BioAtla announces outcomes from Type B FDA meeting on ozuriftamab vedotin

BioAtla (BCAB) announced outcomes from its Type B meeting with the United States Food and Drug Administration. Ozuriftamab vedotin, CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2 which is expressed across many different solid tumors including head and neck cancer. Overexpression of ROR2 is driven by E6 / E7 oncoproteins associated with human papillomavirus infection and is associated with poor prognosis and resistance to chemo- and immunotherapies. OPSCC is recognized as a distinct anatomical entity within head and neck cancers with up to 80% of cases in the United States caused by HPV infection. As previously reported, Oz-V has demonstrated compelling clinical data in HPV+ OPSCC in a Phase 2 trial with an overall response rate of 45% and a median overall survival of 11.6 months, ongoing. Other studies using either cetuximab, docetaxel, or methotrexate monotherapy have reported an ORR of 0 – 3.4% and a median OS of 4.4 months in a similar patient population. OPSCC represents a sizable and rapidly growing patient population that is poorly served by EGFR inhibitors and other standard of care regimens. Key Outcomes from the FDA Type B Meeting: Pivotal Trial Design: For full approval, approximately 300 OPSCC patients prospectively randomized and stratified, one to one between two open label treatment arms. Oz-V Dose and Regimen: Patients randomized to the investigational arm will receive 1.8 mg/kg every other week. Investigator’s Choice control arm: Patients randomized to the control arm will receive either cetuximab, docetaxel, or methotrexate monotherapy. Accelerated Approval Endpoint: Based on interim analysis of enrolled patients, statistically significant improvement of confirmed ORR by Blinded Independent Central Review supported by an adequately characterized Duration of Response without detriment in OS. Full Approval Endpoint: Statistically significant improvement of OS.