Phase 3 NORA data of ZEJULA (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian ca - Seite 2

In September 2020, the China National Medical Products Administration (NMPA) has approved ZEJULA’s supplemental New Drug Application (sNDA) as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

About NORA Study

The NORA study was evaluated in 265 platinum-sensitive recurrent ovarian cancer patients randomized 2:1 to receive ZEJULA or placebo until disease progression. The study evaluated the efficacy of ZEJULA as a maintenance treatment, with the primary endpoint of PFS as assessed by blinded independent central review. The starting dose was individualized at 200 mg except for those with a baseline body weight ≥77kg and a platelet count ≥150K/μL in which case the starting dose was 300 mg.

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with approximately 52,000 newly diagnosed cases and 23,000 deaths in China. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA (Niraparib)

ZEJULA (niraparib) is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for the maintenance treatment of adult patients with advanced and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to first and second-line platinum-based chemotherapy.

Zai Lab has several studies ongoing or completed in Chinese patients with ovarian cancer:

• In November 2019, Zai Lab completed patient enrollment of its self-sponsored Phase III PRIME study evaluating ZEJULA as a first-line maintenance therapy in ovarian cancer patients who are in a complete or partial response to first-line platinum-based chemotherapy.
  
  
• In May 2020, Zai Lab announced positive top-line results from its self-sponsored Phase III NORA study of ZEJULA as maintenance therapy for Chinese patients with platinum-sensitive, recurrent ovarian cancer.
  
  
• In August 2020, the first patient was dosed in the registrational bridging trial for late-line ovarian cancer treatment.
  
  
• Zai Lab also conducted a Phase I pharmacokinetic (PK) study of ZEJULA in Chinese patients with ovarian cancer.