Coherus Oncology Pivots to Immuno-Oncology as Key Data Readouts Loom in 2026
Coherus Oncology (NASDAQ:CHRS) is approaching a defining stretch of clinical catalysts, with multiple data readouts expected across its immuno-oncology pipeline in the second half of 2026. The company also reported continued momentum for its only marketed oncology product, LOQTORZI, and a leaner cost structure after exiting the UDENYCA biosimilar business.
Chief Executive Officer Denny Lanfear framed the current period as one of initial data generation rather than definitive reporting, with the company's development strategy centered on overcoming immune resistance in cancer. He emphasized durability of clinical benefit and biomarker-driven patient selection as key priorities for the pipeline.
Chief Medical Officer Dr. Rosh Dias said three studies have completed enrollment: a first-line hepatocellular carcinoma study evaluating casdozokitug, plus tagmokitug cohorts in head and neck squamous cell carcinoma and colorectal cancer.
Tagmokitug, Coherus’ selective CCR8 cytolytic antibody designed to deplete regulatory T cells, is being tested in combination with toripalimab across several tumor types. In the 40-patient second-line head and neck squamous cell carcinoma study, the company is evaluating two dose levels of tagmokitug with toripalimab in patients with PD-1-resistant disease. Dias said the cohort is fully enrolled and the combination has shown an “acceptable and manageable” safety profile so far.
Early data from a subset of patients suggest activity in response rates and treatment duration. Preliminary tumor analysis also points to greater activity among HPV-positive patients and those with higher tumor immune regulatory index (TIRI) scores. Dias cautioned that the findings are based on small numbers and could change as the dataset matures.
The company expects all patients in the head and neck cohort to have sufficient follow-up and completed biomarker analyses to support a formal disclosure in October.
Chief Scientific and Development Officer Dr. Theresa LaVallee explained that the TIRI score is intended to identify an immune context where patients may benefit from tagmokitug. She acknowledged the initial analysis was retrospective and limited in size, but said the observed link between higher TIRI scores, HPV-positive tumors and clinical benefit is encouraging. “The question that we will explore is whether the same TIRI score will enrich for clinical benefit in other tumor types or in the first-line setting with and without chemotherapy,” LaVallee said.
Beyond head and neck cancer, Coherus is nearing completion of enrollment in a 40-patient second-line upper gastrointestinal adenocarcinoma cohort, including gastric, esophageal and gastroesophageal junction cancers. Data from that study are expected later this year. Enrollment continues in second-line and first-line esophageal squamous cell carcinoma cohorts, and the first 20-patient colorectal cancer cohort has completed enrollment, with initial colorectal data also anticipated in 2026.
A third tagmokitug protocol is set to begin in the fall, initially evaluating the drug in combination with Johnson & Johnson’s T-cell engager pasritamig in metastatic castration-resistant prostate cancer.
In the fully enrolled 72-patient first-line hepatocellular carcinoma study, Coherus is evaluating casdozokitug with toripalimab and bevacizumab. The trial is designed to assess the contribution of each component, as well as safety and efficacy, while supporting dose optimization under the FDA’s Project Optimus initiative. Dias noted that although enrollment was completed in March, only about half of participants have received three scans. Circulating tumor DNA and baseline IL-27 measurements are being collected and analyzed, and initial data are expected in the fourth quarter.
During the question-and-answer session, Dias said the company does not necessarily need to wait for a formal overall survival endpoint before deciding whether to move into a Phase III study. Future assessments will weigh response rate, clinical benefit rate, durability, safety, ctDNA and baseline IL-27 levels, he said.
On the commercial side, Chief Commercial Officer Sameer Goregaoker reported second-quarter LOQTORZI net sales of $13.6 million, up 15% from the prior quarter. Demand returned to a 10% to 15% quarterly growth range after a seasonal slowdown earlier in the year, and the company recorded its highest number of new patient starts since launch. Patient discontinuations returned to historical levels after a temporary uptick in the first quarter, while duration of therapy improved gradually. Coherus continues to target chemotherapy-only use in community settings, off-label immuno-oncology use, and appropriate treatment duration in nasopharyngeal carcinoma.
For full-year 2026, the company expects LOQTORZI revenue of $57 million to $62 million. Goregaoker reiterated prior expectations for a $15 million quarter in 2026, a $30 million quarter in 2027 and peak market share by 2028.
He also flagged potential dosing and treatment-duration education opportunities, noting that some physicians may be using a three-week schedule where a two-week schedule is indicated. The issue is primarily educational, he said, and the company is analyzing its scale.
Chief Financial Officer Bryan McMichael said second-quarter research and development expense from continuing operations fell to $21.4 million from $26.3 million a year earlier. Selling, general and administrative expense declined to $21.0 million from $26.0 million, marking the sixth consecutive quarter of lower SG&A expense from continuing operations. Coherus expects combined 2026 operating expenses of $170 million to $175 million.
McMichael attributed the reductions to lower headcount, reduced clinical and manufacturing expenses, and lower operating costs after the company exited its biosimilar business. Cash, cash equivalents and investments totaled $105.3 million at the end of the second quarter, down from $167 million at the end of the first quarter. About $39 million of the decrease was related to transition services agreement obligations, which are expected to be substantially diminished heading into 2027.
Coherus said it believes it has sufficient funding through key data readouts in 2026 and 2027. Legacy accrued rebates and reserves declined to $14.9 million from $28.8 million, while TSA payables and accrued liabilities decreased to $22.7 million from $61.6 million.
Founded in 2010 and headquartered in Redwood City, California, Coherus is a commercial-stage biopharmaceutical company focused on developing and commercializing biologic therapies for oncology support and immuno-oncology. The company originally built its franchise around biosimilars, including Udenyca and Fulphila, but has pivoted toward novel immunotherapy candidates as those assets wind down.
The upcoming data readouts, particularly the October tagmokitug disclosure in head and neck cancer and the fourth-quarter casdozokitug data in hepatocellular carcinoma, are widely viewed as key catalysts for the company. Analysts will be watching not only the clinical results but also whether the biomarker-driven approach can differentiate Coherus in a competitive immuno-oncology landscape.