Dr Ho on the Safety Profile of Ozuriftamab Vedotin in HPV-Associated OPSCC

“The every-other-week dosing was the safer, more tolerable version. [At that dose], only 15% of [patients experienced] grade 3 treatment-related adverse effects vs 30% at the other schedule. The other schedule also had a 10% grade 4 treatment-related adverse effect incidence.”

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

Ho began by explaining that, in a phase 2 trial (NCT05271604), investigators evaluated the agent at 2 dosing schedules via a 2-week-on, 1-week-off approach and an every-other-week approach. The every-other-week dosing schedule appeared to be the safer and more tolerable version of the agent, he continued. Patients treated via this approach (n = 20) experienced grade 3 treatment-related adverse effects (TRAEs) at a rate of 15% compared with 30% among patients treated with the other approach (n = 20), he added.

Investigators have been monitoring patients for fatigue, anemia, and cumulative peripheral neuropathy from the cytotoxic payload of ozuriftamab vedotin, Ho said. Overall, investigators are satisfied that the regimen appears to be tolerable, which is important in heavily pretreated patients with OPSCC who have received a lot of different therapies in the past, he concluded.

Additional safety data revealed that grade 4 and serious TRAEs did not occur in the every-other-week group. Grade 4 and serious TRAEs were reported at respective rates of 10% and 10% in the 2-week-on, 1-week-off group.

In July 2024, Oz-V received FDA fast track designation for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma who have experienced disease progression on or after platinum-based chemotherapy and a PD-(L)1 inhibitor.