Replimune Group, Inc. announced that the Company has entered into a Master Clinical Trial Collaboration and Supply Agreement in relation to Replimune's RP2/3 program in colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Specifically, the companies will collaborate in third-line (3L) CRC and in first- and second-line (1L & 2L) HCC. Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab for 2L HCC and 3L CRC combined with RP3.

Roche will also supply atezolizumab and bevacizumab for 1L HCC combined with RP3, and for 3L CRC combined with RP2. Approximately 30 patients will be enrolled within each cohort. Replimune will have responsibility for operationalizing the clinical trial.

Atezolizumab in combination with bevacizumab is FDA approved and the current standard of care for the 1L treatment of unresectable HCC, with current treatment options for the treatment of 2L HCC being very limited. Combining RP3 with atezolizumab and bevacizumab has the potential to increase response rates and clinical benefit for patients with 1L disease, and to provide a much needed option for patients with 2L disease. While, bevacizumab is FDA approved to treat metastatic colorectal cancer, or mCRC, for first- or second-line treatment in combination with chemotherapy, late line CRC is a significant unmet need.

Replimune remains on track to initiate its Phase 2 development program with RP2/3 in the first half of 2023. As previously announced, this program is intended to include Phase 2 clinical trials in squamous cell carcinoma of the head and neck (SCCHN; locally advanced and recurrent/metastatic), hepatocellular carcinoma (HCC; first line and second line) and colorectal cancer (CRC; third line), combined with current standard of care where appropriate.