BioAtla(US:BCAB) GlobeNewswire News Room·2025-06-02 12:00Core Insights - BioAtla, Inc. announced promising Phase 2 trial results for Ozuriftamab Vedotin (Oz-V) in HPV+ OPSCC patients, showing a 45% overall response rate (ORR) and a 100% disease control rate (DCR) [1][4] - The trial highlights a significant unmet need in the second-line and beyond HPV+ OPSCC patient population, where standard treatments have reported an ORR of only 3.4% [1][4] - The company plans to finalize the Phase 3 trial design for Oz-V with the FDA [1] Group 1: Clinical Trial Details - In the Phase 2 clinical trial, 40 heavily pretreated SCCHN patients received Oz-V at a dosage of 1.8 mg/kg, administered either every two weeks or on specific days of a 21-day cycle [2][7] - Tumor assessments were conducted via CT or MRI every 6 weeks for the first 12 weeks, then every 8 weeks up to one year [2] - Among the 40 patients, 22 had HPV+ OPSCC, with a median of 3 prior lines of therapy and a high failure rate of previous anti–PD-1 and platinum therapies [7] Group 2: Efficacy and Safety Data - In HPV+ OPSCC patients, Oz-V demonstrated an ORR of 45% (5 out of 11 patients) and a DCR of 100% (11 out of 11 patients) [7] - The median duration of response was 9.9 months, with median progression-free survival at 4.7 months and median overall survival at 11.6 months [7] - Most adverse events were low grade, with fatigue (57%) and anemia (32%) being the most common; only 15% experienced grade ≥3 adverse events [7] Group 3: Regulatory and Market Potential - The company believes there is potential for accelerated approval and full approval of Oz-V in the HPV+ OPSCC market [4] - Oz-V has received Fast Track Designation from the FDA to facilitate discussions regarding the proposed Phase 3 study [7][8] - The drug targets ROR2, a receptor associated with poor prognosis and resistance to therapies, indicating a strategic focus on addressing significant market needs in solid tumors [8]