GlaxoSmithKline plc GSK announced that the late-stage study evaluating its newly acquired PARP inhibitor — Zejula (niraparib) — for an expanded patient population met its primary endpoint. The phase III PRIMA study evaluated the efficacy of Zejula as a maintenance therapy in women with first-line ovarian cancer, who had received platinum-based chemotherapy.
Data from the study showed that treatment with Zejula led to a statistically significant improvement in progression free survival for women, regardless of their biomarker status, thereby meeting the study’s primary endpoint.
The safety and tolerability profile of Zejula was similar to the previous studies. Glaxo plans to present complete results from the PRIMA study at an upcoming scientific conference.
Zejula was approved in 2017 as a maintenance treatment for patients with recurrent ovarian cancer.
Shares of Glaxo have rallied 7% so far this year against the industry’s decrease of 1.5%.
Apart from the PRIMA study, Zejula is being evaluated in the pivotal phase III BRAVO study to treat patients with germline BRCA-mutated, metastatic breast cancer and a registrational phase II QUADRA study for the treatment of ovarian cancer.
The drug is also being examined in several combination studies. Zejula in combination with Merck’s MRK anti-PD-1 inhibitor, Keytruda (pembrolizumab), is being studied for treating metastatic triple-negative breast cancer and advanced platinum-resistant ovarian cancer. Moreover, Zejula plus Roche’s RHHBY Avastin (bevacizumab) is being studied in patients with recurrent, platinum-sensitive ovarian cancer.
Last month, the FDA granted priority review to Glaxo’s supplemental new drug application (sNDA), looking to expand Zejula’s label for treating ovarian cancer in patients who have received three or more chemotherapy regimens. The FDA is expected to make a decision on Oct 24, 2019.
Notably, Zejula was added to Glaxo’s portfolio following the acquisition of Tesaro in January this year. The drug generated sales of £42 million in the first quarter of 2019. If the drug is approved in the first-line setting, the company will gain access to a broader patient population, which will further boost its sales.
Other PARP inhibitors available in the market are AstraZeneca/Merck’s Lynparza, which won FDA nod in the first-line maintenance setting for ovarian cancer last December, and Clovis Oncology, Inc.’s CLVS Rubraca, which is being evaluated in late-stage studies in the first-line maintenance setting in ovarian cancer patients.
Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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