JAMA Oncology has just published data from the Zai Lab‘s Phase 3 PRIME study, highlighting the positive outcomes of ZEJULA (niraparib) as a first-line maintenance therapy for Chinese patients with advanced ovarian cancer. The study reveals that ZEJULA significantly prolongs progression-free survival and reduces the risk of disease progression or death by 55%. These findings offer hope for improved outcomes in a broad range of patients with ovarian cancer.
The PRIME study, a Phase 3 clinical trial conducted at 29 hospitals in mainland China, involved 384 patients who had received platinum-based chemotherapy. The results showed that ZEJULA monotherapy improved progression-free survival compared to placebo, with a median progression-free survival of 24.8 months versus 8.3 months in the placebo group. The study also demonstrated a tolerable safety profile for ZEJULA as a maintenance therapy.
ZEJULA’s benefits were consistent across various patient subgroups, including those with the gBRCA mutation and different levels of postoperative residual disease. Additionally, individualized dosing based on bodyweight and platelet count showed significant benefits and improved safety compared to fixed dosing.
“Women with advanced ovarian cancer have a poor prognosis, with a global 5-year survival rate of less than 50 percent and a recurrence rate of approximately 75 percent,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “The positive results from the PRIME study, which show a substantial reduction in risk of disease progression or death with ZEJULA maintenance, offer insights into the potential to delay the progression of this devastating disease in a broad group of patients. We look forward to continuing to work with our partners to improve outcomes for women living with ovarian cancer.”
Ovarian cancer is a challenging disease with a low survival rate and high recurrence rate. The positive results from the PRIME study provide hope for delaying disease progression and improving outcomes in a broad range of ovarian cancer patients.
ZEJULA, an oral PARP inhibitor, is approved for maintenance treatment in advanced and platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. Zai Lab holds the license for ZEJULA’s development and commercialization in mainland China, Hong Kong, and Macau.
The publication of these study results contributes to ongoing efforts in the fight against ovarian cancer and brings hope to patients and healthcare providers seeking effective treatment options.