prismmarketview
Sep 29, 7:49 PM
$CRBP
First patient dosed in TEMPO-1, registrational trial of CRB-701 (Nectin-4-targeted ADC) in 2nd-line+ OPSCC (oropharyngeal squamous cell carcinoma). Randomized, ~250 patients, vs. investigator's choice of capecitabine/cetuximab/docetaxel.
Primary endpoint: ORR (targets accelerated approval); OS: secondary, targets full approval conversion. Prior Phase 1/2 (3.6mg/kg, ASCO 2026): 42.9% confirmed ORR, 6.3-mo median response duration, 5.6-mo median PFS (ongoing analysis), patient count in that cohort not disclosed. ~14,000 US patients/year eligible for 2nd-line OPSCC treatment (market size, not a sales forecast). FDA Fast Track in HNSCC + cervical cancer, no approval yet. No results timeline given, watch enrollment pace and randomized readout.
$CRBP #Biotech #Oncology
https://prismmarketview.com/corbus-pharmaceuticals-doses-first-patient-in-registrational-crb-701-throat-cancer-trial/
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