Coherus Oncology Reports 89% Response Rate in Early ESCC Study

Key Points

• Early first-line ESCC data were promising: Tagmokitug combined with toripalimab and chemotherapy produced an 89% response rate in the expanded interim analysis, including a 100% response rate among PD-L1-positive evaluable patients. Coherus plans to expand the cohort to approximately 30–40 patients.
• Coherus is advancing the program toward regulatory discussions: The company plans to consult with the FDA in the first quarter of next year on the dose and potential expedited-development pathways, including accelerated approval strategies. It envisions randomized first- and second-line ESCC studies.
• Results varied across additional tumor types: Tagmokitug showed a 23.5% response rate in upper GI adenocarcinoma, 13% in previously treated HPV-positive head and neck cancer, and 6% in heavily pretreated colorectal cancer. No new safety signals were reported beyond known PD-1 inhibitor-related effects.

Coherus Oncology NASDAQ: CHRS presented interim clinical data for tagmokitug, an investigational therapy designed to target CCR8-positive regulatory T cells, in several solid-tumor settings. The company highlighted early activity in esophageal squamous cell carcinoma, or ESCC, and said it plans to expand cohorts and discuss potential regulatory paths with the U.S. Food and Drug Administration.

The ongoing TREGCHECK program is evaluating tagmokitug in combination with the PD-1 inhibitor toripalimab, with or without chemotherapy. Coherus said more than 120 patients have been treated across the program and reported no new safety signals beyond those associated with PD-1 inhibitors. The data remain interim, with enrollment and follow-up continuing in several cohorts.

First-Line ESCC Results

In first-line advanced or metastatic ESCC, Coherus is evaluating 700 mg of tagmokitug with toripalimab, 5-FU and cisplatin. At the October 14 data cutoff, 10 patients had been dosed and eight were evaluable.

Rosh Dias, Coherus’ chief medical officer, said all evaluable patients experienced tumor shrinkage. One patient had a confirmed complete response and five had confirmed partial responses, producing a confirmed objective response rate of 75%. The company said all PD-L1-positive evaluable patients responded, representing a 100% response rate in that subgroup.

After the cutoff, Coherus verified a partial response in a previously unconfirmed patient and identified another newly evaluable patient with a confirmed partial response. Including those scans, the company said the overall response rate would increase to 89%, while the PD-L1-positive response rate would remain at 100%.

The company also highlighted activity among patients with PD-L1-negative tumors, a population for which PD-1 treatment is not currently included in the U.S. label. Progression-free survival was not yet mature, although four of eight evaluable patients remained on therapy, according to Dias.

Coherus said it intends to expand the first-line cohort to roughly 30 to 40 patients. The company reported a clinical benefit rate of about 87% among evaluable patients, using a measure that includes complete responses, partial responses and stable disease lasting more than six months.

Second-Line ESCC and Development Plans

In second-line ESCC, Coherus is studying tagmokitug plus toripalimab without chemotherapy in patients previously treated with chemotherapy, with or without prior PD-1 or PD-L1 therapy. Seventeen of a planned 20 patients had been dosed at the time of the presentation.

Among eight evaluable patients, the 700 mg dose produced one confirmed partial response and one unconfirmed partial response. Coherus reported a 16.7% confirmed response rate and a 33.3% clinical benefit rate at the 700 mg dose. The company said the interim median progression-free survival was 5.5 months, though the dataset remains small and immature.

Dias said the results showed a dose-response relationship, with more durable activity at 700 mg than at 300 mg. Two patients at the higher dose remained on treatment for nearly eight months, including one with a PD-L1-negative tumor.

Theresa LaVallee, Coherus’ chief scientific and development officer, said the company plans to meet with the FDA in the first quarter of next year to align on the go-forward dose. She said the company expects to seek regulatory feedback after generating data in at least 30 patients and will evaluate expedited-development mechanisms, including potential accelerated approval strategies.

LaVallee said Coherus envisions randomized studies in first- and second-line ESCC that could assess objective response rate and duration of response as earlier endpoints while continuing to evaluate overall survival for potential full approval.

Additional Tumor Cohorts

Coherus also reported interim findings in head and neck cancer, upper gastrointestinal adenocarcinomas and colorectal cancer.

• Head and neck squamous cell carcinoma: In 23 evaluable HPV-positive patients previously treated with PD-1 or PD-L1 therapy, the company reported three confirmed partial responses and one unconfirmed partial response. The objective response rate was 13% and the clinical benefit rate was 26%. Coherus said a tumor-derived biomarker score, called TIRI, increased the clinical benefit rate to 45% in HPV-positive patients.
• Upper GI adenocarcinomas: At the 700 mg dose, Coherus reported four confirmed partial responses, an objective response rate of 23.5% and a clinical benefit rate just under 30%. Three of the four responding patients had previously received PD-1 therapy.
• Colorectal cancer: In a fourth-line-and-beyond cohort, the company reported one confirmed partial response, representing a 6% response rate, and a 12% clinical benefit rate. Coherus said the findings support evaluating the approach in earlier treatment lines.

Across the program, Coherus said the most common treatment-related adverse events included infusion-related reactions, fatigue, rash, diarrhea, pyrexia and lymphopenia, varying by cohort. The company reported no grade five tagmokitug-related adverse events. In the first-line ESCC combination with chemotherapy, some treatment discontinuations were attributed to renal toxicity and rash, according to Dias.

Chief Executive Officer Denny Lanfear said Coherus sees first- and second-line ESCC as a potentially integrated development opportunity, citing unmet need, activity across PD-L1 status and the possibility of global partnering. He added that the company expects to disclose data for its separate casdozokitug program in January 2027.

About Coherus Oncology (NASDAQ:CHRS)

Coherus Oncology, formerly known as Coherus BioSciences, is a commercial-stage biopharmaceutical company focused primarily on developing and commercializing medicines for cancer and other serious diseases. The company has built its business around biologic therapies, including biosimilars and innovative treatments intended to improve access to important medicines.

Its portfolio includes UDENYCA (pegfilgrastim-cbq), a long-acting treatment used to reduce the risk of infection associated with chemotherapy, and LOQTORZI (toripalimab-tpzi), an immuno-oncology therapy approved in the United States for certain patients with nasopharyngeal carcinoma.

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