ROCKVILLE, MD, USA and SUZHOU, China I June 4, 2023 I Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announced that Phase 1b clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in the first-line treatment of
gastric cancer and first-line treatment of
hepatocellular carcinoma are presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (ClinicalTrials.gov, NCT04085185).
Efficacy and safety of IBI110 in combination with sintilimab in first-line
advanced HER2-negative gastric cancer or
gastroesophageal junction cancer: results from a Phase 1b study
In this Phase 1b study, the efficacy and safety of IBI110 in combination with sintilimab and chemotherapy as first-line therapy for
advanced GC was evaluated.
Professor Nong Xu, The First Affiliated Hospital, School of Medicine, Zhejiang University, stated: "
Gastric cancer is the second most common malignancy in China. Most patients with
GC are already locally advanced or metastatic when they were first diagnosed, and the 5-year survival rate is relatively low for those patients. In recent years, immunotherapy has shown certain efficacy in
advanced gastric cancer, but there is still room for improvement in clinical practice. In 2022, FDA and EMA approved the dual blocking therapy of
LAG-3 for advanced melanoma, but no studies have reported clinical benefits of the combined therapy in patients with
gastric cancer. In this study, based on the current standard treatment of sintilimab and chemotherapy, combination with IBI110 showed robust antitumor activity in untreated
gastric cancer patients, and clinical benefits were observed both in
tumor shrinkage and PFS, with manageable safety profile, which gave us more confidence to carry out follow-up studies."
Professor Baocai Xing, Peking University
Cancer Hospital & Institute, stated: "Immune-checkpoint inhibitors combined with anti-angiogenic agents has been approved as the first-line treatment for
advanced HCC, but many patients develop disease progression within half a year of treatment, where exists an unmet clinical need. In this study, IBI110 combined with sintilimab and lenvatinib showed robust antitumor activity in untreated
advanced HCC patients, with a median PFS of 9.9 months, and no new safety signals were observed. This study is also the first clinical trial reporting preliminary efficacy and safety data of
LAG-3 targeting therapy in first line treatment of patients with
advanced HCC, suggesting the potential of further exploration in this indication."
Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ASCO Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in the first-line treatment of
HCC. We will continue to provide updates on the clinical data for IBI110. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, which we hope will benefit patients in need soon."
IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics. Based on the mechanism of action and preclinical data of IBI110, it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-
tumor effect, which may further improve the efficacy of immunotherapy, overcome the primary drug resistance, and overcome the drug resistance after anti-
PD-L1 monoclonal antibody treatment. Based on the urgent clinical needs, Innovent has carried out clinical studies to explore the efficacy and safety of IBI110 in various
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture 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
metabolic disorder 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 35 valuable assets in the fields of
autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA®(bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA®(rituximab biosimilar injection), Pemazyre®(pemigatinib oral inhibitor), olverembatinib (BCR ABL TKI), Cyramza® (ramucirumab) and Retsevmo®(selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase 3 or pivotal clinical trials, and 18 more molecules are in clinical studies.
Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center
Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.
Disclaimer: Innovent does not recommend any off-label usage. TYVYT® (sintilimab injection) is not an approved product in the United States.  The Global
Cancer Observatory - March, 2021. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
 China Guideline for the screening, early detection and early treatment of
gastric cancer (2022, Beijing), Chin J Oncol, July 2022, Vol.44, No.7
 Finn R S, Qin S, Ikeda M, et al. Atezolizumab plus Bevacizumab in
Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905.
 J Thorac Oncol. 2017 May;12(5):814-823. 2. jco.2022.40.16_suppl.e2114