Corbus advances nectin-4 cancer asset toward registrational trials

Corbus Pharmaceuticals Holdings (NASDAQ:CRBP) released updated Phase 1/2 clinical data for its experimental antibody-drug conjugate, CRB-701, demonstrating therapeutic activity in patients with pretreated, human papillomavirus (HPV)-associated solid tumors that express high levels of the Nectin-4 protein.

The Norwood, Massachusetts-based biotechnology firm reported that at an optimal therapeutic dose of 3.6 mg/kg, the targeted treatment achieved a confirmed objective response rate (ORR) of 42.9% in patients with second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC), a prevalent subset of head and neck cancers.

Within the second-line cervical cancer cohort at the same dosage level, the confirmed objective response rate landed at 34.4%.

Durability metrics from the clinical dataset indicated a median duration of response (DOR) of 6.3 months for the oropharyngeal cancer arm and 8 months for the cervical cancer arm.

Progression-free survival (PFS)—measuring the duration patients lived without their disease worsening—was 5.6 months in the second-line OPSCC group and 4.3 months in the second-line cervical cancer group.

Safety profiles analyzed across a broader evaluable population of 317 patients across multiple tumor types showed an overall treatment discontinuation rate of 2.8% due to adverse events directly linked to CRB-701.

Ocular toxicities, a class-wide side effect frequently associated with therapies targeting Nectin-4, occurred in 66.2% of the safety cohort.

Severe ocular adverse events were less frequent, with Grade 3 instances reported in 12.6% of patients and a single recorded Grade 4 case. Discontinuations specifically attributed to these eye-related toxicities stood at 1.9%.

Backed by the clinical yields, Corbus secured regulatory alignment with the U.S. Food and Drug Administration regarding the randomized design parameters for upcoming registrational studies in both target indications.

The company remains on track to initiate TEMPO-1, its pivotal, registrational second-line OPSCC clinical trial, during the summer of 2026.