Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced with Eli Lilly and Company that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for TYVYT® (sintilimab injection) as second-line therapy for squamous non-small cell lung cancer (sqNSCLC). The application is the third sNDA for TYVYT® (sintilimab injection) in NSCLC.
This sNDA was based on a randomized, open-label, Phase 3 clinical trial (ORIENT-3)—evaluating TYVYT® (sintilimab injection) as second-line therapy for patients with advanced or recurrent sqNSCLC whose cancer had progressed on first-line platinum-based chemotherapy. Based on the final analysis in the pre-specified full analysis set, TYVYT® demonstrated a statistically significant improvement in overall survival (OS) compared with docetaxel, which met the pre-specified superiority criteria. The progression-free survival (PFS) and objective response rate (ORR) were also significantly improved. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference or journal.
The principal investigator of ORIENT-3, Professor Yuankai Shi, Associate Dean of Cancer Hospital, Chinese Academy of Medical Sciences, stated: "Lung cancer is the leading cause of cancer death globally, of which NSCLC accounts for 80% to 85%. In the past few decades, drug development of NSCLC has mainly focused on nonsquamous NSCLC, while drug development of squamous NSCLC has been slower due to its unique epidemiological, histopathological and molecular characteristics. In China, the options for second-line immunotherapy are even more limited. The ORIENT-3 study confirmed that the anti-PD-1 monoclonal antibody sintilimab significantly improved OS for the second-line treatment of squamous NSCLC patients, which is of great clinical value. We hope that the positive results of ORIENT-3 can potentially help more squamous NSCLC patients."
"TYVYT® (sintilimab injection) is the first anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List," said Dr. Hui Zhou, Vice President of Medical Science and Strategy Oncology of Innovent. "In August 2020, the NMPA accepted a new indication application for TYVYT® (sintilimab injection) in combination with chemotherapy for first-line treatment of squamous NSCLC. In ORIENT-3 study, sintilimab as second-line monotherapy demonstrated a significantly improved survival benefit for patients with advanced squamous NSCLC, and we look forward to the approval of this indication, to potentially help more patients with this type of lung cancer."
"We are excited about these results, showing TYVYT® (sintilimab injection) significantly improved overall survival in this patient population. This study underscores the joint commitment from Lilly and Innovent to provide innovative treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, the investigators, the clinical trial centers and our colleagues from Innovent that are involved in the study. We look forward to working together to potentially bring this new treatment option to patients in China with squamous NSCLC."
About ORIENT-3 Trial
ORIENT-3 is a randomized, open-label, multi-center, Phase 3 clinical trial in China to evaluate the efficacy and safety of TYVYT® (sintilimab injection) as second-line therapy for advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT 03150875). The primary endpoint is overall survival (OS). The secondary endpoints include progression-free survival (PFS) assessed by investigators based on RECIST v1.1, objective response rate (ORR) and safety profile.
A total of 290 patients were enrolled in ORIENT-3 and randomized in a 1:1 ratio to receive either TYVYT® (sintilimab inject...
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