am Krankenhaus Nordwest.
Funding
Roche.
Disclosure
S-E. Al-Batran: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Celgene; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Lilly; Advisory/Consultancy: BMS; Advisory/Consultancy, Research grant/Funding (self): Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony: Nordic Bioscience ; Advisory/Consultancy: Merck Sharp & Dohme ; Leadership role, Shareholder/Stockholder/Stock options: Institut für Klinische Krebsforschung IKF GmbH; Speaker Bureau/Expert testimony: AIO gGmbH; Speaker Bureau/Expert testimony: Forum für Medizinische Fortbildung ; Speaker Bureau/Expert testimony: MCI group; Speaker Bureau/Expert testimony: Nordic Bioscience; Speaker Bureau/Expert testimony: Promedicis; 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 of Germany ; Research grant/Funding (self): Vifor Pharma . S. Lorenzen: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Lilly; Advisory/Consultancy: Servier; Advisory/Consultancy: Sanofi/Aventis; Advisory/Consultancy: Celgene; Advisory/Consultancy: MSD Oncology. P.C. Thuss-Patience: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: MSD; Advisory/Consultancy: Nordic Bioscience; Advisory/Consultancy: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck; Research grant/Funding (institution): Novartis; Travel/Accommodation/Expenses: Teva; Travel/Accommodation/Expenses: Astellas Korea. E. Goekkurt: Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Roche; Advisory/Consultancy: Sanofi; Advisory/Consultancy: Pfizer; Advisory/Consultancy: BMS; Advisory/Consultancy: Merck Serono Serbia; Travel/Accommodation/Expenses: Servier. R.D. Hofheinz: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): Roche. A. Kretzschmar: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche. G.M. Haag: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy: EsoCap; Honoraria (self): Servier; Research grant/Funding (institution): Nordic Pharma ; Research grant/Funding (institution): Taiho Pharmaceutical ; Travel/Accommodation/Expenses: Lilly. A. Wicki: Research grant/Funding (self): Swiss Tumor Profiler Consortium; Travel/Accommodation/Expenses: BMS. N. Irahara: Full/Part-time employment: Roche. T.O. Götze: Advisory/Consultancy, Speaker Bureau/Expert testimony: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: Shire; Advisory/Consultancy: Bayer; Advisory/Consultancy: Celgene; Advisory/Consultancy: Servier; Speaker Bureau/Expert testimony: MCI Group; Research grant/Funding (self): German Research Foundation. N. Homann: Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Advisory/Consultancy: Lilly; Advisory/Consultancy, Speaker Bureau/Expert testimony: Servier; Advisory/Consultancy: BMS; Speaker Bureau/Expert testimony: Celgene; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: Merck. All other authors have declared no conflicts of interest.