Dr Gulley on the Investigation of PRGN-2009 Plus Bintrafusp Alfa in HPV-Associated Cancers

James L. Gulley, MD, PhD, senior investigator, Center for Immuno-Oncology, acting clinical director, Center for Cancer Research, National Cancer Institute, discusses a phase 1 trial of PRGN-2009 alone and in combination with bintrafusp alfa (M7824) in patients with recurrent and/or metastatic HPV-associated cancers.

At the 2023 ASCO Annual Meeting, investigators shared efficacy and safety findings for both PRGN-2009 alone and in combination with bintrafusp alfa, Gulley begins. Patients were assigned to arm 1A or arm 1B, where they were treated with PRGN-2009 monotherapy in dose escalation or PRGN-2009 administered at the recommended phase 2 dose in combination with 1200 mg of bintrafusp alfa once every 2 weeks, respectively. In the dose escalation arm, investigators determined that treatment of PRGN-2009 could be given safely at the recommended phase 2 dose.

In arm 1A, investigators noted stable disease as the best response, Gulley says. Results from arm 1B showed that PRGN-2009 was safe. Additionally, when evaluating responses in the combination arm, investigators noted that of 10 evaluable patients treated, 3 had objective response, 1 had a complete response (CR), and 2 had a partial response (PR), Gulley explains. Notably, one of the PRs was unconfirmed, Gulley adds. Moreover, the CR and confirmed PR were documented in patients with immune checkpoint blockade–resistant disease, Gulley concludes.