This section highlights FDA-related milestones and regulatory updates for drugs developed by Coherus Oncology (CHRS).
Over the past two years, Coherus Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
casdozo and CHS-114. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
casdozo - FDA Regulatory Timeline and Events
casdozo is a drug developed by Coherus Oncology for the following indication: Designed to inhibit the activity of this immunosuppressive cytokine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- casdozo
- Announced Date:
- January 22, 2025
- Indication:
- Designed to inhibit the activity of this immunosuppressive cytokine
Announcement
Coherus BioSciences announced final data from its Phase 2 open label clinical trial evaluating casdozokitug (casdozo), a selective and potent Interleukin (IL)-27-targeting antibody, in combination with atezolizumab (atezo) and bevacizumab (bev) in treatment naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC).
AI Summary
Coherus BioSciences announced final data from its Phase 2 open-label trial of casdozokitug (casdozo), a selective IL-27-targeting antibody, used alongside atezolizumab and bevacizumab. In treatment-naïve patients with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC), the combination achieved an overall response rate of 38% and a notable 17.2% complete response rate, indicating a deepening and durable response. The trial showed promising antitumor activity across both viral and non-viral etiologies of HCC while maintaining a safety profile consistent with the established profiles of atezolizumab and bevacizumab.
These results support further clinical evaluation of casdozokitug combined with VEGF and PD-(L)1 blockade. Encouraged by these findings, Coherus has initiated enrollment for a new randomized Phase 2 study testing casdozokitug in combination with bevacizumab and toripalimab, aiming to enhance anti-tumor effects in advanced HCC patients.
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CHS-114 - FDA Regulatory Timeline and Events
CHS-114 is a drug developed by Coherus Oncology for the following indication: In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CHS-114
- Announced Date:
- April 28, 2025
- Indication:
- In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Coherus BioSciences, Inc announced data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) evaluating two pharmacologically active doses of CHS-114 for dose optimization.
AI Summary
Coherus BioSciences announced promising early data from its ongoing Phase 1 trial investigating CHS-114, a selective, cytolytic anti-CCR8 antibody, as both a monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The study evaluated two pharmacologically active doses to optimize treatment. Notably, a heavily pretreated PD‑1 refractory patient showed a confirmed partial response, along with over 50% depletion of CCR8+ regulatory T cells and an increase in CD8+ T cells, indicating robust antitumor activity and proof of mechanism. These findings support the potential of CHS-114 to remodel the tumor microenvironment and enhance the immune response. A second-line dose optimization study in HNSCC and gastric cancer is ongoing, with anticipated results in the first half of 2026, paving the way for further development of this novel approach in oncology.
Read Announcement- Drug:
- CHS-114
- Announced Date:
- March 25, 2025
- Indication:
- In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Coherus BioSciences, Inc announced that an abstract highlighting interim data from its ongoing Phase 1 clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), has been selected for a poster presentation at the upcoming 2025 AACR Annual Meeting, being held April 25-30, 2025, at McCormick Place Convention Center in Chicago, Illinois.
AI Summary
Coherus BioSciences, Inc. announced that an abstract detailing interim data from its ongoing Phase 1 clinical trial on CHS-114 has been chosen for a poster presentation at the upcoming 2025 AACR Annual Meeting. The study is evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, both as a single agent and in combination with the anti-PD-1 antibody toripalimab in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The poster, titled “Phase 1 study of anti-CCR8 antibody CHS-114 with and without anti-PD-1 antibody toripalimab in patients with advanced solid tumors,” will be presented by lead author Dr. Francis Worden from the University of Michigan during a session for early-phase clinical trials. The findings could provide important insights into dosage optimization, safety, and the antitumor activity of CHS-114 treatment in patients with advanced cancers.
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