China clears sNDA for combination therapy of NSCLC
10 May 2023
ImmunotherapyDrug ApprovalPhase 3Clinical ResultBiosimilar
Sintilimab is marketed as TYVYT (sintilimab injection) in China. Credit: Mufid Majnun on Unsplash.
Innovent Biologics and Eli Lilly and Company have announced approval by the National Medical Products Administration (NMPA) of China for the supplemental New Drug Application (sNDA) for a combination therapy to treat patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor (TKI) therapy.
The approval was given to TYVYT (sintilimab injection) plus bevacizumab and chemotherapy (pemetrexed and cisplatin).
This is the seventh indication of TYVYT (sintilimab injection) to be cleared by NMPA.
TYVYT is a PD-1 immunoglobulin G4 monoclonal antibody jointly developed by Innovent Biologics and Eli Lilly and Company.
The regulatory clearance is based on data from the ORIENT-31 Phase III randomised, double-blind, multi-centre trial that assessed TYVYT (sintilimab injection) greater or less than BYVASDA (bevacizumab injection) and chemotherapy (pemetrexed and cisplatin).
The trial’s second interim evaluation showed that significant and clinically meaningful progression-free survival (PFS) was continued with sintilimab plus bevacizumab plus chemotherapy, in comparison with chemotherapy alone, in the intent-to-treat group.
The assessment was made by the independent radiographic review committee.
Major secondary endpoints of objective response rate and duration of response were also found to be improved when patients were treated with sintilimab plus bevacizumab plus chemotherapy, in comparison with chemotherapy alone.
Up to the data cut-off date of 4 July 2022, an overall survival (OS) trend with sintilimab plus bevacizumab and chemotherapy was seen, even though the median OS for chemotherapy was extended because of crossover following progression in the chemotherapy group.
Innovent Biologics founder, chairman and CEO Dr Michael Yu stated: “Despite proven efficacy in broad types of cancer, immunotherapy has rarely made breakthroughs in the treatment of driver gene-positive non-squamous NSCLC patients.
“We are excited about the results of the ORIENT-31 study, and this new approval marks the first immunotherapy combination therapy approved for patients with driver gene-positive non-squamous NSCLC in China, making TYVYT the first PD-1 inhibitorPD-1 inhibitor approved for driver gene-positive non-squamous NSCLC globally.”
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