Innovent Presents Phase 1b Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2023 ASCO Annual Meeting

ROCKVILLE, Md. and SUZHOU, China, June 5, 2023 /PRNewswire/ -- 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

Abstract #: 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.

• 17 untreated advanced GC patients received 200 mg IBI110 combined with sintilimab and chemotherapy (XELOX). As of the data cutoff date (Mar 22, 2023), median follow-up time was 15.8 (95% CI, 13.4 -16.6) months, 15 patients achieved PR, the ORR was 88.2%; the median DoR was 10.6 (95% CI, 2.5-14.4) months; the median PFS was 12.9 (95% CI, 3.8-15.8) months; the median OS was not mature yet.
• As for safety, treatment related adverse events (TRAEs) ≥ grade 3 occurred in 11 patients, the most common TRAEs ≥ grade 3 were platelet count decreased (23.5%) and neutrophil count decreased (17.6%). 3 patients experienced irAE≥ grade 3. There were no treatment-related deaths.

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) in advanced hepatocellular carcinoma (HCC): results from a Phase 1b study

Abstract #: 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.

• 28 treatment-naïve advanced HCC patients received IBI110 (200 mg, Q3W) combined with sintilimab and lenvatinib and 27 of them received at least 1 post-baseline tumor assessment. As of the data cutoff date (Mar 22, 2023), median follow-up time was 12.2 (95% CI, 11.0 -12.6) months, the objective response rate (ORR) and disease control rate (DCR) was 29.6% and 85.2%, respectively; the median progression free survival (PFS) was 9.9 (95% CI, 5.7-NC) months; the PFS data was still immature and follow-up will be continued; the median overall survival (OS) was not reached.
• In terms of safety, 16 patients experienced ≥ grade 3 TRAEs, the most common ≥ grade 3 TRAEs were hypertension (25%) and platelet count decreased (7.1%).

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 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)

HALPRYZA® (rituximab 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.

CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo®(selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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}