Corbus Pharmaceuticals (NASDAQ:CRBP) said updated clinical data for its experimental antibody-drug conjugate CRB-701 showed activity in oropharyngeal head and neck cancer and cervical cancer, while maintaining a safety profile the company characterized as consistent with prior results.
The company discussed the data during a conference call ahead of presentations at the 2026 American Society of Clinical Oncology annual meeting. Chief Executive Officer Dr. Yuval Cohen said the data reflect an April 1 cutoff and include an expanded safety database of 317 patients across doses and tumor types.
Safety Profile Remains Similar to Prior Update
Cohen said the safety database has “nearly doubled” since Corbus’ prior presentation at ESMO, but the overall safety picture remains similar. Across the 317-patient safety population, he said there were three grade 4 events and no grade 5 events.
The company highlighted several adverse-event categories:
- Peripheral neuropathy remained below 10%, with all cases grade 1 or 2 and none grade 3 or higher.
- Skin toxicity was mostly grade 1 or 2, with one grade 3 event and no grade 4 or higher events.
- Ocular toxicity continued to be observed, with most events grade 1 or 2, grade 3 events “just above 10%,” and one reversible grade 4 event.
- Discontinuations related specifically to ocular toxicity were below 2%, according to Cohen.
Dr. Glenn Hanna, director of the Center for Cancer Therapeutic Innovation at Dana-Farber Cancer Institute, said ocular toxicity has generally been manageable with monitoring, drug holds and eye drops. He emphasized that patients in this setting have incurable recurrent or metastatic disease and limited options after immunotherapy or chemoimmunotherapy.
Head and Neck Data Focus on Oropharyngeal Disease
Corbus presented updated results in head and neck cancer, with its ASCO data set including about 75 patients, up from roughly 60 at ESMO. Cohen said the company’s analysis showed a clear difference between oropharyngeal, generally HPV-associated disease, and non-oropharyngeal disease.
In the oropharyngeal group, Cohen said the higher 3.6 mg/kg dose given every three weeks produced a confirmed objective response rate of nearly 43%, with a disease control rate of nearly 86%. He said median duration of response was 6.3 months and progression-free survival was 5.6 months, with both measures ongoing. In non-oropharyngeal patients, responses were described as modest.
Hanna said oropharyngeal cancers include tumors in areas such as the tonsils, base of tongue and soft palate, where HPV-associated disease is common. He said about 85% of oropharyngeal cases in never-smokers in the United States are attributable to HPV, and he expects HPV-associated cases to continue rising through at least 2040 before plateauing later.
Hanna also said distinguishing oropharyngeal from non-oropharyngeal disease is generally straightforward for clinicians using exam findings, endoscopy and imaging. Cohen said Corbus prefers an anatomical definition of oropharyngeal cancer rather than requiring HPV testing or a companion diagnostic.
TEMPO-1 Trial Planned for This Summer
Corbus said it plans to launch TEMPO-1, a registrational study in oropharyngeal head and neck cancer, this summer. Cohen described the study as a controlled trial beginning with 250 patients, randomized between CRB-701 monotherapy and physician’s choice treatment.
The trial will include an adaptive feature. Cohen said the primary endpoint for accelerated approval is objective response rate, while full approval would be based on overall survival. He added that Corbus has alignment with the U.S. Food and Drug Administration on the plan, while noting that additional details will be provided at or after ASCO.
During the question-and-answer session, Hanna said response-rate benchmarks in the second- and third-line recurrent or metastatic head and neck cancer setting are generally around 20% to 25%. He said median overall survival in similar post-chemoimmunotherapy settings has often been around eight to 10 months, though oropharyngeal patients may do somewhat better than HPV-negative patients.
Cervical Cancer Results Also Updated
Corbus also discussed cervical cancer data scheduled for an oral presentation at ASCO. Cohen noted that cervical cancer is another HPV-driven tumor type and said CRB-701 showed a dose response in the indication.
At the top dose, Cohen said CRB-701 produced a confirmed objective response rate of 34% in cervical cancer, with duration of response reaching eight months and still ongoing. He compared that with Tivdak, an approved MMAE-armed antibody-drug conjugate targeting tissue factor, which he said has shown an objective response rate of about 17.8% and is associated with ocular toxicity, peripheral neuropathy, bleeding and skin toxicity.
Corbus is also testing CRB-701 with pembrolizumab in frontline head and neck cancer. Cohen said the company hopes to have those data at the beginning of next year, while emphasizing that the initial development focus is on the second-line or later setting, where the company and its clinical advisers see a significant unmet need.
About Corbus Pharmaceuticals (NASDAQ:CRBP)
Corbus Pharmaceuticals Holdings, Inc is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of therapeutic candidates for rare, life-threatening inflammatory and fibrotic diseases. The company’s lead investigational therapy, lenabasum, is a synthetic, oral cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation by harnessing the body’s innate resolution pathways. Corbus operates by advancing small-molecule compounds through preclinical and clinical studies to address unmet medical needs in autoimmune and inflammatory disorders.
Lenabasum is currently under evaluation in a Phase 3 clinical trial for diffuse cutaneous systemic sclerosis (dcSSc) and in a Phase 2 study for cystic fibrosis–related inflammation.
