Overall survival (OS) in patients with platinum-sensitive relapsed ovarian cancer (PSROC) treated with olaparib maintenance monotherapy: Update from the L-MOCA trial.
Year: 2024
Type: conference-abstract
Abstract: 5559 Background: The open-label, single-arm, L-MOCA trial (NCT03534453) was the first study to demonstrate promising efficacy and tolerability of olaparib maintenance monotherapy in Asian patients with PSROC (median progression-free survival 16.1 months). Here we report the interim OS analysis. Methods: The study enrolled Asian patients with high-grade epithelial PSROC who had received ≥2 prior lines (L) of platinum-based chemotherapy and achieved complete or partial response. Patients were treated with oral olaparib (300 mg) twice daily until disease progression or unacceptable toxicity. A prespecified descriptive analysis of OS, a secondary endpoint, was conducted after approximately 3 years of follow-up. OS was analyzed in the full analysis set (FAS; defined as patients who received olaparib) and in subgroups defined by biomarker status ( BRCAmutation /homologous recombination deficiency (HRD) status) and prior L of anticancer therapy. Results: By the date of data cutoff (16 Nov 2023), the median duration of follow-up was 40.0 months (range 0.5–64.2); 105 (46.9%) deaths occurred. In the FAS (N=224), the median OS was 54.4 months (95% CI 43.8–not evaluable [NE]). Median OS was not reached (NR; 51.9–NE) in the BRCA mutant ( BRCAm) subgroup and 44.3 months (34.8–59.1) in the BRCA wild-type ( BRCAwt) subgroup. In patients who had tumors with HRD, median OS was 59.1 (43.5–NE); among them, patients with HRD BRCAwt showed a median OS of 54.6 months (33.0–NE); in the homologous recombination proficiency (HRP) subgroup, median OS was 37.2 months (28.3–56.1). Adverse events of any grade occurred in 222 (99.1%) patients. The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low (3 [1.3%]). No new safety signals were identified. Conclusions: Olaparib showed promising OS benefit in Asian patients with PSROC, regardless of the BRCA mutation or HRD status, with a well-tolerated safety profile. Clinical trial information: NCT03534453 . [Table: see text]
Source: Journal of Clinical Oncology
Institutions: Tongji Hospital, Huazhong University of Science and Technology, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou Cancer Hospital, Hubei Cancer Hospital, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an Jiaotong University, Peking University Cancer Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Zhengzhou University, Henan Cancer Hospital, Chongqing University, Liaoning Cancer Hospital & Institute, Harbin Medical University, Hunan Cancer Hospital, Pantai Hospital, Kuala Lumpur, Shandong University, Qilu Hospital of Shandong University, West China Second University Hospital of Sichuan University, Women's Hospital, School of Medicine, Zhejiang University, Zhejiang University, Sun Yat-sen University, Sun Yat-sen University Cancer Center, Fudan University, Zhongshan Hospital
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4399395083