Innovent Presents Phase 1b Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2023 ASCO Annual Meeting
2023-06-05
临床1期免疫疗法临床结果ASCO会议上市批准
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 studyAbstract #: 2576
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[1]. 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[2]. 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 PD-1
and 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."Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb
PD-1
mAb) in advanced hepatocellular carcinoma (HCC)
: results from a Phase 1b studyAbstract #: 2577
IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody developed by Innovent Biologics. The Phase 1b study aims to evaluate the efficacy and safety of IBI110 in combination with sintilimab and lenvatinib as first-line therapy for
advanced HCC
.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[3]. 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
GC
and 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."About IBI110
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-1
/PD-L1
monoclonal antibody treatment[4]. Based on the urgent clinical needs, Innovent has carried out clinical studies to explore the efficacy and safety of IBI110 in various advanced tumors
.About Innovent
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
cancer
, autoimmune disease
, 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
cancer
, metabolic disorder
, 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.
Note:
TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.
Reference
[1] The Global
Cancer
Observatory - March, 2021. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf[2] China Guideline for the screening, early detection and early treatment of
gastric cancer
(2022, Beijing), Chin J Oncol, July 2022, Vol.44, No.7[3] 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.[4] J Thorac Oncol. 2017 May;12(5):814-823. 2. jco.2022.40.16_suppl.e2114
SOURCE: Innovent Biologics
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
适应症
胃癌,肝细胞癌,HER2阴性胃癌
[+8]
靶点
PD-1,LAG3,PDL1
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。