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ENGOT-OV16/NOVA: Niraparib Maintenance According to Complete or Partial Response to Platinum Chemotherapy for Recurrent Ovarian Cancer

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Key Points

  • Niraparib maintenance improved progression-free survival vs placebo among patients with partial or complete responses to platinum-based chemotherapy.
  • Benefits were observed in both the germline BRCA mutation and non–germline BRCA mutation cohorts.

In an analysis of the phase III ENGOT-OV16/NOVA trial in recurrent ovarian cancer reported in the Journal of Clinical Oncology, del Campo et al found that patients had clinical benefit from niraparib maintenance vs placebo irrespective of whether they had a partial response or complete response to their last platinum-based regimen.

The trial enrolled patients with a partial or complete response to platinum-based chemotherapy, with niraparib maintenance prolonging progression-free survival vs placebo among all patients.

Study Details

A total of 553 patients were enrolled in the trial. Of 203 with a germline BRCA mutation, 99 had a partial response and 104 had a complete response to their last platinum-based therapy. Of 350 without a confirmed germline BRCA mutation, 173 had a partial response and 177 had a complete response.

A post hoc analysis was performed to determine risk of progression according to germline BRCA mutation status and complete or partial response to last platinum-based therapy.

Progression-Free Survival Benefit

Progression-free survival was improved in patients treated with niraparib vs placebo in the germline BRCA mutation cohort, with hazard ratios of 0.24 (P < .0001) among those with a partial response and 0.30 (P < .0001) among those with a complete response. Similarly, progression-free survival was improved with niraparib in the non–germline BRCA mutation cohort, with hazard ratios of 0.35 (P < .0001) among those with a partial response and 0.58 (P = .0082) among those with a complete response.

The investigators concluded, “Patients achieved clinical benefit from maintenance treatment with niraparib, regardless of response to the last platinum-based therapy.”

Mansoor R. Mirza, MD, of Rigshospitalet–Copenhagen University Hospital, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by TESARO: A GSK Company. For full disclosures of the study authors, visit jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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