Efficacy of niraparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer in phase 3 PRIME study: A subgroup analysis by response to first-line platinum-based chemotherapy.

Authors

null

Rutie Yin

Department of Gynecology and Obstetrics, and Key Laboratory of Obstetrics and Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China

Rutie Yin , Ning Li , Lingying Wu , Jing Wang , Jianqing Zhu , Lingya Pan , Beihua Kong , Hong Zheng , Jihong Liu , Xiaohua Wu , Li Wang , Yi Huang , Ke Wang , Dongling Zou , Hongqin Zhao , Chunyan Wang , Weiguo Lu , Xiaoa Zhen , Wenzhao Hang , Jianmei Hou

Organizations

Department of Gynecology and Obstetrics, and Key Laboratory of Obstetrics and Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, Hunan Cancer Hospital, Changsha, China, Cancer Hospital of the University of Chinese Academy of Sciences /Zhejiang Cancer Hospital, Hangzhou, China, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China, Qilu Hospital of Shandong University, Jinan, China, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gynecologic Oncology, Peking University Cancer Hospital & Institute, Beijing, China, Sun Yat-sen University Cancer Center, Guangzhou, China, Fudan University Shanghai Cancer Center, Shanghai, China, Henan Cancer Hospital, Zhenzhou, China, Hubei Cancer Hospital, Wuhan, China, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, Gynecological Oncology Center, Chongqing University Cancer Hospital, Chongqing, China, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China, Liaoning Cancer Hospital & Institute, Shenyang, China, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China, Zai Lab (US) LLC, Boston, MA, Zai Lab (Shanghai) Co., Ltd, Shanghai, China

Research Funding

Other Foundation

Background: In PRIME (NCT03709316), niraparib significantly reduced the risk of disease progression or death versus placebo (PBO) (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.34–0.60) in Chinese patients (pts) with newly diagnosed, advanced ovarian cancer (OC), regardless of biomarker status. As response to chemotherapy is deemed to be associated with prognosis in OC, this subgroup analysis of the PRIME study aims to better understand niraparib treatment effect in pts based on response to first-line platinum-based chemotherapy (1L CT). Methods: This randomized, double-blind, PBO-controlled, phase 3 trial enrolled adults with newly diagnosed, stage III or IV OC who achieved a complete response (CR) or partial response (PR) to 1L CT and received primary or interval cytoreductive surgery, irrespective of residual disease status after surgery. Pts were randomized (2:1) to receive niraparib or PBO, whose starting doses were individualized based on baseline bodyweight and platelet count, with stratification according to status of germline BRCA mutations (yes or no), tumor homologous recombination status (deficient or proficient), receipt of neoadjuvant chemotherapy (yes or no), and clinical response to 1L CT (CR or PR). This prespecified exploratory analysis reports progression-free survival (PFS) and HRs based on clinical response to 1L CT. The data cut-off date was 30 September 2021. Results: Of the 384 pts randomized, 315 (82.0%) and 69 (18.0%) had a CR (212 niraparib, 103 PBO) or PR (43 niraparib, 26 PBO) to 1L CT, respectively. Baseline characteristics are presented in the Table. The overall PFS median follow-up was 27.5 months. Niraparib significantly extended PFS compared with PBO: the median PFS was 29.4 months for niraparib versus 8.3 months for PBO (HR=0.45; 95% CI, 0.32–0.61; P<0.001) in the CR group and was 19.3 months for niraparib versus 8.3 months for PBO (HR=0.45; 95% CI, 0.23–0.86; P=0.014) in the PR group. Conclusions: In pts with newly diagnosed advanced OC, PFS was substantially prolonged with niraparib versus PBO, regardless of response to chemotherapy and biomarker status. Moreover, pts who achieved a CR appeared to receive larger PFS benefit from niraparib than those with a PR. Clinical trial information: NCT03709316.

Baseline characteristics.

Complete responsePartial response
Characteristic, n (%)Niraparib (N=212)
Placebo
(N=103)
Niraparib
(N=43)
Placebo
(N=26)
FIGO stage
III
156 (73.6)
79 (76.7)
26 (60.5)
15 (57.7)

IV
56 (26.4)
24 (23.3)
17 (39.5)
11 (42.3)
Neoadjuvant chemotherapy
Yes
100 (47.2)
48 (46.6)
21 (48.8)
11 (42.3)
No
112 (52.8)
55 (53.4)
22 (51.2)
15 (57.7)
Germline BRCA mutations
Yes
67 (31.6)
32 (31.1)
18 (41.9)
8 (30.8)
No
145 (68.4)
71 (68.9)
25 (58.1)
18 (69.2)
Residual disease status after surgery
Optimal
167 (78.8)
86 (83.5)
26 (60.5)
19 (73.1)
Suboptimal or missing
45 (21.2)
17 (16.5)
17 (39.5)
7 (26.9)

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT03709316

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 5551)

DOI

10.1200/JCO.2022.40.16_suppl.5551

Abstract #

5551

Poster Bd #

430

Abstract Disclosures