Zai Lab Reports Positive Results of PRIME Phase 3 Clinical Study of Zele® (Niraparib) at the American Society of Gynecologic Oncology (SGO) Annual Meeting

♦ The PRIME study demonstrated a statistically and clinically significant benefit of niraparib maintenance compared to placebo in improving progression-free survival (PFS) in the overall population ♦ PRIME The study met its primary endpoint with a median progression-free survival of 24.
8 months in the niraparib group, compared with 8.
3 months in the placebo group.
In the study population, niraparib maintenance therapy was tolerable, and Consistent with the safety profile in previous clinical studies, Zai Lab Co.
, Ltd.
recently reported details of the PRIME Phase 3 clinical study of Zele® (niraparib) as maintenance therapy at the American Society of Gynecologic Oncology (SGO) annual meeting.
data
.
Research confirms that Zele® is effective in newly diagnosed Chinese patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively referred to as ovarian cancer), regardless of biomarker status, following platinum-based chemotherapy Statistically and clinically significant improvement in progression-free survival (PFS) as maintenance therapy with a tolerable safety profile
.
In the PRIME study, patients receiving niraparib significantly prolonged median progression-free survival (PFS) compared with placebo, 24.
8 months versus 8.
3 months (PFS HR 0.
45; p < 0.
001)
.
Other prespecified efficacy outcomes included: In patients with gBRCA mutations, median PFS was not reached 10.
8 months versus placebo, HR, 95% CI: 0.
40 (0.
23, 0.
68); in patients without gBRCA mutations, median PFS 19.
3 month versus placebo 8.
3 months, HR, 95% CI: 0.
48 (0.
34, 0.
67) Although overall survival data are immature (mortality rates were 14.
5% and 21.
7% in the niraparib and placebo groups, respectively), However, at the data cutoff, the niraparib-treated group showed a trend toward superiority
.
A previous PRIMA study conducted by Zai Lab partner GlaxoSmithKline showed that maintenance niraparib following a response to first-line platinum-based chemotherapy was able to give advanced ovarian cancer compared with placebo regardless of biomarker status.
Cancer patients bring PFS benefits
.
In the PRIMA study, approximately 35% of patients received individualized niraparib treatment using an individualized starting dose (ISD) based on baseline body weight and platelet count
.
Except for patients with baseline body weight ≥77kg and platelet count ≥150K/μL, the starting dose was 300 mg, and the rest of the patients were treated with a starting dose of 200 mg
.
The current PRIME study aims to prospectively evaluate the efficacy and safety of ISD-based niraparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer who respond to first-line platinum-based chemotherapy, regardless of biomarker status and postoperative residual disease status
.
In the PRIME study, the safety profile of niraparib maintenance therapy improved with ISD being used prospectively in all patients
.
In prospective ISD-based maintenance therapy with niraparib, less than 7% of patients discontinued treatment due to adverse events, the lowest rate among all Phase 3 trials of PARP inhibitors for first-line maintenance therapy in ovarian cancer
.
Compared with the previous fixed starting dose, ISD reduced the incidence of hematological adverse events
.
Grade ≥3 hematologic adverse events, such as decreased neutrophil count, anemia, and decreased platelet count, occurred in 17.
3% vs 1.
6% and 18.
0% vs 1.
6% in the niraparib-treated and placebo groups, respectively.
% and 14.
1% vs.
0.
8%
.
Alan Sandler, president of Zai Lab and head of global development in oncology, said: "The data from the PRIME study further confirm that niraparib maintenance monotherapy has become the standard of care after first-line platinum-based chemotherapy in ovarian cancer, regardless of patient biomarker status.
how
.
Specifically, Zele® is the first and only PARP inhibitor approved in China and the world that can be used as a single agent for the first-line maintenance treatment of ovarian cancer in the entire population regardless of the patient's biomarker status
.
"I believe the data results of the PRIME study will have a significant impact on the clinical practice of first-line treatment of ovarian cancer in China and other regions, and its individualized starting dose The protocol demonstrated improved efficacy and safety
.
In addition, the PRIME study is the only study conducted in China to demonstrate that PARP inhibitor single-agent first-line maintenance therapy can significantly improve first-line maintenance therapy in newly diagnosed ovarian cancer patients in China, regardless of biomarker status and postoperative residual disease status.
Clinical studies of PFS
.
In September 2020, the National Medical Products Administration approved the supplemental New Drug Application for Zele® for the maintenance treatment of adult patients with advanced ovarian cancer after achieving a complete or partial response to first-line platinum-based chemotherapy
.
The Hong Kong Department of Health has also Zelex® (niraparib) was approved for the maintenance treatment of adult patients with advanced high-grade serous epithelial ovarian cancer after achieving a complete or partial response to first-line platinum-based chemotherapy
.
In December 2021, Zelex® (niraparib) was used for advanced The indications for first-line maintenance therapy (regardless of patient biomarker status) after remission of platinum-containing chemotherapy in adult patients with ovarian cancer have been included in the new version of the National Basic Medical Insurance Drug List (2021) issued by the National Medical Security Administration
.
The PRIME study is a randomized, controlled, double-blind, Phase 3 clinical study that evaluated 384 patients with advanced ovarian cancer who were randomly assigned in a 2:1 ratio to either a complete or partial response to first-line platinum-based chemotherapy.
The study evaluated the efficacy of Zele®
as maintenance therapy, and the primary endpoint was progression-free survival (PFS) assessed by an independent blinded center
.
Except for baseline body weight ≥77kg and Patients with platelet count ≥ 150K/μL were treated with a starting dose of 200 mg except for the starting dose of 300 mg.

.
About Ovarian Cancer Ovarian cancer is one of the most common gynecological tumors in China, with more than 55,000 new cases and 37,000 deaths annually in China [1]
.
Although ovarian cancer can be remission after initial platinum-based chemotherapy, most patients will inevitably face recurrence
.
Innovative drugs can prolong remission time after first-line platinum-containing chemotherapy, delay recurrence, and benefit Chinese ovarian cancer patients
.
[1] The 2020 edition of Global Cancer Statistics on Zelox® (niraparib) Zelox® (niraparib) is a once-daily oral poly(ADP-ribose) polymerase (PARP) inhibitor that The drug is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer after achieving a complete or partial response to first-line platinum-containing chemotherapy, and for platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Maintenance therapy for adult patients with primary peritoneal cancer after achieving a complete or partial response to platinum-based chemotherapy
.
In addition to the PRIME study, Zai Lab's completed studies in Chinese ovarian cancer patients include: In September 2020, Zai Lab announced the Phase 3 clinical study of NORA in the maintenance treatment of ZEJULA® in Chinese patients with platinum-sensitive recurrent ovarian cancer.
The results of the study confirmed a significant PFS benefit and improved safety with ZEJURA maintenance treatment regardless of biomarker status
.
Zele® has conducted a Phase 1 pharmacokinetic study in Chinese ovarian cancer patients
.
Zai Lab has entered into a cooperation and licensing agreement with GlaxoSmithKline to be responsible for the development and commercialization of Zele® (independently manufactured by Zai Lab) in mainland China, Hong Kong, and Macau
.
About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, patient-centric, commercial-stage global biopharmaceutical Development and commercialization of therapeutics to address unmet medical needs in oncology, autoimmunity, infectious diseases and the central nervous system
.