On February 4, 2020 Zai Lab Limited (NASDAQ: ZLAB), a China and U.S.-based innovative commercial stage biopharmaceutical company, reported that the first patients have been dosed in two separate clinical studies (Press release, Zai Laboratory, FEB 4, 2020, View Source [SID1234553834]):
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i)Phase 1b dose escalation and expansion clinical study of niraparib, in combination with MGD013, for the treatment of patients with advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (collectively as gastric cancer) who failed prior treatment, and
ii)Registrational bridging study of margetuximab, in combination with chemotherapy, for the treatment of patients with metastatic HER2-positive breast cancer, respectively.
Niraparib plus MGD013 Gastric Cancer Phase 1b Study
The Phase 1b clinical study is a single-arm, open-label, dose escalation and expansion study assessing the safety and antitumor activity of niraparib, an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with MGD013, a first-in-class, bispecific PD-1 x LAG-3 DART molecule, in patients with advanced or metastatic gastric cancer who failed prior treatment.
The primary endpoint of the study is assessing the safety of niraparib in combination with MGD013 in patients with advanced gastric cancer and determining the recommended phase 2 dose. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
Margetuximab plus Chemotherapy HER2-Positive Metastatic Breast Cancer Registrational Bridging Study
The registrational bridging trial is a randomized, open-label study evaluating the efficacy and safety of margetuximab, an Fc-engineered, monoclonal antibody that targets HER2, plus chemotherapy compared to trastuzumab plus chemotherapy in patients with metastatic HER2-positive breast cancer who have received prior anti-HER2 therapies.
The primary endpoint of the study is PFS. Secondary endpoints include OS, ORR, duration of response (DoR) and clinical benefit rate (CBR), as well as safety and pharmacokinetic profile of margetuximab in Chinese patients.
Zai Lab’s partner MacroGenics has submitted a Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy in December 2019. The submission is based on the safety and efficacy results of the pivotal Phase 3 SOPHIA study. Pending acceptance of the BLA, MacroGenics anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020.
About Gastric Cancer in China
Gastric cancer is the second most common cancer in China (679,100 newly diagnosed cases in 2015) and the second leading cause of death in China (498,000 deaths in 2015). The 5-year overall survival rate of gastric cancer is only 35.9%. Current therapies include surgery, chemotherapy, radiotherapy and targeted therapy. There is limited effective treatment option for patients with advanced or metastatic gastric cancer who have failed prior treatment in China and globally.
About Breast Cancer in China
Breast cancer is the most common cancer in Chinese women, with 272,400 newly diagnosed cases and 70,700 deaths in 2015. Approximately 25%~30% of all types of late stage breast cancer are HER2-positive. The 5-year overall survival rate of breast cancer is 83%. However, after treatment failure or disease progression after second-line anti-HER2 treatment, there is no approved effective treatment in last-line setting in China and globally.