Colorectal Cancer [2016]: Bulletin #3
This edition presents key opinion leader (KOL) views on recent developments in the Colorectal Cancer (CRC) market. Topics covered include: Bristol-Myers Squibb (BMS) announcing interim data from the Phase II, CheckMate-142 trial evaluating Opdivo (nivolumab), alone and in combination with Yervoy (ipilimumab), for the treatment of patients with DNA mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC); Roche announcing data from two Phase I studies evaluating CEA-TCB (RG7802), alone and in combination with Tecentriq (atezolizumab), in patients with mCRC who have CEA-positive solid tumours; Incyte announcing the publication of Phase I/II data from the ongoing ECHO-204 trial evaluating the safety and efficacy of epacadostat (INCB024360) in combination with nivolumab for the treatment of CRC.
Business Questions
Business Questions
- How do KOLs view interim data from the CheckMate-142 trial and do they think they will be adequate for Opdivo and Opdivo/Yervoy to gain regulatory approval as a dMMR- or MSI-H-mCRC therapy?
- Given that only 5 percent of mCRC patients have dMMR or MSI-H biomarkers, is patient selection for Opdivo and Opdivo/Yervoy therapy likely to prove challenging?
- Where will Opdivo, with or without Yervoy, be positioned within the dMMR- or MSI-H-mCRC treatment paradigm and is it likely to encounter competition from similarly-indicated therapies?
- What do KOLs think of CEA-TCB’s mechanism of action and potential efficacy as a treatment for CEA-positive solid tumours in patients with mCRC?
- Do KOLs think the combination of CEA-TCB with atezolizumab will demonstrate superior efficacy over single-agent immunotherapy?
- If CEA-TCB/atezolizumab gains regulatory approval on the basis of later-stage data, what sort of indication do KOLs think the combination is likely to receive?
- How do KOLs view epacadostat as a potential treatment for CRC and are they concerned by the lack of activity that it shows in combination with nivolumab?
- Do KOLs think that the current Phase I data support the continued development of epacadostat/nivolumab as a therapy for mCRC and, if yes, where is the combination most likely to be used within the treatment paradigm if approved?