Publications by authors named "Baiyong Li"

Background: Ivonescimab is a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor, yielding promising clinical outcomes for patients with advanced non-small cell lung cancer in early-phase studies. We compared the efficacy and safety of ivonescimab with pembrolizumab in patients with programmed cell death ligand-1 (PD-L1)-positive advanced non-small cell lung cancer.

Methods: HARMONi-2 is a randomised, double-blind, phase 3 trial across 55 hospitals in China.

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Clinical studies have shown that combination therapy of PD-1 and VEGF antibodies significantly improves clinical benefit over PD-1 antibody alone in certain settings. Ivonescimab, an on-market tetravalent anti-PD-1/VEGF bispecific antibody, was designed to improve efficacy and safety over combo therapy. In this study, the mechanism of action is investigated.

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Programmed cell death protein-1 (PD-1) inhibitors plus chemotherapy have been the standard of care in the first-line treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma; however, the survival benefits are modest in patients with low programmed death ligand 1 (PD-L1) expression. Here we investigated the efficacy and safety of cadonilimab (PD-1/cytotoxic T lymphocyte antigen-4 (CTLA-4) bispecific antibody) plus chemotherapy as first-line treatment in G/GEJ adenocarcinoma. The prespecified interim analysis is reported here.

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Article Synopsis
  • * In this phase 3, double-blind trial, 445 women were randomly assigned to receive either cadonilimab with chemotherapy or a placebo with chemotherapy, with results measured over time for progression-free and overall survival.
  • * Findings showed that patients receiving cadonilimab experienced a median progression-free survival of 12.7 months compared to 8.1 months for the placebo group, along with improved overall survival,
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Randomized clinical trials (RCTs) of PCSK9 monoclonal antibody(mAb) specifically for Chinese patients have been limited. This multi-center RCT is to clarify the efficacy and safety of a novel mAb, Ebronucimab, in Chinese patients. Patients diagnosed with primary hypercholesterolemia, including Heterozygous Familial Hypercholesterolemia, or mixed dyslipidemia, were categorized by ASCVD risk and randomly assigned at a ratio of 2:1:2:1 to receive Ebronucimab 450 mg or matching placebo every 4 weeks (Q4W), or Ebronucimab 150 mg or matching placebo every 2 weeks (Q2W).

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  • The study investigates the safety and efficacy of anti-PD-1 monoclonal antibodies (mAbs), comparing traditional IgG4 frameworks with a potentially safer Fc-null IgG1 alternative to reduce adverse effects from Fc-Fc interactions.
  • Researchers conducted various binding tests and immune response assessments using different types of antibodies on tumor cells, using both in vitro experiments and mouse models.
  • Results indicated that IgG4, including the anti-PD-1 mAb nivolumab, negatively impacted immune responses like cell-mediated cytotoxicity, raising concerns about their effectiveness in cancer treatment.
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Penpulimab is an anti-programmed cell death-1 (PD-1) IgG1 antibody with no Fc gamma receptor (FcγR) binding activity, and thus theoretically reduced immune-related adverse events (irAEs) while maintaining efficacy. This single-arm, phase II trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma (NPC) who had failed two or more lines of previous systemic chemotherapy. Patients received 200-mg penpulimab intravenously every 2 weeks (4 weeks per cycle) until disease progression or intolerable toxicities.

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  • Patients with non-small cell lung cancer who experienced disease progression on EGFR tyrosine kinase inhibitors (TKIs), especially third-generation ones, have limited treatment options available.* -
  • The study aimed to compare the effectiveness of ivonescimab in conjunction with chemotherapy versus chemotherapy alone for patients with relapsed advanced or metastatic non-small cell lung cancer with EGFR variants.* -
  • Results showed that the median progression-free survival was significantly higher in the ivonescimab group (7.1 months) compared to the placebo group (4.8 months), indicating a promising benefit for those receiving ivonescimab.*
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Treatment with anti-programmed cell death protein 1 (PD-1) therapy and chemotherapy prolongs the survival of patients with unresectable advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The benefit from anti-PD-1 therapy is enriched in patients with programmed cell death 1 ligand 1 (PD-L1) combined positive score (CPS)-positive or CPS-high tumors compared with patients with PD-L1 CPS-negative or CPS-low tumors. In this phase 1b/2 study, we evaluated the efficacy and safety of cadonilimab, a bispecific antibody targeting PD-1 and cytotoxic T-lymphocyte antigen-4, plus chemotherapy as first-line treatment in patients with human epidermal growth factor receptor 2-negative unresectable advanced or metastatic gastric or GEJ adenocarcinoma.

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  • The study addresses the challenge of efficiently screening patients for responsiveness to immunotherapy in cancer treatment, specifically targeting PD1/CTLA4.
  • The research involved developing a bispecific antibody (AK104) labeled with radionuclide isotopes and employing immuno-PET imaging to visualize and evaluate the therapeutic impact on PD1/CTLA4-positive T cells in humanized mouse models.
  • Findings indicate that the I-AK104 antibody demonstrated high specificity and efficacy in targeting tumor-infiltrating T cells, suggesting it could be a valuable tool for identifying patients who would benefit from immunotherapy.
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Background: Studies showed that vascular endothelial growth factor (VEGF) inhibitors could improve therapeutic efficacy of PD-1/PD-L1 antibodies by transforming the immunosuppressive tumor microenvironment (TME) into an immunoresponsive TME. Ivonescimab is a first-in-class, humanized tetravalent bispecific antibody targeting PD-1 and VEGF-A simultaneously. Here, we report the first-in-human, phase 1a study of ivonescimab in patients with advanced solid tumors.

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Objective: This study was designed to assess the efficacy and safety of cadonilimab monotherapy, a first-in-class, bi-specific PD-1/CTLA-4 antibody, in patients with previously treated recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC).

Patients And Methods: This multicenter, open-label, single-arm, phase II clinical trial enrolled patients with R/M-NPC who had failed first-line platinum-based chemotherapy and second-line single agent or combined chemotherapy, and immunotherapy-naive. Patients received cadonilimab for 6 mg/kg once every 2 weeks (Q2W).

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Purpose: Immune checkpoint inhibitors (ICI) have been a potential treatment option for patients with cervical cancer in several clinical studies. We investigated the safety and efficacy of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, plus standard therapy for the first-line treatment of R/M CC (recurrent and/or metastatic cervical cancer).

Patients And Methods: Eligible patients were assigned to 3 cohorts: cohort A-15 (cadonilimab 15 mg/kg every 3 weeks (Q3W) plus chemotherapy), cohort A-10 (cadonilimb 10 mg/kg Q3W plus chemotherapy), and cohort B-10 (cadonilimab 10 mg/kg Q3W plus chemotherapy and bevacizumab).

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Introduction: Cadonilimab (AK104) is a first-in-class tetravalent bispecific antibody that targets both PD-1 and CTLA-4, showing a manageable safety profile and favorable clinical benefits. This study aimed to identify the biomarkers of clinical response and explore the immune response within the tumor microenvironment upon the AK104 therapy in advanced solid tumors.

Material And Methods: Gene expression profiles of paired pre- and post-treatment tumor tissues from twenty-one patients were analyzed.

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Background: Cadonilimab is a bispecific antibody that simultaneously targets programmed cell death receptor-1 and cytotoxic T lymphocyte-associated antigen-4. This study aimed to assess the safety and efficacy of cadonilimab plus anlotinib for the first-line treatment of advanced non-small cell lung cancer (NSCLC) without sensitizing EGFR/ALK/ROS1 mutations.

Methods: Patients received cadonilimab 15 mg/kg and 10 mg/kg every three weeks (Q3W) plus anlotinib at doses of 10 or 12 mg once daily for two weeks on a one-week-off schedule.

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Purpose: This multicenter, open-label, phase Ib/II study aimed to assess the efficacy and safety of cadonilimab, a humanized, tetravalent, bispecific antibody plus lenvatinib in first-line treatment of advanced hepatocellular carcinoma (aHCC).

Methods: Patients with histologically confirmed aHCC were included to receive either 6 mg/kg cadonilimab every 2 weeks plus lenvatinib (cohort A) or 15 mg/kg cadonilimab every 3 weeks plus lenvatinib (cohort B). The primary endpoint was objective response rate (ORR) by RECIST v1.

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Introduction: This study (HARMONi-5) aimed to evaluate the safety and efficacy of ivonescimab (a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor) as first- or second-line monotherapy in patients with advanced immunotherapy-naive NSCLC.

Methods: Eligible patients received intravenous ivonescimab 10 mg/kg every 3 weeks (Q3W), 20 mg/kg every 2 weeks (Q2W), 20 mg/kg Q3W, or 30 mg/kg Q3W. The primary end points were safety and objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.

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Article Synopsis
  • The study investigates cadonilimab, a bispecific antibody that targets PD-1 and CTLA-4, to enhance cancer treatment effectiveness and reduce toxicity compared to single-agent therapies.
  • In a phase 1 trial with 119 patients, the recommended dose was established at 6 mg/kg administered biweekly, with one case of dose-limiting toxicity and manageable side effects, primarily infusion-related reactions.
  • The overall response rate was 13.4%, with a median duration of response of 12.9 months, indicating cadonilimab is well tolerated and shows potential benefits for patients with advanced solid tumors.
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  • Immune checkpoint inhibitors like PD-1 and CTLA-4 have shown effectiveness in treating various cancers, prompting the study of cadonilimab, a bispecific antibody for patients with advanced solid tumors.
  • This multicenter trial in China included patients with specific eligibility criteria, assessing cadonilimab's safety and effectiveness through different dosage phases across cancers like cervical, esophageal, and liver cancer.
  • The primary focus was on determining safety during phase 1b and the objective response rate in phase 2, with results being documented and registered under ClinicalTrial.gov, indicating the study has concluded.
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Purpose: This study aimed to evaluate the efficacy and safety of cadonilimab (anti PD-1 and CTLA-4 bispecific antibody) in patients with previously treated metastatic non-small-cell lung cancer (NSCLC).

Methods: In this multicenter, open-label, phase Ib/II study, patients with previously treated NSCLC were enrolled in three different cohorts: Cohort A, patients who had failed previous platinum-based doublet chemotherapy and were immunotherapy naïve; Cohort B, patients who had failed previous platinum-based doublet chemotherapy and had primary resistance to immunotherapy (IO); Cohort C, patients who had failed previous platinum-based doublet chemotherapy and had acquired resistance to IO. Eligible patients were given cadonilimab 6 mg/kg intravenously every 2 weeks.

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Introduction: Interleukin-4 (IL-4) and interleukin-13 (IL-13) are two essential cytokines involved in the T helper 2 (Th2)-mediated inflammatory response to diseases, such as atopic dermatitis (AD). AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. This mAb inhibits the signaling of the IL-4 and IL-13 cytokines.

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Background: Inhibiting vascular endothelial growth factor (VEGF) function can improve the efficacy of immunotherapy by modulating the tumor immune microenvironment. AK112 is the first-in-class humanized IgG1 bispecific antibody targeting programmed death-1 (PD-1) and VEGF. This study aimed to evaluate the efficacy and safety of AK112 combined with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC).

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Clinical studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab (AK104) is a symmetric tetravalent bispecific antibody with a crystallizable fragment (Fc)-null design.

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Objectives: To evaluate the safety, tolerability, immunogenicity, and induced expression of skin biomarkers of AK111 injection after multiple administrations in subjects with moderate-to-severe plaque psoriasis.

Methods: This study is a randomized, double-blinded, placebo-parallel-controlled study using a dose escalation mode of multiple doses. A total of 48 subjects were sequentially randomized to receive each AK111 dose regimen (75 mg, 150 mg, 300 mg, 450 mg) or the corresponding placebo.

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Background: CD47 is a widely expressed transmembrane glycoprotein that delivers an antiphagocytic signal on macrophages through its interaction with SIRPα. CD47 is highly expressed in cancer cells and its overexpression is correlated with poor prognosis. CD47 blocking antibodies are actively being developed worldwide for cancer therapy, and the most challenging concern is associated with hematotoxicity.

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