Aikou Okamoto1, Eiji Kondo2, Toshiaki Nakamura3, Satoshi Yanagida1, Junzo Hamanishi4, Kenichi Harano5, Kosei Hasegawa6, Takeshi Hirasawa7, Kensuke Hori8, Shinichi Komiyama9, Motoki Matsuura10, Hidekatsu Nakai11, Hiroko Nakamura12, Jun Sakata13, Tsutomu Tabata14, Kazuhiro Takehara15, Munetaka Takekuma16, Yoshihito Yokoyama17, Yoichi Kase18, Shuuji Sumino19, Junpei Soeda20, Ajit Suri21, Daisuke Aoki22, Toru Sugiyama23. 1. Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan. 2. Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, Tsu, Japan. 3. Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima, Japan. 4. Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine, Kyoto, Japan. 5. Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 6. Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan. 7. Department of Obstetrics and Gynecology, Tokai University School of Medicine, Isehara, Japan. 8. Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki, Japan. 9. Department of Obstetrics and Gynecology, Toho University Faculty of Medicine, Tokyo, Japan. 10. Department of Obstetrics and Gynecology, Sapporo Medical University, Sapporo, Japan. 11. Department of Obstetrics and Gynecology, Kindai University Faculty of Medicine, Osakasayama, Japan. 12. Department of Obstetrics and Gynecology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Japan. 13. Gynecologic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan. 14. Department of Obstetrics and Gynecology, Tokyo Women's Medical University, Tokyo, Japan. 15. Department of Gynecologic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. 16. Department of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan. 17. Department of Obstetrics and Gynecology, Graduate School of Medicine, Hirosaki University, Hirosaki, Japan. 18. Oncology Clinical Research Department, Oncology Therapeutic Area Unit for Japan and Asia, Takeda Pharmaceutical Company Limited, Osaka, Japan. 19. Biostatistics, Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan. 20. Department of Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan. 21. Millennium Pharmaceuticals, Inc., Cambridge, MA, USA. 22. Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan. aoki@z7.keio.jp. 23. Department of Obstetrics and Gynecology, St. Mary Hospital, Fukuoka, Japan.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. METHODS: This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. RESULTS: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. CONCLUSION: Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759600.
OBJECTIVE: To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. METHODS: This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. RESULTS: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. CONCLUSION: Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759600.