FDA Approves Zejula (niraparib) as the Only Once-Daily PARP Inhibitor in First-Line Monotherapy Maintenance Treatment for Women with Platinum-Responsive Advanced Ovarian Cancer Regardless of Biomarker Status
London UK -- 29 April 2020 -- Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress.”
Zejula is the only once-daily PARP inhibitor approved in the US as monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first-line and recurrent maintenance treatment settings, as well as late-line primary treatment settings.
Dr. Bradley Monk, PRIMA investigator, US Oncology, University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph's Hospital Phoenix, said: “PRIMA was designed for patients with ovarian cancer who have a high unmet need. The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population. This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance.”
The primary endpoint in the PRIMA study was progression-free survival (PFS) analysed sequentially, first in the homologous recombination deficient (HRd) population, then in the overall population. The PRIMA study significantly improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula resulted in a 57% reduction in the risk of disease progression or death vs. placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001), and a 38% reduction in the risk of disease progression or death vs. placebo in the overall population (HR 0.62; 95% CI, 0.50 to 0.76; p<0.0001).
Zejula’s safety profile, as demonstrated by the PRIMA results, was consistent with clinical trial experience. The most common grade 3 or higher adverse events with Zejula included thrombocytopenia (39%), anaemia (31%) and neutropenia (21%).
At initiation of the PRIMA study, patients received a fixed starting dose of 300 mg of Zejula once-daily. The study was later amended to incorporate an individualised starting dose of either 200 mg or 300 mg of Zejula once-daily based on the patient’s baseline weight and/or platelet count. Lower rates of grade 3 and 4 haematologic treatment-emergent adverse events were observed with an individualised starting dose, compared to the overall population, including thrombocytopenia (21% compared to 39%), anaemia (23% compared to 31%) and neutropenia (15% compared to 21%).
“It’s so important for patients with ovarian cancer to have treatment options, and this approval is positive news for our community,” said Audra Moran, President and CEO, Ovarian Cancer Research Alliance. “PARP inhibitors represent a major advancement in the fight against ovarian cancer, and having a new first-line maintenance option for platinum-responsive advanced ovarian cancer patients — regardless of BRCA mutation status — is especially exciting. We are determined to keep funding research and partnering with scientists who are on the frontline of finding new treatments like this one to help those impacted by this disease.”
PRIMA study results were previously presented at the 2019 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine.
Zejula is not approved for use in first-line maintenance treatment outside the US.
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About Ovarian Cancer
In the US, ovarian cancer impacts nearly 222,000 women annually,[ii] and it is the fifth most frequent cause of cancer death among women.[iii] Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.[iv] Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.
About Zejula (niraparib)
Niraparib is an oral, once-daily PARP inhibitor that is currently being evaluated in multiple pivotal trials. GSK is building a robust niraparib clinical development programme by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics. The ongoing development programme for niraparib includes several combination studies, including a phase III study as a first-line triplet maintenance treatment in ovarian cancer (FIRST).
GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cell therapy, either alone or in combination.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.
- [i] Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D'Andrea AD. Homologous Recombination Deficiency: Exploiting the Fundamental Vulnerability of Ovarian Cancer. Cancer Discov. 2015; 5(11): 1137-54.
- [ii] SEER Cancer Stat Facts: Ovarian Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed October 10, 2018.
- [iii] American Cancer Society “Key Statistics for Ovarian Cancer.” https://www.cancer.org/cancer/ovarian-cancer/about/key-statistics.html
- [iv] Lorusso D, Mancini M, Di Rocco R, Fontanelli R, Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer [published online August 5, 2012]. Int J Surg Oncol. 2012. doi:10.1155/2012/613980
Posted: April 2020
- FDA Approves Additional Indication for Zejula (niraparib) for Late-line Treatment for Women with Recurrent Ovarian Cancer - October 23, 2019
- Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer - March 27, 2017
- Tesaro Announces Priority Review Designation for Niraparib NDA - December 20, 2016
- Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer - November 1, 2016
- Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission - September 12, 2016
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