Colorectal Cancer: Update Bulletin #1
This edition presents the views and insights from three world leading key opinion leaders (KOLs) from North America and Europe on a variety of recent events in the colorectal cancer (CRC) market, including; Symphogen announcing detailed results from its randomised Phase II study with SYM004 compared to investigator-choice chemotherapy or best-supportive-care, in patients with advanced metastatic CRC and acquired resistance to anti-EGFR monoclonal antibodies (mAbs); Array BioPharma and Pierre Fabre announcing safety results and initial clinical activity data from the safety lead-in phase of the Phase III BEACON CRC study, which is assessing the safety and efficacy of binimetinib, encorafenib and cetuximab (BIN/ENC/CTX) in patients with BRAF-mutant CRC whose disease has progressed after one or two prior regimens in the metastatic setting; and The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion, recommending the granting of a marketing authorisation for Mvasi, a biosimilar version of Avastin (bevacizumab) from Amgen and Allergan, intended for the treatment of carcinoma of the colon or rectum and other indications.
Business Questions:
Business Questions:
- Are KOLs intrigued by SYM004’s mechanism of action?
- Were KOLs disappointed with the overall result from SYM004’s Phase II study, and did they think that the positive signal in certain patients warrants further investigation?
- Do KOLs believe that the design of the Phase II study for SYM004 contributed to its failure?
- What are the next steps for Symphogen and SYM004? Terminate development or confirm the positive efficacy signal seen in the Phase II study for SYM004 in a larger Phase III study?
- Where do KOLs believe that SYM004 will be used in the treatment of mCRC, and which products will it displace?
- Do KOLs believe that early data from the Phase III BEACON study, which is assessing the binimetinib/encorafenib/cetuximab (BIN/ENC/CTX) triplet combination, supports previously published data from the Southwest Oncology Group?
- What do KOLs think about the safety and early efficacy data for BIN/ENC/CTX; promising, or too early to tell?
- What will BIN/ENC/CTX need to show in order to compete with current treatment regimens: improvements in OS, ORR, and PFS, or all of the above?
- Are KOLs happy to have access to biosimilars, or will remaining concerns slow down uptake of bevacizumab biosimilars in the mCRC setting?
- What do KOLs think about the non-medical switching of patients from Avastin to bevacizumab biosimilars?
- Will the Centers for Medicare & Medicaid Services’ (CMS) announcement that all biosimilars will receive their own J code lead to greater biosimilar uptake?
