Coherus BioSciences announced final results from its Phase 2 clinical trial of casdozokitug (casdozo) in combination with atezolizumab and bevacizumab for patients with unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC). The data, presented at the 2025 ASCO Gastrointestinal Cancers Symposium, demonstrated promising antitumor activity and an acceptable safety profile, supporting further investigation of casdozokitug in HCC.
The open-label Phase 2 trial included 30 treatment-naïve patients. Patients received casdozokitug 10 mg/kg IV every three weeks in combination with atezolizumab (1200 mg) and bevacizumab (15 mg/kg). The primary endpoint was safety and tolerability, while secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) per RECIST v1.1 and mRECIST criteria.
Improved Response Rates and Durability
The final data showed an overall response rate (ORR) of 38% (n=29), with 11 objective responses, including 5 complete responses and 6 confirmed partial responses. This represents an increase from the initially announced ORR of 27%. Complete response rates per RECIST v1.1 increased to 17.2% from the initial 10.3%, demonstrating a deepening of responses. The median progression-free survival (PFS) was 8.1 months, and the disease control rate (DCR) was 58.6%. According to mRECIST, the ORR was 43% (n=28) with a DCR of 60.7% and a median PFS of 8.4 months.
"The casdozo data in HCC demonstrate translation of the preclinical data in liver cancer to first-line HCC cancer patients with efficacy and a favorable safety profile," said Rosh Dias, M.D., Coherus’ Chief Medical Officer. "These data support the ongoing development of IL-27 as a promising novel target for advanced solid tumors."
Consistent Safety Profile
The triplet combination treatment was well-tolerated, with a side effect profile consistent with the known adverse event profiles of atezolizumab and bevacizumab. No new safety signals were identified.
New Phase 2 Trial with Toripalimab
Coherus has initiated a new randomized Phase 2 study (NCT06679985) evaluating casdozokitug in combination with bevacizumab and toripalimab, Coherus’ next-generation anti-PD-1 monoclonal antibody, in participants with unresectable locally advanced or metastatic HCC. The study is designed to enroll up to 72 patients, randomized to receive either a triple combination of casdozokitug, toripalimab, and bevacizumab, or a combination of toripalimab and bevacizumab without casdozokitug.
Addressing Unmet Needs in HCC
Hepatocellular carcinoma is a significant global health challenge, being the most common type of primary liver cancer in adults, accounting for approximately 90% of cases. According to the NCI Surveillance, Epidemiology and End Results Program (SEER), there will be an estimated 41,630 new cases and 29,840 deaths from liver and intrahepatic bile duct cancer in the US in 2024. The U.S. 5-year relative survival rate for liver and intrahepatic bile duct cancer is 21.7%.
"The treatment landscape for liver cancer, particularly for patients who are not eligible for surgery or who are metastatic, has improved in recent years thanks to immunotherapy combinations. However, there is still a clear unmet need for novel treatment options that can further improve survival without added toxicity," said Daneng Li, M.D., Associate Professor at the City of Hope Comprehensive Cancer Center. "These final casdozo data continue to be encouraging and compare very favorably in the current treatment landscape, and speak to the potential for its novel anti-IL-27 mechanism to address these substantial unmet needs."
