Corbus Pharmaceuticals Presents CRB-701 Robust Clinical Responses in HNSCC and Cervical Cancers at ESMO25

Core Insights - Corbus Pharmaceuticals announced data from its Phase 1/2 clinical study of CRB-701, a next-generation antibody-drug conjugate targeting Nectin-4, to be presented at the ESMO25 Congress in Berlin [1][6][10] Study Overview - The multi-center Phase 1/2 study is being conducted in the U.S. and Europe, enrolling patients with various solid tumors, including head and neck squamous cell carcinoma (HNSCC), cervical cancer, and metastatic urothelial carcinoma (mUC) [2][9] - A total of 167 patients were enrolled, with 122 evaluable for efficacy, and a median of 3 prior lines of therapy [2][17] Efficacy Results - The objective response rates (ORR) for the 3.6 mg/kg dose were 47.6% in HNSCC, 37.5% in cervical cancer, and 55.6% in mUC [3][6] - Disease control rates (DCR) were reported as 61.9% for HNSCC, 68.8% for cervical cancer, and 88.9% for mUC [3][4] Safety Profile - No dose-limiting toxicities (DLTs) were observed during dose escalation, indicating a favorable safety profile [5][11] - The most common treatment-emergent adverse events (TEAEs) included dysgeusia (18.6%), anemia (21.0%), fatigue (21.6%), alopecia (24.0%), and keratitis (32.3%) [11] Biomarker Insights - Clinical responses were observed in patients with both high and low Nectin-4 expression, as well as in patients with varying HPV and PD(L)-1 statuses [7][8] Future Plans - The company plans to meet with the FDA to review the data and expects to initiate registrational studies by mid-2026 [9][12] - An HNSCC Key Opinion Leader (KOL) event will be held during ESMO25 to discuss the data further [10]