Shots:
- The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026
- Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to support a potential accelerated approval, while OS data will support potential conversion to full approval
- Clearance was supported by the ongoing P-I/II study of CRB-701, where pts with 2L+ OPSCC treated at the 3.6mg/kg dose achieved a cORR of 42.9%, with an mDoR of 6.3 mos. & an mPFS of 5.6mos. (ongoing)
Ref: Corbus | Image: Corbus | Press Release
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