- In advanced HPV 16- and/or 18-positive cervical cancer, the combination of the HPV DNA vaccine GX-188E with pembrolizumab markedly improved response rate.
- Combined therapy showed therapeutic effect in PD-L1-negative tumours.
- Combined therapy was safe and tolerable.
Why this matters
- HPV 16/18 account for 70% of cervical cancers.
- Objective response rate (ORR) of pembrolizumab, approved as second line therapy for PD-L1-positive advanced cervical cancer, is low (14.3%, KEYNOTE-158).
- The phase II study enrolled 36 patients with heavily pre-treated advanced/recurrent HPV 16 and/or 18-positive cervical cancer.
- Patients received GX-188E (2 mg, 6-7 doses) and pembrolizumab (200 mg, every 3 weeks for up to 2 years or until progression).
- In this interim analysis, safety and efficacy were evaluated in 28 and 26 patients, respectively.
- Funding: Genexine, National Onco Venture Korea.
- ORR was 42.3%, with 4 CRs (durable response) and 7 PRs.
- Response was higher in PD-L1-positive vs PD-L1-negative patients (50% vs 28.6%) and in HPV 16-positive vs HPV 18-positive patients (47.4% vs 28.6%).
- Anti-HPV blood T cell responses were observed in 78.3% of patients.
- Safety profile was similar to that of pembrolizumab monotherapy.
- Single arm trial.