Innovent and Lilly Jointly Announce Results of Seven Clinical Studies of TYVYT® (sintilimab injection) to Be Presented at the ESMO ASIA Congress 2020
SAN FRANCISCO and SUZHOU, China, Nov. 5, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly", NYSE: LLY) jointly announce that results of seven clinical studies of TYVYT® (sintilimab injection) will be presented during the upcoming European Society of Medical Oncology ASIA ("ESMO ASIA") Virtual Congress 2020 from November 20th to 22nd.
The seven studies of TYVYT® (sintilimab injection) to be presented on ESMO ASIA include one Proffered Paper Oral Presentation (a Phase 3 study) and six e-posters, covering indications including lung cancer, liver cancer, gastric cancer, and esophageal cancer.
Cancer Type：Liver cancer
Presentation Type：Proffered Paper Oral Presentation
Title: Sintilimab plus bevacizumab biosimilar vs. sorafenib as first-line treatment for advanced hepatocellular carcinoma (ORIENT-32)
Presenter：Professor Zhenggang Ren
Date of Presentation: 21 November 2020
Cancer Type：Liver cancer
Title：Sintilimab plus anlotinib as first-line therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC)
Leading PI：Professor Xiaofeng Chen
Cancer Type：Non–Small Cell Lung Cancer
Title： Efficacy and Safety of Sintilimab Plus Docetaxel in Patients with Previously Treated Advanced Non–Small Cell Lung Cancer
Leading PI：Professor Zhehai Wang
Cancer Type：Non–Small Cell Lung Cancer
Title：A Single-Arm Phase Ib Study of Autologous Cytokine-Induced Killer (CIK) Cell Immunotherapy in Combination with Sintilimab plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer
Leading PI：Professor Xiubao Ren
Cancer Type：Esophageal cancer
Title：A study of neoadjuvant sintilimab combined with triplet chemotherapy of lipo-paclitaxel, cisplatin, and S-1 for resectable esophageal squamous cell carcinoma（ESCC）
Leading PI：Professor Yanhong Gu
Cancer Type：Gastric cancer
Title：Phase II study of sintilimab combined with FLOT regimen for neoadjuvant treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma
Leading PI： Professor Suxia Luo, Ning Li
Cancer Type：Gastric cancer
Title: Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma
Leading PI： Professor Baorui Liu
About TYVYT® (Sintilimab Injection)
TYVYT® (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT® (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT® (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT® (sintilimab injection) in combination with GEMZAR® (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT® (sintilimab injection) in combination with BYVASDA® (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.
TYVYT® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT® (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT® (sintilimab injection) worldwide.
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with four products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.
Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Roche, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: www.innoventbio.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to create medicines to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and lilly.com/newsroom.
About Innovent's strategic collaboration with Eli Lilly and Company
Innovent entered into a strategic collaboration with Lilly focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Innovent and Lilly are co-developing and commercializing oncology medicines, including TYVYT® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization. In August, 2020，Lilly and Innovent announced a global expansion of their strategic alliance for TYVYT® (sintilimab injection), and Lilly will obtain an exclusive license for TYVYT® (sintilimab injection) for geographies outside of China and plans to pursue registration of TYVYT® (sintilimab injection) in the U.S. and other markets.
TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection) is not an approved product in the United States.
SULINNO® (adalimumab biosimilar injection) is not an approved product in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
ALIMTA® and GEMZAR® are trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.
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