MedicalResearch.com Interview with:
Dr. Mansoor Raza Mirza, MD
Medical Director: Nordic Society of Gynecologic Oncology
Board of Directors: Gynecologic Cancer Inter-Group (GCIG)
Faculty: European Society of Medical Oncology (ESMO)
Faculty: International Gynecologic Cancer Society (IGCS)
Chief Oncologist, Rigshospitalet
Copenhagen University Hospital
MedicalResearch.com: What is the background for this study?
Response: Recurrent ovarian cancer is an area of significant unmet medical need, and there have been few therapeutic advances for these patients in the past few decades.
Niraparib was studied to provide patients with recurrent ovarian cancer an option other than “watchful waiting,” potentially redefining the standard of care for the disease. The ENGOT-OV16/NOVA trial was a Phase 3 double-blind, randomized, placebo-controlled international study of maintenance treatment with niraparib compared with placebo. Niraparib successfully achieved the primary endpoint of prolonging progression-free survival versus placebo in all three prospectively defined primary efficacy populations:
MedicalResearch.com: What are the main findings?
Response: The primary efficacy results were as follows:
- In patients who are germline BRCA mutation carriers, the niraparib arm achieved a median progression free survival of 21 months versus 5.5 months for patients in the placebo arm, a difference of 15.5 months (HR= 0.27; [95% CI, 0.17-0.41] p=<0.0001)
- In patients who are not germline BRCA mutation carriers, the niraparib arm achieved a median progression free survival of 9.3 months versus 3.9 months for patients in the placebo arm, a difference of 5.4 months (HR = 0.45; 95% CI, 0.34-0.61; p=<0.0001)
- In patients who are not germline BRCA mutation carriers, but who have homologous recombination deficient tumors, the niraparib arm achieved a median progression free survival of 12.9 months versus 3.8 months for patients in the placebo arm, a difference of 9.1 months (HR = 0.38; 95% CI, 0.24-0.59; p=<0.0001).
MedicalResearch.com: What should readers take away from your report?
Response: There are limited treatment options in recurrent ovarian cancer. The effectiveness of platinum-based chemotherapy diminishes over time, and PFS and platinum-free intervals generally become shorter after each round of platinum treatment. In addition, the incidence of infection and risk of neuropathy and hypersensitivity with certain chemotherapy agents rises with subsequent cycles.
Niraparib significantly improved progression-free survival across a broad patient population representing 70% of all ovarian cancer patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future studies are needed to help identify which patients would benefit most from niraparib treatment and why. Niraparib is also being tested in other ovarian cancer treatment settings and combinations, as well as in breast cancer.
MedicalResearch.com: Is there anything else you would like to add?
Response: No maintenance therapy for ovarian cancer is approved in the United States. An oral maintenance treatment that could lengthen the PFS interval between rounds of platinum-based chemotherapy would be very meaningful for patients with ovarian cancer, who often live with a fear of recurrence after ending active treatment.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer
Mansoor R. Mirza, M.D., Bradley J. Monk, M.D., Jørn Herrstedt, M.D., D.M.Sc., Amit M. Oza, M.D., Sven Mahner, M.D., Andrés Redondo, M.D., Ph.D., Michel Fabbro, M.D., Jonathan A. Ledermann, M.D., Domenica Lorusso, M.D., Ignace Vergote, M.D., Ph.D., Noa E. Ben-Baruch, M.D., Christian Marth, M.D., Radosław Mądry, M.D., Ph.D., René D. Christensen, Ph.D., Jonathan S. Berek, M.D., Anne Dørum, M.D., Ph.D., Anna V. Tinker, M.D., Andreas du Bois, Ph.D., M.D., Antonio González-Martín, M.D., Philippe Follana, M.D., Benedict Benigno, M.D., Per Rosenberg, M.D., Ph.D., Lucy Gilbert, M.D., Bobbie J. Rimel, M.D., Joseph Buscema, M.D., John P. Balser, Ph.D., Shefali Agarwal, M.D., M.P.H., and Ursula A. Matulonis, M.D., for the ENGOT-OV16/NOVA Investigators*
October 8, 2016
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