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
CHS-114, toripalimab-tpzi, and casdozo. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- January 5, 2026
- Indication:
- In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Coherus Oncology, announced the publication of preclinical and clinical biomarker research in Molecular Cancer Therapeutics describing the high selectivity, picomolar binding affinity and significant effector mediated killing of CCR8+ cells of its investigational anti-CCR8 monoclonal antibody.
AI Summary
Coherus Oncology announced the publication of preclinical and clinical biomarker research showing its investigational anti-CCR8 monoclonal antibody, now named tagmokitug, has picomolar binding affinity and high selectivity for CCR8. The antibody showed no off-target binding and produced significant effector-mediated killing of CCR8+ cells, selectively eliminating CCR8+ regulatory T cells (Tregs) while sparing other T cells.
The study found CCR8 is highly abundant and densely expressed in many solid tumors. In mouse tumor models, anti-CCR8 treatment drove tumor regression and immune remodeling, with stronger activity when combined with anti-PD-1 therapy. These results support CCR8 as a promising target across multiple tumor types.
In a first-in-human study, translational data demonstrated proof of mechanism: dosing with tagmokitug led to selective reductions in CCR8+ Tregs in patients. Tagmokitug is being evaluated in Phase 1b/2a trials in combination with the PD-1 inhibitor toripalimab and chemotherapy.Read Announcement
- Drug:
- CHS-114
- Announced Date:
- November 7, 2025
- Indication:
- In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Coherus Oncology, announced new multiomic tumor and blood-based biomarker data from the dose expansion arm of its ongoing Phase 1b clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic HNSCC.
AI Summary
Coherus reported multiomic tumor and blood biomarker data from the dose expansion arm of its Phase 1b study of CHS-114, a selective cytolytic anti-CCR8 antibody, tested alone and with toripalimab in recurrent/metastatic head and neck cancer. In tumor biopsies, CHS-114 cut CCR8+ regulatory T cell (Treg) density by 74% and total FOXP3+ Tregs by 43% while sparing CCR8– Tregs. Intratumoral CD8+ T cells rose by about 73%, and the CD8+/CCR8+ Treg ratio increased roughly 12-fold, indicating tumor immune remodeling and proof of mechanism.
Blood tests showed strong depletion of CCR8+ Tregs with preserved CD4+ and CD8+ cells, plus higher CD8 cytotoxicity, activation, proliferation (Ki67), and inflammatory cytokines. Effects were greater and sustained when CHS-114 was given with toripalimab. The regimen had a manageable safety profile, showed early signs of antitumor activity, and two tested doses were pharmacologically active; dose optimization is ongoing.
Read Announcement- Drug:
- CHS-114
- Announced Date:
- October 3, 2025
- Indication:
- In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)
Announcement
Coherus Oncology announced an upcoming poster presentation at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) being held November 5-9, 2025, in National Harbor, Maryland.
AI Summary
Coherus Oncology will present a poster at the 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 5–9, 2025, in National Harbor, Maryland. Abstract #640 showcases CHS-114, an anti-CCR8 antibody that depletes tumor regulatory T cells and promotes immune remodeling in advanced solid tumors. The poster session is on November 8 at the Prince George ABC Exhibit Halls.
CHS-114 is also featured in SITC’s “Targets for Cancer IO” webinar series. Webinar 6 on October 22, 2025, from noon to 2 pm ET will explore CCR8’s role in immunosuppression and antibody development. Speakers include experts from Coherus Oncology and Vrije Universiteit Brussel.
Coherus is a commercial-stage oncology company with its PD-1 inhibitor LOQTORZI® on the market. Its immuno-oncology pipeline targets multiple solid tumors, aiming to boost patients’ antitumor responses and improve outcomes through novel antibody therapies.
Read Announcement- 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.
Read Announcement
Toripalimab-tpzi FDA Regulatory Events
Toripalimab-tpzi is a drug developed by Coherus Oncology for the following indication: in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
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:
- toripalimab-tpzi
- Announced Date:
- December 8, 2025
- Indication:
- in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC)
Announcement
Coherus Oncology, announced compelling six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI® (toripalimab-tpzi) plus chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (RM-NPC).
AI Summary
Coherus Oncology reported six‑year overall survival (OS) follow-up from the Phase 3 JUPITER-02 trial showing LOQTORZI (toripalimab‑tpzi) plus gemcitabine and cisplatin achieved a median OS of 64.8 months versus 33.7 months with chemotherapy alone — a 31‑month improvement. In this exploratory post‑hoc analysis there was a 38% reduction in the risk of death (HR 0.62; 95% CI, 0.45–0.85), indicating a large and durable survival advantage.
JUPITER-02 is a randomized, double‑blind, placebo‑controlled Phase 3 study in first‑line recurrent or metastatic nasopharyngeal carcinoma (RM‑NPC). The six‑year results, presented at ESMO Asia 2025, suggest LOQTORZI plus chemotherapy could meaningfully extend survival for patients with aggressive disease and support considering the combination as a first‑line option.
Investigators called the multi‑year improvement a meaningful shift, noting longer survival may translate to more time with family and life milestones. Coherus says these long‑term data reinforce LOQTORZI’s role in RM‑NPC care.
Read Announcement
Casdozo FDA Regulatory 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.
Read Announcement
