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Pamiparib Monotherapy for Patients With Germline BRCA1/2-Mutated Ovarian Cancer Previously Treated With at Least Two Lines of Chemotherapy: A Multicenter, Open-Label, Phase II Study.

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机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [2]Department of Gynecologic Oncology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China. [3]Department of Gynecology and Oncology, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [4]Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. [5]Department of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, West China Second Hospital, Sichuan University, Chengdu, China. [6]Department of Gynecologic Oncology, Anhui Provincial Cancer Hospital, The First Affiliated Hospital of USTC, Hefei, China. [7]Department of Gynecologic Oncology, Chongqing University Cancer Hospital & Chongqing Cancer Institute & Chongqing Cancer Hospital, Chongqing, China. [8]Department of Gynecologic Oncology, The First Hospital of Jilin University, Changchun, China. [9]Department of Gynecology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, Liaoning, People’s Republic of China. [10]Department of Obstetrics and Gynecology, First Affiliated Hospital, Dalian Medical University, Dalian, China. [11]Department of Gynecological Oncology, Peking University School of Oncology, Beijing Cancer Hospital, Beijing Institute for Cancer Research, Beijing, China. [12]Department of Gynecological Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [13]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [14]Department of Oncology and Hematology, The Second Hospital of Jilin University, Changchun, China. [15]Department of Medical Oncology, Jilin Cancer Hospital, Changchun, China. [16]Department of Gynecology, Harbin Medical University Cancer Hospital, Harbin, China. [17]Department of Obstetrics and Gynecology, Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China. [18]Department of Gynecological Oncology, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, China. [19]Department of Oncology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China. [20]Department of Gynecologic Oncology, Maternal and Child Health Hospital of Jiangxi Province, Nanchang, Jiangxi, China. [21]Department of Clinical Development, BeiGene, Ltd., Shanghai, China. [22]Department of Biostatistics, BeiGene, Ltd., Beijing, China. [23]Department of Clinical Development, BeiGene, Ltd., Beijing, China. [24]Department of Clinical Pharmacology, BeiGene USA, Inc., San Mateo, California. [25]Department of Obstetrics and Gynecology, Qilu Hospital of Shandong University, Ji’nan, China.

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Phase I results of this phase I/II study showed that pamiparib 60 mg BID had antitumor activity and an acceptable safety profile in Chinese patients with advanced cancer, including epithelial ovarian cancer (OC).This open-label phase II study was conducted in China and enrolled adult ({greater than or equal to}18 years) patients with platinum-sensitive OC (PSOC, disease progression occurring {greater than or equal to}6 months after last platinum treatment) or platinum-resistant OC (PROC, disease progression occurring <6 months after last platinum treatment). Eligible patients had known or suspected deleterious germline BRCA mutation (gBRCA mut) and had previously received {greater than or equal to}2 lines of therapy. Pamiparib 60 mg PO BID was administered until disease progression, toxicity, or patient withdrawal. The primary endpoint was objective response rate (ORR) assessed by independent review committee (IRC) per RECIST version 1.1.In the total patient population (N=113; PSOC, n=90; PROC, n=23), median age was 54 years (range, 34-79) and 25.6% of patients received {greater than or equal to}4 prior systemic chemotherapy lines. Median study follow-up was 12.2 months (range, 0.2-21.5). Eighty-two PSOC patients and 19 PROC patients were evaluable for efficacy. In PSOC patients, 8 achieved a complete response (CR) and 45 achieved a partial response (PR); ORR was 64.6% (95% CI, 53.3-74.9). In PROC patients, 6 achieved a PR; ORR was 31.6% (95% CI, 12.6-56.6). Frequently reported grade {greater than or equal to}3 adverse events (AEs) were hematologic toxicities, including anemia and decreased neutrophil count.Pamiparib 60 mg BID showed antitumor activity with durable responses in patients with PSOC or PROC with gBRCA mut, and had a manageable safety profile.

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大类 | 1 区

医学

小类 | 1 区肿瘤学

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

第一作者：

第一作者机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [*1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.

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通讯机构： [1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. [*1]Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.

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