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    Home > Medical News > Medical Research Articles > Innovent and Eli Lilly will jointly announce final clinical results and biomarker analysis of the Phase Ib study of Dabosu (sintilimab injection) combined with bevacizumab in the treatment of advanced hepatocellular carcinoma at ASCO GI in 2022 result

    Innovent and Eli Lilly will jointly announce final clinical results and biomarker analysis of the Phase Ib study of Dabosu (sintilimab injection) combined with bevacizumab in the treatment of advanced hepatocellular carcinoma at ASCO GI in 2022 result

    • Last Update: 2022-02-18
    • Source: Internet
    • Author: User
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    SAN FRANCISCO, USA and SUZHOU, China, Jan.
    22, 2022 /PRNewswire/ --
    Innovent Biopharmaceutical Group (SEHK: 01801), a research and development, The biopharmaceutical company and Eli Lilly (NYSE: LLY), a biopharmaceutical company with innovative medicines for major diseases such as autoimmunity, jointly announced that Dabosu® ( sintilimab injection) combined with bevacizumab in the treatment of advanced liver disease Final clinical study results and biomarker analysis for cell carcinoma Phase Ib (NCT04072679), presented in abstract form (Accession #455) at the 2022 American Society of Clinical Oncology Symposium on Gastrointestinal Oncology (ASCO GI)
    .

    The study is a Phase Ib trial (NCT04072679) evaluating the safety, tolerability and antitumor activity in Chinese patients with locally advanced/metastatic hepatocellular carcinoma who have not or failed systemic therapy.
    Two parts, the first part is a dose escalation study and the second part is a dose expansion study

    .
    During the dose escalation phase, subjects will receive 7.
    5 mg/kg (low dose group) or 15 mg/kg (high dose group) of bevacizumab according to the order of enrollment, in combination with a fixed dose of 200 mg of Dabosu
    ® treatment, enter the dose expansion phase after completing the dose escalation study
    .
    A total of 50 subjects were enrolled in the study, including 29 subjects in the low-dose group and 21 subjects in the high-dose group, respectively

    .
    The safety profile of the combined treatment regimen was consistent with the results of previously reported clinical studies, and there were no new safety signals

    .
    The most common treatment-related adverse events (TRAEs) included hypertension (32%), proteinuria (26%), and pyrexia (26%)

    .
    The incidence of grade ≥3 adverse events in the low-dose and high-dose groups was 13.
    8% and 28.
    6%, respectively

    .

    In terms of efficacy, the overall objective response rate (ORR) was 34% (17/50), with ORRs of 31% and 38% in the low-dose and high-dose groups, respectively
    .
    The overall disease control rate (DCR) was 78% (39/50)

    .
    The median progression-free survival (PFS) was 10.
    5 months (95%CI, 8.
    4-12.
    7), and the median overall survival (OS) was 20.
    2 months (95%CI, 16.
    1-24.
    3)

    .
    Further biomarker analysis showed that subjects with CD137 serum concentrations ≥31.
    8 pg/mL had longer PFS (mPFS: 14.
    2 vs.
    4.
    1 months, p=0.
    001) and OS (mOS: not reached vs.
    15.
    6 month, p=0.
    023)

    .
    Tumor immune microenvironment analysis (TiME) showed that a high density of interstitial M1 macrophages (CD68+, CD163-) was significantly associated with better efficacy, longer PFS and OS

    .

    Professor Zhou Aiping from Cancer Hospital, Chinese Academy of Medical Sciences said : "This study not only provides safety and efficacy data for sintilimab combined with different doses of bevacizumab, but also discovers a biological predictor of the efficacy of the combination regimen in the treatment of hepatocellular carcinoma.
    The markers provide a certain basis for the selection of precise treatment populations in clinical guidance medication

    .

    Dr.
    Hui Zhou, Senior Vice President of Innovent Biopharmaceutical Group, said
    : "Sintilimab combined with bevacizumab for first-line treatment of advanced hepatocellular carcinoma was approved in China in June last year and successfully included in the national medical insurance
    .
    This study Provided data on the combined use of two different doses of bevacizumab and sintilimab, and explored the predictors of the efficacy of liver cancer immunotherapy, providing clinicians with more and better choices to promote tumor immunotherapy Further progress towards precision and individualization

    .

    Lilly Wang, Senior Vice President of China and Head of Drug Development and Medical Affairs Center, said: "The collaboration between Eli Lilly and Innovent is committed to bringing anti-tumor drugs of international quality to Chinese cancer patients
    .
    The release of phase Ib study data of limumab injection) combined with bevacizumab in the treatment of advanced hepatocellular carcinoma provides a more solid basis for individualized and precise treatment for clinical treatment, and improves the overall cancer 5-year survival rate by 15% in 2030 We look forward to continuing in-depth cooperation with Innovent to bring good news to more patients in the future .


    About the NCT04072679 study

    NCT04072679 is a Phase Ib study evaluating the safety, tolerability and antitumor activity of Dabosu® in combination with bevacizumab in subjects with advanced hepatocellular carcinoma
    .
    The study is divided into two parts, the first part is a dose escalation study and the second part is a dose expansion study

    .
    During the dose escalation phase, subjects will receive 7.
    5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of bevacizumab according to the order of enrollment, in combination with a fixed dose of Dabosu® 200mg treatment, after completing the dose escalation study, enter the dose expansion phase

    .

    About liver cancer

    Liver cancer is a common malignant tumor of the digestive system in the world.
    China accounts for about half of the world's liver cancer patients.
    Liver cancer seriously threatens the life and health of our people

    .
    The main pathological type of liver cancer is hepatocellular carcinoma (HCC), accounting for 85% to 90%; a few are intrahepatic cholangiocarcinoma (ICC) and HCC-ICC mixed type

    .
    In China, HCC is mainly caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection

    .

    About sintilimab

    Sintilimab, with Chinese trade name Daboshu® ( sintilimab injection), is an innovative PD-1 inhibitor drug with international quality jointly developed by Innovent Biopharmaceuticals and Eli Lilly
    .
    Sintilimab is a human immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking PD-1/programmed death receptors that lead to tumor immune tolerance.
    The Programmed Death-Ligand 1 (PD-L1) pathway reactivates the anti-tumor activity of lymphocytes, thereby achieving the goal of treating tumors

    .
    More than two dozen clinical studies (of which more than 10 are registration clinical trials) are currently underway to evaluate the antitumor effect of sintilimab on various solid tumors and hematological tumors

    .

    Sintilimab has been approved in China for four indications and has been successfully included in China's National Medical Insurance List, including:

    • For the treatment of relapsed or refractory classical Hodgkin lymphoma that has undergone at least second-line systemic chemotherapy;
    • Combination of pemetrexed and platinum-based chemotherapy for first-line treatment of EGFR- or ALK-negative advanced non-squamous NSCLC;
    • Combined with gemcitabine and platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic squamous NSCLC;
    • Combined with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy
      .

    In addition, the marketing applications of sintilimab for three indications have been accepted and reviewed by the China National Medical Products Administration (NMPA), including:

    • Combination of cisplatin and paclitaxel/cisplatin and 5-fluorouracil for first-line treatment of advanced or metastatic esophageal squamous cell carcinoma;
    • Combination of oxaliplatin and capecitabine in the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric and gastroesophageal junction adenocarcinoma;
    • Combination of bevacizumab and chemotherapy for epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)-failed EGFR-mutant non-squamous non-small cell lung cancer
      .

    Two additional clinical trials of sintilimab met study endpoints, including:

    • Phase II clinical study of single drug for second-line treatment of advanced/metastatic esophageal squamous cell carcinoma;
    • Phase III clinical study of single agent for second-line treatment of advanced squamous non-small cell lung cancer failed platinum-containing chemotherapy
      .

    In May 2021, the marketing application of sintilimab combined with pemetrexed and platinum for the first-line treatment of non-squamous NSCLC has been officially accepted and reviewed by the US FDA
    .

    About Dayoton® ( bevacizumab)

    Dayutong® is a biosimilar drug of bevacizumab injection, also known as recombinant anti-VEGF humanized monoclonal antibody injection
    .
    VEGF is an important factor in the process of angiogenesis and is pathologically overexpressed in most human tumor endothelial cells

    .
    Anti-VEGF antibody can selectively bind VEGF with high affinity, and block the transduction of signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK by blocking the binding of VEGF to its receptors on the surface of vascular endothelial cells.
    It can inhibit the growth, proliferation, migration and angiogenesis of vascular endothelial cells, reduce vascular permeability, block the blood supply of tumor tissue, inhibit the proliferation and metastasis of tumor cells, and induce tumor cell apoptosis, thereby achieving anti-tumor therapeutic effects

    .
    Since its launch, the original research drug bevacizumab injection has been approved globally for the treatment of non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer, fallopian tube cancer Cancer, peritoneal cancer and many other solid tumors, its remarkable curative effect and good safety have been generally recognized

    .
    In China, Dayuton® has been approved for the
    treatment of advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma and hepatocellular carcinoma
    .

    About Innovent

    "Begins with faith, achieves in action", and developing high-quality biological drugs affordable to the common people is the ideal and goal of Innovent
    .
    Founded in 2011, Innovent Bio is committed to the development, production and sales of innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, and autoimmunity

    .
    On October 31, 2018, Innovent Biopharma was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801

    .

    Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
    .
    A product chain including 26 new drug varieties has been established, covering tumor, metabolic diseases, autoimmunity and other disease fields, of which 7 varieties have been selected for the national "Major New Drug Creation" project

    .
    The company has 6 products (Sintilimab injection, trade name: Daboshu® , English trademark: TYVYT ®
    ; Bevacizumab biosimilar, trade name: Dayutong® , English trademark: BYVASDA ® ; Adalimumab biosimilars, trade name: Su Lixin® , English trademark: SULINNO® ; Rituximab biosimilars, trade name: Dabohua® , English trademark: HALPRYZA® ; pemigatinib oral inhibitor , trade name: Darbotan® , English trademark: PEMAZYRE ® ; Orebatinib Tablets, trade name: Nerlik® ) was approved for marketing, and the listing application of sintilimab in the United States was accepted by the FDA, and 5 The varieties have entered Phase III or pivotal clinical research, and another 15 products have entered clinical research .

    Innovent Bio has established a high-end biopharmaceutical development and industrialization talent team with international advanced level, including many returnee experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi in South Korea.
    reach a strategic cooperation

    .
    Innovent Biotechnology hopes to work together with everyone to improve the development level of China's biopharmaceutical industry to meet the availability of medicines and the pursuit of people's good wishes for life and health

    .
    For more information, please visit the company's website:
    or the company's LinkedIn account at .

    About Eli Lilly

    Eli Lilly is a leading global pharmaceutical company dedicated to improving human health through innovation
    .
    Eli Lilly was born more than a century ago, with founders dedicated to producing high-quality medicines to meet real medical needs

    .
    Today, we remain committed to this mission and work based on it

    .
    Across the globe, our employees work hard to develop life-changing medicines and bring them to those patients who really need them

    .
    Not only that, but we are also committed to improving public understanding and management of disease, while giving back to society through our philanthropy and volunteer activities

    .
    For more information about Lilly, please visit:
    .

    About the strategic cooperation between Eli Lilly and Innovent

    Eli Lilly and Innovent reached a biotech drug development cooperation in March 2015, which is also one of the largest cooperation between a Chinese biopharmaceutical company and a multinational pharmaceutical company to date
    .
    Under the terms of the partnership, Eli Lilly and Innovent will co-develop and commercialize oncology drugs including Dabosu® (
    sintilimab injection) in China
    .
    In October 2015, the two parties announced that they would once again expand their established drug development collaboration, adding three novel oncology therapeutic antibodies

    .
    In August 2019, the collaboration between the two parties was extended to the field of diabetes, and Innovent was authorized to develop and commercialize a potentially best-in-class new clinical-stage diabetes drug from Eli Lilly in China

    .
    These three collaborations with Eli Lilly signify that Innovent Bio has established a comprehensive strategic partnership between Chinese innovative pharmaceutical companies and global pharmaceutical giants, covering new drug research and development, clinical research, production quality and market sales

    .

    Disclaimer:
    For communication use by healthcare professionals only
    .

    Innovent Forward-Looking Statements

    Information published in this press release may contain certain forward-looking statements
    .
    These statements are inherently subject to considerable risk and uncertainty

    .
    The use of words such as "anticipates," "believes," "forecasts," "expects," "intends," and other similar words in relation to the Company is intended to identify forward-looking statements

    .
    The Company undertakes no obligation to continually update these forward-looking statements

    .

    These forward-looking statements are based on the Company's management's current beliefs, assumptions, expectations, estimates, projections and understanding of future events at the time the statements are made
    .
    These statements are not guarantees for future development and are subject to risks, uncertainties and other factors, some of which are beyond the control of the company and are difficult to predict

    .
    Accordingly, actual results may differ materially from those contained in forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal and social conditions

    .

    The Company, its directors and employee agents disclaim (a) any obligation to correct or update the forward-looking statements contained in this website; and (b) any responsibility
    .

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