Zhitong Finance App News, Shiyao Group (01093) announced that CRB-701 (SYS6002), which the group authorized to develop for CorbusPharmaceuticals, Inc. (Corbus), has been approved by the US Food and Drug Administration (FDA) to launch a registered clinical trial (trial code: TEMPO-1) for second-line (2L) treatment of oropharyngeal squamous cell carcinoma (OPSCC).
This product is a next-generation antibody-conjugated drug (ADC) targeting Nectin-4. Nectin-4 is a clinically proven tumor-related antigen that can be clearly expressed in urothelial carcinoma, and is also highly expressed in various tumors such as cervical cancer and head and neck squamous cell carcinoma (HNSCC). Previously, the US FDA had granted the drug two fast-track qualifications for the two indications of the product for treating HNSCC and cervical cancer.
TEMPO-1 is a randomized controlled trial. The study aimed to evaluate the efficacy and safety of this product compared to the researchers' choice of monotherapy (capecitabine, cetuximab, or docetaxel). The two main endpoints were objective response rate (ORR) (to support potentially accelerated approval) and overall survival (OS) (to support potential full approval). CORBUS is expected to launch TEMPO-1 patient enrollment in the third quarter of 2026.
The US FDA approved the launch of this registration trial based on data support from Corbus' ongoing phase I/II clinical trials of this product. These data were recently released at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. Currently, follow-up to this study is ongoing.