On June 4, 2023 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, reported 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) (Free ASCO Whitepaper) Annual Meeting (ClinicalTrials.gov, NCT04085185) (Press release, Innovent Biologics, JUN 4, 2023, View Source [SID1234632432]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 (Free ASCO Whitepaper) 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.