Single-center phase 1-2 trial of novel combination immunotherapy for HPV-associated cancers

Patients who experience progression of advanced HPV-associated cancers after first-line systemic treatment have a poor prognosis and limited therapeutic options. A phase 1-2 trial at the National Cancer Institute (Bethesda, MD) evaluated the combination of HPV16 therapeutic vaccine PDS0101, the antibody-drug conjugate PDS01ADC), and the bifunctional anti-PD-L1/ TGFβ bintrafusp alfa in adult patients with advanced HPV-associated cancers. In this trial of 50 patients with previously treated advanced HPV-associated cancer, a response rate of 36.7% was achieved among immune checkpoint blockade-naïve patient, increasing to 62.5% among patients with HPV16-positive tumors. The median OS among these patients was not reached after median duration of follow-up of 37.7 months. The authors conclude that this trial idenfied a population of patients with HPV-associated cancer with promising antitumor responses and improved survival with PDS0101, PDS01ADC, and simultaneous PD-L1/TGFβ inhibition in patients with HPV16-positive tumors.