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, and Eli Lilly and Company, today jointly announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) of TYVYT® (sintilimab injection) in combination with pemetrexed and platinum chemotherapy as first-line therapy for people with nonsquamous non-small cell lung cancer (nsqNSCLC). This is the second approved indication of TYVYT® (sintilimab injection) in China, following the first approved indication by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy.
The approval was based on a randomized, double-blind, Phase 3 clinical trial (ORIENT-11), which evaluated TYVYT® (sintilimab injection) or placebo in combination with ALIMTA® (pemetrexed injection) and platinum chemotherapy as first-line therapy for people with advanced or recurrent nsqNSCLC without sensitizing EGFR mutations or ALK rearrangements. A total of 397 participants were enrolled and were randomized in a 2:1 ratio (266 participants in the sintilimab combination arm, 131 participants in the placebo combination arm). ORIENT-11 demonstrated a statistically significant improvement in progression-free survival (PFS) of TYVYT® (sintilimab injection) in combination with ALIMTA® and platinum chemotherapy compared with placebo in combination with ALIMTA® and platinum chemotherapy. The median PFS of sintilimab combination arm and placebo combination arm assessed by Independent Radiographic Review Committee was 8.9 months and 5.0 months respectively, HR (95%CI) = 0.482 (0.362,0.643), P < 0.00001. Overall survival (OS) was not mature at interim analysis. The safety profile is consistent with previously reported TYVYT® (sintilimab injection) studies, and no new safety signals were identified.
At updated analysis after extended follow up, median OS of sintilimab combination arm was still not reached, while median OS of placebo combination arm was 16.0 months. Sintilimab combination significantly improved overall survival, HR (95%CI) = 0.606 (0.437,0.841), P=0.00250[1]. Details of the updated OS result will be published in near future.
Professor Li Zhang, head of the department of Oncology from Sun Yat-sen University Cancer Center, stated: "In China, about 60 percent of NSCLC cases are nonsquamous NSCLC, of which nearly 50 percent patients are gene-driven negative. There are large unmet medical needs for such patients with advanced lung cancer where targeted therapy is not suitable and treatment options are limited. In recent years, research on activating the human body's immune system by suppressing immune checkpoints to make it play a role in attacking tumor cells have progressed rapidly. Using immune checkpoint inhibitors (such as anti-PD-1/PD-L1 antibodies) have provided new clinical approaches in the first-line treatment of recurrent or metastatic advanced NSCLC. We hope the new indication approval of TYVYT® (sintilimab injection) can benefit more patients."
Dr. Yongjun Liu, President of Innovent, stated: "The efficacy and safety profile of TYVYT® (sintilimab injection) as a high-quality PD-1 inhibitor is further proven in the ORIENT-11 trial. We are excited about the approval of TYVYT® in this new indication which marks a milestone for TYVYT® (sintilimab injection) in the treatment of NSCLC. We look forward to bringing this treatment option to nonsquamous non-small cell lung cancer patients."
Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "In China, lung cancer has the highest incidence and mortality rate among all tumor types. Although treatment technology is advancing, there is still a large number of lung cancer patients lack of effective treatments. The new indication of TYVYT® (sintilimab injection) has provided more treatment option for patients with first-line nonsquamous NSCLC. We sincerely hope that TYVYT® (sintilimab injection) will help more patients with advanced lung cancer and their famili...
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