Ursula A. Matulonis, MD
Niraparib (Zejula) demonstrated durable antitumor activity in patients with heavily pretreated homologous recombinant deficiency (HRD)-positive ovarian cancer, according to data from the phase II QUADRA trial.
, Matulonis, chief of the Gynecological Oncology Division at Dana-Farber Cancer Institute and professor of Medicine at Harvard Medical School, highlighted the activity and tolerability of niraparib and discussed other recent data in ovarian cancer.
OncLive: Please provide some background to the QUADRA study.
: The rationale for QUADRA was really to expand the use of the oral PARP inhibitor niraparib into patient populations beyond where it's currently FDA approved. Currently, it is FDA approved for maintenance therapy in women who have responded to platinum-based chemotherapy and have recurrent disease. In order to prolong that maintenance and that remission they have achieved, the FDA granted approval to niraparib as a very broad label. Using niraparib following chemotherapy at a dose of 300 mg—so once somebody's blood counts have come back up to normal—they're ready to go on a PARP inhibitor.
What was the study design?
This is a very large trial looking at single-agent niraparib in more heavily pretreated populations. The total number of participants enrolled was 463, and after a little more than 300 women had been enrolled, an amendment was then issued stating that patients were limited to 3 or 4 prior lines of therapy and they had to have an initial response to chemotherapy. This was to ensure that their disease had some susceptibility to drugs such as PARP inhibitors.
What were the data presented at the 2018 ASCO Annual Meeting?
The full data issued really looked at the primary endpoint, which was ORR in heavily pretreated patients with HRD-positive ovarian cancer. There was a 29% ORR, and this is exciting because these are patients with few options once they get to the fourth-line setting and beyond. Overall, this is a good thing.
Are there any additional data you would like to mention?
Other results being presented are around the germline BRCA
-mutated cohort. This is a subgroup of patients with underlying BRCA
mutations. In that population of heavily pretreated women with 3 or 4 prior lines of therapy, there are excellent response rates. In these women with platinum-sensitive disease, there was a little greater than 40% ORR, which is very impressive. For patients with platinum-resistant cancer, it was still very good at around 25% ORR. Overall for the BRCA
-mutated group, the ORR was close to 30%.
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