ZEJULA Phase 3 NORA Study: Final OS Results in Platinum-Sensitive Recurrent Ovarian Cancer

Zai Lab Limited, a biopharmaceutical company with a presence in both China and the United States, has reported final overall survival data from a Phase 3 study on ZEJULA® (niraparib). The study, known as NORA, involved Chinese patients suffering from platinum-sensitive recurrent ovarian cancer (PSROC). The data indicates that ZEJULA, a PARP inhibitor, has shown promising results when used as a maintenance therapy with a personalized starting dose.

The NORA study involved 265 participants who were randomly assigned to receive either niraparib or a placebo. The final overall survival analysis was completed after more than half of the expected events occurred within the study's patient group. The findings suggest that ZEJULA, when administered based on the patient's weight and platelet count, demonstrated a favorable trend in overall survival compared to the placebo group. Importantly, the study did not identify any new safety concerns during the extended follow-up period.

ZEJULA is an oral medication that inhibits PARP 1/2, enzymes that cancer cells rely on to repair DNA damage caused by radiation and certain chemotherapy treatments. By blocking these enzymes, ZEJULA can lead to the death of cancer cells that are unable to repair themselves. Tumors deficient in key DNA repair pathways, such as those with BRCA1 mutations, are particularly sensitive to ZEJULA's effects.

Ovarian cancer remains a significant health concern in China, with over 55,000 new cases and 37,000 deaths reported annually. While platinum-based chemotherapy can induce an initial response, the disease often recurs. The introduction of new agents like ZEJULA that can extend the duration of response and delay relapse is seen as beneficial for patients in China.

Zai Lab's exclusive license from GSK allows them to develop and commercialize ZEJULA in mainland China, Hong Kong, and Macau. The company is dedicated to addressing unmet medical needs in various therapeutic areas, including oncology, autoimmune disorders, infectious diseases, and neuroscience.

The final overall survival data from the NORA study is expected to be presented at two upcoming conferences: the 2024 Congress of the European Society of Gynaecological Oncology (ESGO) in Barcelona, Spain, and the 2024 Society for Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer in San Diego, California. These presentations will provide further insights into the effectiveness and safety profile of ZEJULA in the treatment of PSROC.

Zai Lab is an innovative company committed to discovering, developing, and commercializing products that have a significant impact on human health.