Coherus announces positive Phase II results for liver cancer treatment

Coherus BioSciences announced the final data from its Phase II clinical trial. The trial evaluated casdozokitug (casdozo), a selective Interleukin-27-targeting antibody. It was tested in combination with atezolizumab and bevacizumab for treating unresectable, locally advanced, or metastatic hepatocellular carcinoma (HCC). The results were presented at the 2025 ASCO Gastrointestinal Cancers Symposium held in San Francisco, California, from January 23-25, 2025.

The open-label Phase II trial included treatment-naïve patients and was designed to assess the combination therapy’s safety, efficacy, and response in HCC patients. Casdozo, a first-in-class antibody, targets IL-27, an immunoregulatory cytokine that plays a critical role in suppressing anti-tumour immune responses.

Key findings from the trial

The results revealed that the overall response rate (ORR) increased to 38 percent, a significant improvement compared to the previously announced 27 percent. Moreover, complete responses (CR), as per RECIST v1.1 criteria, rose to 17.2 percent from the initial 10.3 percent, showing not only an increase in response rates but also a deepening of those responses. These results were observed in both viral and non-viral etiologies of liver cancer, highlighting the versatility of casdozo in treating diverse causes of HCC. The toxicity profile remained consistent with what is known for atezolizumab and bevacizumab, with no new safety concerns identified during the trial.

Continued evaluation of Casdozokitug

The findings from this study have provided a strong rationale for continued evaluation of casdozokitug as a potential treatment for HCC, particularly in combination with VEGF and PD-(L)1 blockade. Casdozo is the only clinical-stage immunomodulatory cytokine antagonist targeting IL-27, an important immunotherapeutic target for solid tumours.

Dr Rosh Dias, Coherus’ Chief Medical Officer, commented on the data, saying, “The casdozo data in HCC demonstrate translation of the preclinical data in liver cancer to first-line HCC cancer patients with efficacy and a favourable safety profile. These data support the ongoing development of IL-27 as a promising novel target for advanced solid tumours.” He further highlighted the company’s continued efforts to advance casdozo’s development, mentioning, “We recently opened enrolment for our randomised, controlled, multinational Phase II trial of casdozo in combination with toripalimab, our anti-PD-1 antibody, plus bev. The combination of tori plus bev has demonstrated promising Phase III results in HCC, and we believe the addition of casdozo may further enhance anti-tumour effects and advance our next-generation immuno-oncology combinations focused on overcoming immune suppression in the tumour microenvironment.”

These results support the further development of IL-27-targeting therapies in liver cancer, which has seen increasing interest due to the potential of immune checkpoint inhibitors. Biomarker data from the study also confirmed that treatment with casdozo inhibited IL-27 signalling and activated immune responses in natural killer (NK) and T cells, reinforcing the mechanism of action that was demonstrated in preclinical trials.

Dr Daneng Li, Associate Professor at the City of Hope Comprehensive Cancer Center, emphasised the significance of these findings, stating, “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.” 

Building on these promising findings, Coherus BioSciences has opened enrollment for a new randomised Phase II trial evaluating casdozo in combination with bevacizumab and toripalimab (an anti-PD-1 monoclonal antibody) for patients with unresectable, locally advanced, or metastatic HCC. This study aims to assess the safety, efficacy, and dosing of the triplet combination and will enroll up to 72 patients.

The increasing focus on combination therapies in oncology, particularly for hard-to-treat cancers like HCC, has opened up exciting possibilities for more effective, tailored treatments. With casdozokitug showing promising results, it may play a key role in overcoming immune suppression in the tumour microenvironment and improving outcomes for advanced liver cancer patients.