On October 5, 2020 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported dosing of the first patient in China in the global Phase 3 POD1UM-304 study evaluating retifanlimab, an investigational anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with first-line metastatic non-small-cell lung cancer (NSCLC) (Press release, Zai Laboratory, OCT 5, 2020, View Source [SID1234568280]).
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"Non-small cell lung cancer is the most common tumor type and represents a significant unmet medical need in China," said Dr. Samantha Du, Founder, Chairwoman and Chief Executive Officer of Zai Lab. "Anti-PD-1 therapies are the backbone to many current and future immuno-oncology therapy combinations and we are excited to contribute patients to the POD1UM-304 Phase 3 registrational study and join Incyte in its endeavor to bring this potential new therapy to patients globally."
POD1UM-304 is a Phase 3, randomized, multicenter, double-blind study evaluating retifanlimab in combination with platinum-based chemotherapy in patients with first-line metastatic squamous and non-squamous non-small cell lung cancer. The study is expected to enroll approximately 530 adult patients randomized to receive retifanlimab or placebo in combination with standard therapy of platinum-based chemotherapy. Zai Lab and its partner, Incyte, will cooperate in conducting the study in Greater China with Zai Lab taking the operational lead by conducting the screening, enrollment and treatment of patients in Greater China. The primary endpoints of the study are overall survival (OS) and progression-free survival (PFS) as determined by blinded independent central review using RECIST v1.1. Key secondary endpoints include objective response rate (ORR), duration of response (DOR), safety and pharmacokinetics.
About NSCLC
Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 774,000 new cases and 690,500 deaths of lung cancer in China in 2018, respectively. NSCLC accounts for approximately 85 percent of lung cancer, and approximately 70 percent of NSCLC is locally advanced or metastatic at initial diagnosis.
About Retifanlimab (INCMGA0012)
Retifanlimab (formerly INCMGA0012), an investigational anti-PD-1 antibody, is currently under evaluation in registration-directed studies as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.
Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.
In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.