Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

E-Poster Display

820P - Phase II study of pamiparib in Chinese patients (pts) with advanced ovarian cancer (aOC)

Date

17 Sep 2020

Session

E-Poster Display

Presenters

Xiaohua Wu

Citation

Annals of Oncology (2020) 31 (suppl_4): S551-S589. 10.1016/annonc/annonc276

Authors

X. Wu1, J. Zhu2, J. Wang3, Z. Lin4, B. Kong5, R. Yin6, W. Sun7, Q. Zhou8, S. Zhang9, D. Wang10, H. Shi11, Y. Gao12, Y. Huang13, G. Li14, X. Wang15, Y. Cheng16, G. Lou17, L. Li18, X. Mu19, M. Li20

Author affiliations

  • 1 Department Of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN
  • 2 Department Of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou/CN
  • 3 Hunan Cancer Hospital/the Affiliated Cancer Hospital Of Xiangya School Of Medicine, Central South University, Changsha/CN
  • 4 Department Of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou/CN
  • 5 Department Of Obstetrics And Gynecology, Qilu Hospital of Shandong University, Ji'nan/CN
  • 6 Department Of Obstetrics And Gynecology, West China Second University Hospital, Sichuan University, Chengdu/CN
  • 7 Department Of Gynecologic Oncology, Anhui Provincial Cancer Hospital, The First Affiliated Hospital of USTC, Hefei/CN
  • 8 Department Of Gynecologic Oncology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing/CN
  • 9 Department Of Obstetrics And Gynecology, The First Hospital of Jilin University, Changchun/CN
  • 10 Department Of Gynecology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang/CN
  • 11 Department Of Obstetrics And Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian/CN
  • 12 Department Of Gynecological Oncology, Peking University School of Oncology, Beijing Cancer Hospital, Beijing Institute for Cancer Research, Beijing/CN
  • 13 Department Of Gynecological Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan/CN
  • 14 Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan/CN
  • 15 Department Of Oncology And Hematology, The Second Hospital of Jilin University, Changchun/CN
  • 16 Department Of Oncology, Jilin Cancer Hospital, 130012 - Changchun/CN
  • 17 Department Of Gynecology, Harbin Medical University Cancer Hospital, Harbin/CN
  • 18 Biostatistics, BeiGene (Beijing) Co., Ltd., Beijing/CN
  • 19 Clinical Development, BeiGene (Shanghai) Co., Ltd., Shanghai/CN
  • 20 Clinical Development, BeiGene (Beijing) Co., Ltd., Beijing/CN
More

Resources

Abstract 820P

Background

Pamiparib, an investigational, selective inhibitor of PARP1/2, has PARP-DNA complex trapping capabilities. The first-in-human study (NCT02361723) established the pamiparib phase II dose as 60 mg po BID. Responses were reported in BRCA mutated or wild-type and platinum-sensitive/resistant aOC. Here we present phase II results from an ongoing phase I/II study in Chinese pts with advanced solid tumors (NCT03333915).

Methods

Patients with platinum-sensitive (cohort 1) and platinum-resistant (cohort 2) aOC were enrolled. Patients with known/suspected deleterious germline BRCA1/2 mutation and ≥2 prior lines of chemotherapy were eligible. The primary endpoint was objective response rate (ORR) assessed by an independent review committee (ORRIRC) per RECIST v1.1.

Results

As of 2 Feb 2020, 113 pts (cohort 1, n=90; cohort 2, n=23) were enrolled. Median age was 54 yr (range: 34-79), 25.6% (n=29) of pts had received ≥4 prior systemic chemotherapy lines, and 54.0% (n=61) of pts had an ECOG score of 1 at study entry. At data cutoff, median follow-up was 12.2 mo (range: 0.2-21.5). Across both cohorts, pamiparib showed preliminary antitumor activity (Table). In cohort 1, confirmed ORRIRC was 64.6%, median DoR was 14.5 mo (95% CI, 11.1-NE), progression-free survival (PFS) was 15.2 mo (95% CI, 10.35-NE), and median overall survival (OS) was not yet mature. In cohort 2, confirmed ORRIRC was 31.6%, median DoR was 11.1 mo (95% CI, 4.21-NE), median PFS was 6.2 mo (95% CI, 4.11-NE), and median OS was 13.6 mo (95% CI, 7.13-NE). Overall, the most common treatment-related AE was anemia (any grade, 89%; grade ≥3, 42%); following a per-protocol proposed dose modification algorithm, the incidence of grade ≥3 anemia was reduced to 25.6%. Table: 820P

Efficacy-evaluable population Cohort 1 (n=82) Cohort 2 (n=19)
Best overall response, n (%)
Complete response 8 (9.8) 0 (0)
Partial response 45 (54.9) 6 (31.6)
Stable disease 25 (30.5) 12 (63.2)
Progressive disease 4 (4.9) 1 (5.3)
Objective response rate, % (95% CI)
Confirmed 64.6 (53.3-74.9) 31.6 (12.6-56.6)
Disease control rate, % (95% CI) 95.1 (88.0-98.7) 94.7 (74.0-99.9)
Clinical benefit rate, % (95% CI) 74.4 (63.6-83.4) 52.6 (28.9-75.6)
Time to response, median mo (range) 1.68 (1.3-6.3) 1.38 (1.2-1.4)
Duration of response, median mo (95% CI) 14.5 (11.1-NE) 11.1 (4.21-NE)
PFS, median mo (95% CI) 15.2 (10.35-NE) 6.2 (4.11-NE)

Abbreviations: NE, not estimable; PFS, progression-free survival.

Conclusions

Promising antitumor activity was observed in pts with platinum-sensitive/resistant aOC. Pamiparib was generally tolerated, with no new safety signals. Pamiparib is being evaluated as monotherapy and combination therapy for other solid tumors.

Clinical trial identification

NCT03333915.

Editorial acknowledgement

Writing and editorial assistance was provided by Regina Switzer, PhD, Cathy R. Winter, PhD, and Elizabeth Hermans, PhD (OPEN Health Medical Communications, Chicago. IL), and funded by the study sponsor.

Legal entity responsible for the study

BeiGene, Ltd.

Funding

BeiGene, Ltd.

Disclosure

X. Wu, J. Wang, B. Kong, R. Yin, W. Sun, Q. Zhou, S. Zhang, D. Wang, H. Shi, Y. Gao, Y. Huang, G. Li, X. Wang: Research grant/Funding (institution): BeiGene, Ltd. L. Li, X. Mu, M. Li: Shareholder/Stockholder/Stock options, Full/Part-time employment: BeiGene, Ltd. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings