Zai Lab (ZLAB) announced completion of patient enrollment of its pivotal trial of niraparib, or Zejula in development for second-line maintenance therapy in patients with recurrent, platinum-sensitive ovarian cancer. The Phase 3 trial is evaluating niraparib as a second-line maintenance therapy in patients with recurrent platinum-sensitive ovarian cancer. Recurrent ovarian cancer patients who have responded to a platinum-containing regimen were enrolled in the study and randomized 2:1 to receive either niraparib or placebo once daily. Patients were stratified by gBRCA status. The primary endpoint is progression-free survival. The study enrolled its first patient in September 2017. Zai Lab in-licensed rights to Zejula from Tesaro (TSRO) for China, Hong Kong and Macau as an important, new treatment option to more than 50,000 Chinese patients who suffer from ovarian cancer every year. Zejula is positioned as a PARP inhibitor due to its efficacy, once-daily dosing and pharmacokinetic properties including its ability to cross the blood brain barrier. The NDA was accepted by the NMPA in December 2018. Zai Lab obtained approval for marketing Zejula in Hong Kong in October and launched the product in December 2018. Niraparib is also being evaluated in China in pivotal studies as first-line maintenance therapy in platinum-sensitive ovarian cancer and in small-cell lung cancer.
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