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Mini Oral session 1: Gynaecological cancers

LBA32 - Efficacy and safety of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab in HPV 16- and/or 18- positive advanced cervical cancer (phase II): Safe and effective in both PD-L1 positive and negative

Date

10 Sep 2022

Session

Mini Oral session 1: Gynaecological cancers

Topics

Tumour Site

Cervical Cancer

Presenters

Sungjong Lee

Citation

Annals of Oncology (2022) 33 (suppl_7): S808-S869. 10.1016/annonc/annonc1089

Authors

S. Lee1, M. Lim2, Y.M. Kim3, J.H. No4, B. Kim5, C.H. Cho6, S.H. kim7, D.H. Jeong8, J. lee9, J.S. Park10, Y. Choi10, K.O. Jeon10, J.W. Woo10, Y.C. Sung11, S. Hur1

Author affiliations

  • 1 Obstetrics And Gynecology, The Catholic University of Korea - College of Medicine, 06591 - Seoul/KR
  • 2 Center For Gynecologic Cancer, National Cancer Center, 10408 - Goyang-si, Gyeonggi-do/KR
  • 3 Gyn Department, Asan Medical Center, 138-931 - Seoul/KR
  • 4 Obstetrics & Gynecology, Seoul National University Bundang Hospital, 13620 - Seongnam/KR
  • 5 Obstetrics And Gynecology, Samsung Medical Center, 135-710 - Seoul/KR
  • 6 Obstetrics And Gynecology, Dongsan Medical Center, Daegu/KR
  • 7 Obstetrics And Gynecology, Severance Hospital - Yonsei University College of Medicine, 03722 - Seoul/KR
  • 8 Obstetrics And Gynecology, Inje University Busan Paik Hospital, 614-735 - Busan/KR
  • 9 Obstetrics And Gynecology, Korea University Guro Hospital, 152-703 - Seoul/KR
  • 10 Clinical Development Dept, Genexine, Inc., 07789 - Seoul/KR
  • 11 Scientific Advisory Board, Genexine, Inc., 07789 - Seoul/KR
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Resources

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Abstract LBA32

Background

GX-188E (tirvalimogene teraplasmid) is a therapeutic DNA vaccine that encodes HPV-16 and HPV-18 E6 and E7 and induces HPV-specific T-cell responses. Pembrolizumab was approved for the treatment of advanced cervical cancer, based on an objective response rate (ORR) of 14.3% in patients with PD-L1 positive (CPS≥1). However, patients who were PD-L1 negative (CPS<1) showed no response to treatment with pembrolizumab. We aimed to investigate whether a combination of GX-188E plus pembrolizumab showed antitumor activity against advanced cervical cancer regardless of PD-L1 expression.

Methods

In this open-label, single-arm, phase 2 trial, patients with HPV-16 or HPV-18 positive advanced cervical cancer, and who had progressed after standard-of-care therapy were recruited in South Korea. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, 19 and optional dose at week 46, and intravenous pembrolizumab 200 mg every 3 weeks for up to 2 years or until disease progression. The primary endpoint was ORR assessed by the blinded independent central reviewers (BICR) using RECIST v1.1.

Results

A total of 65 patients have been enrolled and 60 patients were analyzed as efficacy population based on having at least one post-baseline tumor assessment. Among 60 patients, 36 patients had PD-L1 positive tumors and 24 patients were PD-L1 negative. According to BICR evaluation, 19 of 60 patients (31.7%) achieved best overall response; 6 patients had a complete response and 13 patients had a partial response. Especially, in PD-L1 negative population with 24 patients, this combination treatment showed significant efficacy (25.0% ORR). Median DOR was 12.3 months and median OS was 17.2 months. 22 of 65 patients (33.8%) had treatment-related adverse events (TRAEs) of any grade with three patients (4.6%) presenting with grade 3 or 4 TRAEs.

Conclusions

GX-188E vaccine combined with pembrolizumab in advanced cervical cancer was safe and tolerable, and showed significant efficacy compared with pembrolizumab alone particularly in patients with PD-L1 negative. This combination therapy could represent a new potential treatment for this patient population.

Clinical trial identification

NCT03444376.

Editorial acknowledgement

Legal entity responsible for the study

Genexine, Inc.

Funding

Sponsor: Genexine, Inc. Government funding: National Cancer Center Onco-Innovation Unit. Supply of pembrolizumab: Merck Sharp & Dohme, a subsidiary of Merck & Co.

Disclosure

S. Lee: Financial Interests, Institutional, Other, Sub-investigator: Catholic University of Korea, Seoul St. Mary's Hospital. M. Lim: Financial Interests, Institutional, Principal Investigator: National Cancer Center. Y.M. Kim: Financial Interests, Institutional, Principal Investigator: Asan Medical Center. J.H. No: Financial Interests, Institutional, Principal Investigator: Seoul National University Bundang Hospital. B. Kim: Financial Interests, Institutional, Principal Investigator: Samsung Medical Center. C.H. Cho: Financial Interests, Institutional, Principal Investigator: Keimyung University Dongsan Medical Center. S.H. kim: Financial Interests, Institutional, Principal Investigator: Yonsei University College of Medicine. D.H. Jeong: Financial Interests, Institutional, Principal Investigator: Inje University Busan Paik Hospital. J. lee: Financial Interests, Institutional, Principal Investigator: Korea University Guro Hospital. J.S. Park: Non-Financial Interests, Institutional, Full or part-time Employment: Genexine, Inc.; Financial Interests, Institutional, Sponsor/Funding, Genexine, Inc.: Genexine, Inc.; Financial Interests, Institutional, Stocks/Shares: Genexine, Inc.. Y. Choi: Non-Financial Interests, Institutional, Full or part-time Employment: Genexine, Inc.; Financial Interests, Institutional, Project Lead: Genexine, Inc.; Financial Interests, Institutional, Sponsor/Funding: Genexine, Inc.. K.O. Jeon: Non-Financial Interests, Institutional, Full or part-time Employment: Genexine, Inc.; Financial Interests, Institutional, Sponsor/Funding: Genexine, Inc.. J.W. Woo: Non-Financial Interests, Institutional, Member of the Board of Directors: Genexine, Inc.; Financial Interests, Institutional, Stocks/Shares, Genexine, Inc.: Genexine, Inc.; Financial Interests, Institutional, Sponsor/Funding: Genexine, Inc.. Y.C. Sung: Non-Financial Interests, Institutional, Advisory Board: Genexine, Inc.; Financial Interests, Institutional, Stocks/Shares: Genexine, Inc.. S. Hur: Financial Interests, Institutional, Principal Investigator: Catholic University of Korea, Seoul St. Mary's Hospital.

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