Dr Ho on the Efficacy of Oz-V in p16+ Oropharyngeal Squamous Cell Carcinoma

“This is promising activity in a cohort of patients [who] were heavily pretreated; [approximately] two-thirds of those patients had been previously treated with 3 or more lines of prior therapy. Based upon that activity, the plan now is to investigate Oz-V in a phase 3 randomized trial in patients with OPSCC.”

Alan L. Ho, MD, PhD, chief of the Head and Neck Oncology Service and an attending physician at Memorial Sloan Kettering Cancer Center, discussed efficacy findings from a phase 2 trial (NCT05271604) evaluating the antibody-drug conjugate ozuriftamab vedotin (CAB-ROR2-ADC; BA3021; Oz-V) in patients with treatment-refractory human papillomavirus–associated oropharyngeal squamous cell carcinoma (OPSCC).

The phase 2 trial enrolled 40 patients with head and neck cancer. Among 13 evaluable patients with p16-positive OPSCC who received Oz-V on an every-2-weeks dosing schedule, the overall response rate was 42%, and the median overall survival was 11.6 months (95% CI, 4.7-not evaluable). Furthermore, the disease control rate was 92%, and the median progression-free survival was 4.7 months (95% CI, 2.4-13.9).

Notably, patients in the full analysis set and across dose levels in the p16-positive OPSCC population had all received a median of 3 prior lines of therapy. Among those with p16-positive OPSCC who received Oz-V every 2 weeks, all had received prior PD-1 inhibition, 85% had received prior platinum-based chemotherapy, and 54% had received prior taxanes.

Ho emphasized that Oz-V has shown promising activity in these heavily pretreated patients. Going forward, the agent is planned to be investigated further in a phase 3 randomized trial in patients with OPSCC.

Disclosures: Ho reported receiving conference/travel support from BioAtla; receiving research support from Astellas, Daiichi Sankyo, Glaxo Smith Kline, Hookipa, Merck, TILT, and Verastem; receiving consulting fees from Cantor Fitzgerald and Inhibrx; participating in advisory boards with DayOne Bio and Glaxo Smith Kline Takeda; and performing speaking roles with Horizon CME, Miami Cancer Research Center, Mount Sinai, New York University, Northwell, Novartis, Physician Education Resource and Remix Therapeutics.