Coherus Presents Positive Phase 2 Clinical Data on Casdozokitug, a First-in-Class IL-27-Targeted Antibody, at the 2024 ASCO GI Cancers Symposium
– Data demonstrate early activity with casdozokitug/atezolizumab/bevacizumab; 38% objective response rate including three complete responses –
– Data support casdozo as a promising novel immuno-oncology agent with clinical activity in liver cancer that may be associated with IL-27 pathway biomarkers –
– Data support continued evaluation of casdozo with VEGF and PD-(L)1 blockade in HCC, including further clinical development to evaluate casdozokitug/toripalimab/bevacizumab –
“Doublet immunotherapy combinations for the treatment of liver cancer have improved outcomes for patients for whom surgery is not an option or whose cancer has spread. However, not all patients respond to current therapy and novel treatment options that can further improve survival without added toxicity are needed,” said
“These impressive early clinical and immune activation data for casdozo in HCC demonstrating an ORR of 38%, including 3 complete responses, and a favorable safety profile add to the growing body of data supporting IL-27 as a promising novel target in combination therapy for advanced solid tumors,” said
Lead-in portion of Phase 2 clinical trial design
The open-label lead-in portion of the Phase 2 clinical trial evaluated casdozo in combination with atezo and bev in 30 patients with treatment-naïve uHCC. Patients received casdozo 10 mg/kg IV q3w, in combination with atezo (1200 mg) and bev (15 mg/kg). The primary endpoint of the lead-in portion of the study was safety and tolerability. Key secondary endpoints included progression-free survival (PFS) and overall response rate (ORR) based on investigator review per RECIST v1.1 (primary) and mRECIST (secondary), as well as disease control rate (DCR). Further [Phase 2] clinical development of cazdozo in HCC is planned to evaluate casdozo/toripalimab (anti-PD-1 antibody)/bev.
Lead-in portion of Phase 2 clinical trial data
As of the data cutoff date (
Triplet blockade of the IL-27, PD-(L)1 and VEGF pathways with casdozo/atezo/bev has an acceptable safety profile to date with promising antitumor activity in IO naïve HCC.
- Triplet combination treatment was well tolerated with side effect profile consistent with known adverse event (AE) profiles of atezo/bev.
- Encouraging early activity with casdozo/atezo/bev:
- RECIST v1.1: ORR of 38% (n=29) with 11 durable objective responses including 3 complete responses and 8 partial responses (1 unconfirmed); median progression-free survival of 8.1 months and disease control rate of 58.6%.
- mRECIST: ORR of 43% (n=28) with 12 durable objective responses including 3 complete responses and 9 partial responses (1 unconfirmed); median progression-free survival not reached and disease control rate of 60.7%.
- Further analyses of samples from patients who responded to treatment (small n) indicate preliminary association between response and biomarkers of IL-27.
These results support continued evaluation of casdozo with VEGF and PD-(L)1 blockade in HCC. Coherus plans to evaluate the combination of casdozo/toripalimab-tpzi(Coherus’ anti-PD-1 antibody)/bev in future clinical trials.
Poster presentation details:
Title: Results from a phase 2 study of triplet blockade of the IL-27, PD-(L)1, and VegF pathways with casdozokitug (casdozo, CHS-388) in combination with atezolizumab (atezo) and bevacizumab (bev) in patients with unresectable, locally advanced or metastatic hepatocellular carcinoma (uHCC)
Poster Board number: B15
Abstract number: 470
Date and Time:
Location: Level 1, West Hall, Moscone West
Casdozokitug is a first-in-class human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Particular tumor types have been identified where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. Blocking IL-27 with casdozokitug in clinical trials has led to monotherapy tumor growth inhibition and partial responses in patients with non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC) (NCT04374877). An ongoing trial is studying combinations with PD-(L)1 pathway blockade in NSCLC and a planned clnical trial will study the triplet combination of IL-27, PD-(L)1 and VEGF pathway blockade in hepatocellular carcinoma (HCC). Casdozokitug has been granted Orphan Drug designation and Fast Track designation for the treatment of refractory hepatocellular carcinoma from the FDA. It is the first IL-27 antibody to enter the clinic.
About Coherus BioSciences
Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that will be synergistic with its proven commercial capabilities in oncology.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel anti-IL-27 antibody currently being evaluated in two on-going clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, ADCC-enhanced anti-CCR8 antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the novel pathway ILT4 with an IND filing planned in the first half of 2024.
Coherus markets LOQTORZI™ (toripalimab-tpzi), a novel next generation PD-1 inhibitor, UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, CIMERLI® (ranibizumab-eqrn), a biosimilar of Lucentis®, and YUSIMRY™ (adalimumab-aqvh), a biosimilar of Humira®.
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Coherus’ ability to find synergies between its I-O pipeline and its commercial operations; expectations for the timing of an IND filing for CHS-1000; statements that the Coherus immuno-oncology pipeline will extend survival and enhance outcomes for cancer patients.
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Source: Coherus BioSciences, Inc.