Encorafenib and cetuximab in patients with metastatic, BRAF V600E-mutated, colorectal carcinoma: A multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria – BERING CRC

Background For the therapy of previously treated BRAF V600E-mutant metastatic colorectal cancer, the combination of encorafenib with cetuximab represents a new standard of care. The combination of encorafenib plus cetuximab was approved in the EU in June 2020. The approval was based on positive results from the BEACON CRC trial, which demonstrated a median overall survival (OS) of 8.4 mo (second data cut off 9.3 mo) and an objective response rate of 20% (both data cut offs). The observed tolerability profile was consistent with the known safety profile of each agent. Since data from controlled clinical trials are based on a selected patient population, the present non-interventional study (NIS) investigates the use of encorafenib + cetuximab under real-world conditions in a broader patient population. Trial design BERING CRC is an ongoing, multi-national, multi-centric, prospective, longitudinal NIS. It represents the first NIS to investigate the real-world use of the targeted therapy encorafenib + cetuximab in BRAF V600E-mutant metastatic colorectal cancer after prior systemic treatment in Germany and Austria. The project aims to enroll up to 500 patients from 90 German and Austrian sites with a total study duration of approx. 6 yrs. From Sep 2020 to Feb 2021, 16 patients have been included from 38 open sites. The study follows patients treated according to the SmPCs (Summary of Product Characteristics) and the primary objective is to assess the 1-year OS rate. Additional analyses include efficacy, quality of life, safety and tolerability of encorafenib + cetuximab treatment. The influence of prognostic factors on efficacy, safety and tolerability will also be analyzed. Clinical trial identification ClinicalTrials.gov Identifier: NCT04673955. Legal entity responsible for the study Pierre Fabre Pharma. Funding This study is funded by Pierre Fabre Pharma GmbH (Freiburg, Germany) and Pierre Fabre Pharma Austria (Wels, Austria). Disclosure S. Stintzing: Honoraria (self): AMGEN, Pierre-Fabre, Merck KgaA; Travel / Accommodation / Expenses: Amgen, Pierre-Fabre, Merck KgaA. F. Reichenbach: Full / Part-time employment: Pierre Fabre Pharma GmbH. D. Arnold: Honoraria (self): Merck, Shard and Dome, Terumo, Merck Serono, Boston Scientific, Bristol Myers Squibb, Pierre Fabre Pharma, Servier, Roche, GSK, Lilly, Sanofi (Genzyme); Honoraria (Institution): Merck, Sharp and Dome, Terumo, Merck Serono, Boston Scientific, Bristol Myers Squibb, Pierre Fabre Pharma, Servier; Advisory / Consultancy: Merck, Shard and Dome, Terumo, Merck Serono, Boston Scientific, Bristol Myers Squibb, Pierre Fabre Pharma, Servier, Roche; Research grant / Funding (self): Roche, Sanofi; Travel / Accommodation / Expenses: Terumo. A. Vogel: Honoraria (self): Daiichi Sankyo, AstraZeneca; Advisory / Consultancy: Daiichi Sankyo, AstraZeneca. TG. Prager: Advisory / Consultancy: Merck, Roche, Amgen, Sanofi, Lilly, Bayer, Servier, Taiho, CECOG, MSD, BMS, Pierre Fabre. All other authors have declared no conflicts of interest.