CSPC PHARMA (01093) has announced that its licensed candidate, CRB-701 (SYS 6002), developed by Corbus Pharmaceuticals, Inc., has received U.S. FDA approval to initiate a registration-directed clinical trial (trial code: TEMPO-1) for the second-line treatment of oropharyngeal squamous cell carcinoma (OPSCC).

This product is a next-generation antibody-drug conjugate (ADC) targeting Nectin-4, a clinically validated tumor-associated antigen that is clearly expressed in urothelial carcinoma and also highly expressed in various other cancers, including cervical cancer and head and neck squamous cell carcinoma (HNSCC).

Previously, the U.S. FDA granted two Fast Track designations for this product, covering its use in treating HNSCC and cervical cancer.

Where to begin

TEMPO-1 is a randomized controlled trial. It is designed to evaluate the efficacy and safety of CRB-701 compared to investigator-selected single-agent therapies (capecitabine, cetuximab, or docetaxel). The two primary endpoints are objective response rate (ORR), which could support potential accelerated approval, and overall survival (OS), which could support potential full approval.

Corbus expects to begin patient enrollment for TEMPO-1 in the third quarter of 2026.

Why just this FDA approval?

The FDA's approval to start this registration trial is supported by data from the ongoing Phase I/II clinical trial of this product, which was recently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Follow-up for this study is still ongoing.