AACR 2020 – DNA vaccine GX-188E synergises with pembrolizumab in HPV 16/18-positive cervical cancer


  • Elena Riboldi — Agenzia Zoe
  • Univadis
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Takeaway

  • 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).

Study design

  • 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.

Key results

  • 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.

Limitations

  • Single arm trial.

Since AACR 2020 is a virtual meeting, registered users can watch this session and all presentations online.