Olaparib Maintenance Monotherapy in Asian Patients with Platinum-Sensitive Relapsed Ovarian Cancer: Phase III Trial (L-MOCA)

Gao Q 1 , Zhu J 2 , Zhao W 3 , Huang Y 4 , An R 5 , Zheng H 6 Show all authors , Qu P 7 , Wang L 8 , Zhou Q 9 , Wang D 10 , Lou G 11 , Wang J 12 , Wang K 13 , Low J 14 , Kong B 15 , Rozita AM 16 , Sen LC 17 , Yin R 18 , Xie X 19 , Liu J 20 , Sun W 3 , Su J 21 , Zhang C 21 , Zang R 22 , Ma D 1

Affiliations 

  • 1 Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, Wuhan, China
  • 2 Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China
  • 3 Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, Hefei, China
  • 4 Department of Gynecologic Oncology, Hubei Cancer Hospital, Wuhan, China
  • 5 Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
  • 6 Department of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital, Beijing, China
  • 7 Department of Gynecology Oncology, Tianjin Central Hospital of Gynecology Obstetrics, Tianjin, China
  • 8 Department of Gynecologic Oncology, Affiliated Cancer Hospital of Zhengzhou University, (Henan Cancer Hospital), Zhengzhou, China
  • 9 Department of Gynecologic Oncology, Chongqing University Cancer Hospital, Chongqing, China
  • 10 Department of Gynecologic Oncology, Liaoning Cancer Hospital, Shenyang, China
  • 11 Department of Gynecologic Oncology, Harbin Medical University Cancer Hospital, Harbin, China
  • 12 Department of Gynecologic Oncology, Hunan Cancer Hospital, Changsha, China
  • 13 Department of Gynecologic Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
  • 14 Cancer Centre @ PHKL, Pantai Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
  • 15 Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Jinan, China
  • 16 Clinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia
  • 17 Oncology Department, Hospital Sultan Ismail, Johor Bahru, Malaysia
  • 18 Department of Obstetrics and Gynecology, West China Second University Hospital, Chengdu, China
  • 19 Department of Gynecologic Oncology, Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China
  • 20 Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China
  • 21 Department of Medical Affairs, AstraZeneca, Shanghai, China
  • 22 Department of Gynaecologic Oncology, Zhongshan Hospital, Fudan University, Shanghai, China
Clin Cancer Res, 2022 Jun 01;28(11):2278-2285.
PMID: 35131903 DOI: 10.1158/1078-0432.CCR-21-3023

Abstract

PURPOSE: In patients with platinum-sensitive relapsed (PSR) ovarian cancer, olaparib maintenance monotherapy significantly improves progression-free survival (PFS) versus placebo. However, evidence in the Asian population is lacking. This is the first study to evaluate olaparib efficacy and tolerability exclusively in Asian patients with PSR ovarian cancer.

PATIENTS AND METHODS: Considering the limited placebo effect and significant clinical benefit of olaparib in previous trials, and the rapid approval of olaparib in China, this phase III study was designed as an open-label, single-arm trial. Patients with high-grade epithelial PSR ovarian cancer were enrolled from country-wide clinical centers across China and Malaysia. Patients received oral olaparib (300 mg) twice daily until disease progression or unacceptable toxicity. Primary endpoint was median PFS (mPFS). Primary analysis of PFS using the Kaplan-Meier method was performed when data reached 60% maturity (clinicaltrials.gov NCT03534453).

RESULTS: Between 2018 and 2020, 225 patients were enrolled, and 224 received olaparib; 35.7% had received ≥3 lines of chemotherapy, 35.3% had achieved complete response to their last line of platinum-based chemotherapy, and 41.1% had a platinum-free interval ≤12 months. At primary data cut-off (December 25, 2020), overall mPFS was 16.1 months; mPFS was 21.2 and 11.0 months in BRCA-mutated and wild-type BRCA subgroups, respectively. Adverse events (AE) occurred in 99.1% of patients (grade ≥3, 48.7%); 9.4% discontinued therapy due to treatment-related AEs.

CONCLUSIONS: Olaparib maintenance therapy was highly effective and well tolerated in Asian patients with PSR ovarian cancer, regardless of BRCA status. This study highlights the promising efficacy of olaparib in this Asian population. See related commentary by Nicum and Blagden, p. 2201.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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