- Results demonstrate ZEJULA activity beyond patients with BRCA mutations in late-line ovarian cancer treatment setting
- QUADRA data accepted for presentation at 2018
- Data intended to support label expansion with biomarker in the treatment setting
Previous studies have shown PARP inhibitor activity in the late-line treatment of patients with BRCA mutations. QUADRA, a single arm study (n=461), was conducted to assess the activity of ZEJULA monotherapy in the fourth-line plus treatment of specific ovarian cancer patient populations. Of the 92% of QUADRA participants who were PARP inhibitor naïve, 15% had a BRCA mutation, over two-thirds were platinum resistant/refractory and 63% had received prior bevacizumab.
ZEJULA demonstrated activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive (n=45), with an objective response rate (ORR) of 29%, and duration of response (DOR) of 9.2 months. In patients who were fourth line or greater with BRCA mutations, including platinum-sensitive, resistant and refractory, (n=55), the ORR was 31% and the median DOR was 9.4 months.
At a starting dose of 300 milligrams of ZEJULA, the most commonly observed adverse events were consistent with prior clinical experience and included myelosuppression, which was generally managed via dose modifications.
“These results demonstrated that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations, which is the only treatment setting in which PARP inhibitors are approved today. In addition, the QUADRA data describe ZEJULA monotherapy activity in platinum-resistant/refractory patients, providing important context for our TOPACIO study of ZEJULA in combination with an anti-PD-1 inhibitor,” said
Beyond QUADRA, clinical trials of niraparib in ovarian cancer include:
- PRIMA: Monotherapy Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status expected to complete enrollment in Q2 2018; data anticipated in 2019
- OVARIO: Combination Phase 2 trial assessing ZEJULA with bevacizumab for patients with newly diagnosed ovarian cancer
- FIRST: Combination Phase 3 clinical trial of chemotherapy ± TSR-042, and ZEJULA in first-line ovarian cancer to be initiated in 1H 2018
- NOVA: Monotherapy Phase 3 trial for patients with platinum sensitive, recurrent ovarian cancer, regardless of biomarker status (complete; patients being followed for overall survival)
- AVANOVA: Combination Phase 2 trial with bevacizumab for patients with recurrent ovarian cancer; anticipate data to be available in 2H 2018 to support data submission for a meeting held in 2019
- TOPACIO: Combination Phase 2 trial with anti-PD-1 for patients with platinum-resistant ovarian cancer or triple negative breast cancer (abstracts accepted for presentation at
- A tablet formulation of ZEJULA is in development.
About the QUADRA Clinical Trial
QUADRA is an open-label, single arm trial designed to evaluate the safety and efficacy of ZEJULA in the treatment setting of ovarian cancer. Patients were enrolled and received a starting dose of 300 milligrams of niraparib once per day. The primary endpoint of this study was objective response rate (ORR) per RECIST in the fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive. Other endpoints include durability of response, disease control rate, progression free survival (PFS), overall survival (OS) and safety and tolerability.
About ZEJULA® (Niraparib)
Niraparib is marketed in
ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.
Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.
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Source: TESARO, Inc.