Corbus Pharmaceuticals Announces First Patient Dosed in TEMPO-1 Registrational Study of CRB-701 in Patients with 2L+ Oropharyngeal Cancer

What happened

Corbus Pharmaceuticals announced that the first patient has been dosed in TEMPO-1, its registrational trial of CRB-701 for patients with second-line and beyond (2L+) oropharyngeal squamous cell carcinoma (OPSCC). The company characterizes CRB-701 as a next-generation Nectin-4 targeted antibody drug conjugate (ADC) and framed TEMPO-1 as a study intended to generate evidence that could support regulatory submissions.

Sources: S1

Study design and endpoints

According to the release, TEMPO-1 is a randomized controlled study with a planned enrollment described as n=250. The study's primary endpoint is objective response rate (ORR), which the company states is intended to support a potential accelerated approval; overall survival (OS) is identified as intended to support potential conversion to full approval. The comparator is described as investigator’s choice of capecitabine, cetuximab or docetaxel.

Sources: S1

Prior clinical data cited by Corbus

Corbus references data from its ongoing Phase 1/2 study presented at ASCO 2026 to support the TEMPO-1 program. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, the company reports a confirmed ORR of 42.9%, a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing). The company also notes the FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.

Sources: S1

Context and potential relevance

The release frames an increasing incidence and prevalence of OPSCC in the U.S., driven by HPV infection, and states an annual estimated patient pool for 2L treatment and mortality figures. Corbus positions the TEMPO-1 study as a step toward evaluating CRB-701 as a potential targeted therapeutic option in an area the company describes as underserved.

Sources: S1

What remains uncertain

• All clinical efficacy and safety numbers cited are from the company's press release and prior company-presented Phase 1/2 data; these are sponsor-reported and not independently verified in this release.
• The TEMPO-1 study is described as intended to support regulatory submissions, but the press release expressly states there can be no assurance that TEMPO-1 will achieve its primary or secondary endpoints or that CRB-701 will receive accelerated or full approval.
• Reported Phase 1/2 results are from an ongoing study and include an ongoing median PFS; the release does not supply patient-level data, confidence intervals, or full safety dataset details in this announcement.