A recently published study centering on a chemotherapy-free targeted regimen for colorectal cancer published recently in the New England Journal of Medicine has been denounced as the “single worst reported randomized controlled trial” by Vinay Prasad, a practicing hematologist-oncologist and associate professor of medicine at Oregon Health and Science University in Portland Oregon.

Harsh Criticism

Professor Prasad was very harsh in his criticism of the BEACON trial on Twitter and in the podcast Plenary Session to offer basic information and for numerous redactions in the original published protocol as reported in the BMJ.

The Study

The study is a multi-center, randomized, open-label, 3-arm Phase III study to evaluate encorafenib plus cetuximab plus or minus binimetinib versus Investigator’s choice of either irinotecan/cetuximab or FOLFIRI/ cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability  of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase III portion of the study.

The Sponsor/Collaborators

The lead sponsor is Array BioPharma and collaborators include Merck KGaA (Damstadt, Germany), Pierre Fabre Medicament, and Ono Pharmaceutical Co. Ltd.

Investigator Prasad Comments on Twitter

Professor Prasad noted on Twitter “#BEACON trial is fascinating. The original protocol with redactions in inclusion criteria, endpoints, braf testing has been silently updated after my podcast But, they still have lots of info to report (thread) see e.g.s below ( HT @xrtGenomics)” 

Research Critic

Vinay Prasad, a practicing hematologist-oncologist and associate professor of medicine at Oregon Health and Science University in Portland Oregon

Call to Action: The study was originally scheduled to conclude September 20. Any TrialSite News viewer comments are appreciated.

Source: thebmj

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