The FDA approved Tesaro’s once-daily, oral poly(ADP ribose) polymerase (PARP) inhibitor Zejula™ (niraparib) for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who demonstrated a partial or complete response to platinum-based therapy. The firm claims the drug is the first FDA-approved PARP inhibitor for the maintenance treatment of recurrent ovarian cancer, and also the only FDA-approved PARP inhibitor that doesn’t require BRCA mutation or other biomarker testing. 

FDA approval of Zejula was based on data from the placebo-controlled Phase III ENGOT-OV16/NOVA study in 553 women with recurrent ovarian cancer who achieved either partial or complete remission on platinum-based chemotherapy. Maintenance therapy with Zejula reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations and by 55% in patients without germline BRCA mutations.

“Until recently, there have been few treatment advances for women with recurrent ovarian cancer and even fewer options available for women who do not harbor BRCA mutations,” stated Ursula Matulonis, M.D., director, gynecologic oncology at Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School. “We are excited to have the opportunity to offer appropriate patients an oral, once-daily maintenance treatment that reduces the risk of cancer progression and extends the time between courses of chemotherapy for patients who have few treatment options.”

Tesaro is currently developing niraparib both as monotherapy and as combination therapy against ovarian cancer. The Phase III PRIMA study is evaluating the drug in patients who have received first-line therapy, and the registrational Phase II QUADRA trial is ongoing to assess nariparib in patients who have received multiple treatments for ovarian cancer. Studies are also evaluating niraparib in combination with pembrolizumab and together with bevacizumab.

On announcing Zejula’s approval by the FDA,Tesaro confirmed that it would be expanding the nariparib development program to include front-line ovarian cancer therapy and metastatic ovarian, breast, and lung cancers. “With the approval of Zejula in hand, we will now begin to execute on our plans to pursue potentially transformational applications of niraparib in a broad range of metastatic cancer indications,” said Mary Lynne Hedley, Ph.D., Tesaro president and COO.

Prof. Hedley indicated that Tesaro plans to evaluate niraparib plus an anti-programmed cell death protein 1 (PD-1) antibody for maintenance therapy of ovarian cancer, and also assess niraparib–bevacizumab combination therapy in patients with a first recurrence  of ovarian cancer, a treatment the firm hopes could potentially replace chemotherapy for that setting.

“We remain strongly committed to studying niraparib in the breast cancer setting and also expect to initiate a new trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer,” Prof. Heldey added. “Finally, our goal to move niraparib into indications beyond ovarian and breast cancers encompasses plans to initiate a registration strategy for the first-line treatment of patients with metastatic non-small-cell lung cancer that includes a Phase II trial of niraparib in combination with an anti-PD-1 antibody in patients, regardless of programmed death-ligand 1 (PD-L1) tumor expression, and a Phase III trial of niraparib in combination with an anti-PD-1 antibody in patients with high levels of PD-L1 tumor expression.”   

Janssen Biotech negotiated global (ex-Japan) rights to develop niraparib for prostate cancer therapy  through a potentially $450 million deal signed with Tesaro just under a year ago. 


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