Dr Ho on a Phase 3 Trial Evaluating Oz-V in Unresectable, Recurrent or Metastatic OSPCC

“We’re incredibly excited by the efficacy and safety profile of [Oz-V] in OPSCC. What we want to demonstrate is that Oz-V is superior to the SOC options for patients [with OPSCC] and to get this to be a therapeutic that is available for all our patients.”

Alan L. Ho, MD, PhD, chief of the Head and Neck Oncology Service and an attending physician at Memorial Sloan Kettering Cancer Center, discussed an upcoming phase 3 study evaluating the antibody-drug conjugate (ADC) ozuriftamab vedotin (CAB-ROR2-ADC; BA3021; Oz-V) in patients with treatment-refractory human papillomavirus (HPV)–associated oropharyngeal squamous cell carcinoma (OPSCC).

The study is building off positive results from a phase 2 trial (NCT05271604), which demonstrated an overall response rate (ORR) of 42% and a disease control rate of 92% for patients with p16-positive treatment-refractory HPV-associated OPSCC who received Oz-V (n = 12).

Ho began by emphasizing the excitement he and his colleagues have felt for Oz-V due to these promising data. He also pointed out that a main goal for the development of Oz-V is demonstrating superiority over current standard of care options for this population. In addition to demonstrating superiority over standard-of-care (SOC) options, Ho explained that making the ADC available to patients through an FDA approval is another goal for Oz-V development. Notably, Oz-V received a fast track designation from the FDA in July 2024 for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

Ho then highlighted key enrollment criteria for the phase 3 trial evaluating Oz-V, including patients with unresectable, recurrent or metastatic OPSCC. Moreover, Ho underscored the fact that all patients in the upcoming trial will have received a prior PD-1 inhibitor and platinum-based chemotherapy for recurrent or metastatic disease. Patients will be allowed to have received up to 3 prior lines of therapy and will be randomly assigned to receive Oz-V or SOC treatment. The trial will have primary end points of ORR and overall survival, Ho concluded.