IBI110 / Innovent Biologics - LARVOL DELTA

Neoadjuvant IBI110 and sintilimab in combination with chemotherapy in resectable locally advanced head and neck squamous cell carcinoma. (ASCO 2025) - P1/2 | "Clinical Trial Registration Number: NCT06494943 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Combination therapy • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

An update on the results of IBI110 (anti-LAG-3 antibody) plus sintilimab (anti-PD-1 antibody) in patients with advanced alveolar soft part sarcoma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Metastases • Alveolar Soft Tissue Sarcoma • Oncology • Sarcoma • Solid Tumor

A single-center phase II clinical study to evaluate the efficacy and safety of IBI110 in combination with sintilimab in the treatment of advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV). (ChiCTR) - P=N/A | N=30 | Completed | Sponsor: Beijing Cancer Hospital; Beijing Cancer Hospital

New trial • Alveolar Soft Tissue Sarcoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: Fudan University | Active, not recruiting ➔ Recruiting | Phase classification: P1 ➔ P1/2 | N=20 ➔ 27

Enrollment change • Enrollment open • Phase classification • Tumor mutational burden • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TMB

Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study. (PubMed, J Hematol Oncol) - P1a | "IBI110 monotherapy and in combination with sintilimab were well-tolerated in Chinese patients with advanced solid tumors. Encouraging efficacy of IBI110 in combination with sintilimab and chemotherapies was observed in sqNSCLC and GC."

Journal • P1 data • Gastric Cancer • Hematological Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • LAG3

Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study (J Hematol Oncol) - P1b/1b | N=268 | NCT04085185 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "In phase Ia dose escalation (n = 28), treatment-related adverse events (TRAEs) occurred in 67.9% patients and grade ≥ 3 TRAEs occurred in 21.4% patients. In phase Ib combination dose escalation (n = 45), TRAEs occurred in 75.6% patients and grade ≥ 3 TRAEs occurred in 22.2% patients. No dose-limiting toxicity (DLT) was observed....ORR in phase Ia/Ib dose escalation was 3.6% with IBI110 monotherapy and 14% with IBI110 plus sintilimab. In phase Ib combination dose expansion of IBI110 plus sintilimab and chemotherapy, unconfirmed and confirmed ORR in sqNSCLC (n = 20) was 80.0% (95% CI, 56.3–94.3) and 75.0% (95% CI, 50.9–91.3), respectively and in GC (n = 17) was 88.2% (95% CI, 63.6–98.5) and 70.6% (95% CI, 44.0-89.7), respectively."

P1 data • Gastric Cancer • Lung Non-Small Cell Squamous Cancer

Innovent Biologics (01801.HK) completes first patient dosing in China in clinical study of advanced malignant tumors [Google translation] (uSMART) - "Innovent Biologics...announced that the first patient in China was dosed in the Phase I clinical study of the company's independently developed recombinant fully human anti-lymphocyte activation gene 3 (LAG-3) monoclonal antibody (IBI-110). This clinical study is a clinical study conducted in China to evaluate the safety, tolerability and preliminary anti-tumor efficacy of IBI-110 alone or in combination with TYVYT, a recombinant fully human anti-PD-1 monoclonal antibody, in subjects with advanced malignant tumors."

Trial status • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Induction IBI110 and Sintilimab With Chemotherapy In LA HNSCC (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Fudan University

Combination therapy • Metastases • New P1 trial • Tumor mutational burden • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TMB

Efficacy and safety of IBI110 (anti-LAG-3 antibody) plus sintilimab (anti-PD-1 antibody) in patients with advanced alveolar soft part sarcoma: Results from a phase II study. (ASCO 2024) - "Co-inhibition of LAG-3 and PD-1 showed encouraging efficacy in pts with advanced ASPS. Compared to anti-PD-1 monotherapy, the combination treatment improved ORR in IO-naïve pts and restored IO effectiveness in previously IO-failed pts. The safety profiles were acceptable and manageable in all pts."

Clinical • Metastases • P2 data • Alveolar Soft Tissue Sarcoma • Diabetes • Dyslipidemia • Hypertriglyceridemia • Metabolic Disorders • Oncology • Sarcoma • Solid Tumor • Type 1 Diabetes Mellitus

Efficacy and Safety of IBI110 in Combination With Sintilimab Versus Sintilimab Alone in Neoadjuvant and Adjuvant Therapy of Radically Resectable Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=6 | Terminated | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=40 ➔ 6 | Trial completion date: Apr 2023 ➔ Dec 2023 | Recruiting ➔ Terminated; Development strategy adjustment

Combination therapy • Enrollment change • Trial completion date • Trial termination • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Biomarker analysis of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) and chemotherapy as 1L treatment for advanced squamous non-small cell lung cancer (sqNSCLC) (ESMO Asia 2023) - No abstract available

Biomarker • Combination therapy • IO biomarker • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IBI110 Combined With Sintilimab in Second-line Advanced or Metastatic Esophageal Squamous Cell Carcinoma(ESCC) (clinicaltrials.gov) - P2 | N=46 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University

Metastases • New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A Study of IBI110 in Combination With Sintilimab and Chemotherapy in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jun 2023 | Trial primary completion date: Jun 2023 ➔ Feb 2023

Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy and safety of IBI110 in combination with sintilimab and lenvatinib in first-line of advanced hepatocellular carcinoma: Preliminary results from a phase Ib study. (ASCO 2023) - P1a | "Background: Sintilimab plus bevacizumab has been approved as first-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC). In this phase Ib study, IBI110 in combination with sintilimab and lenvatinib as first line therapy demonstrated robust response and survival benefit with manageable safety profile in patients with advanced hepatocellular carcinoma. This combination therapy need to be further explored in this population. Clinical trial information: NCT04085185."

Clinical • Combination therapy • Metastases • P1 data • Cardiovascular • Endocrine Disorders • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Hypertension • Oncology • Solid Tumor • LAG3

Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: Updated results from a phase Ib study. (ASCO 2023) - P1a | "IBI110 in combination with sintilimab and XELOX demonstrated manageable safety and encouraging efficacy results in patients with first-line gastric adenocarcinoma. This is the first positive trial to show clinical benefits of a LAG3 plus PD-1 inhibitor combined with chemotherapy for this population. Clinical trial information: NCT04085185."

Clinical • Combination therapy • Metastases • P1 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2 • LAG3

Innovent Presents Phase 1b Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2023 ASCO Annual Meeting (PRNewswire) - P1b | N=268 | NCT04085185 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that Phase 1b clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in the first-line treatment of gastric cancer...are presented at the 2023...ASCO Annual Meeting...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."

P1 data • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Innovent Presents Phase 1b Clinical Data of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2023 ASCO Annual Meeting (PRNewswire) - P1b | N=268 | NCT04085185 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that Phase 1b clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in the first-line treatment of...first-line treatment of hepatocellular carcinoma are presented at the 2023...ASCO Annual Meeting...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."

P1 data • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Innovent Announces Clinical Data of Multiple Trials Will be Presented at the 2023 ASCO and EHA Annual Meetings (PRNewswire) - "Innovent Biologics...announces that about 30 accepted abstracts of clinical data from multiple trials in relation to TYVYT® (sintilimab injection), olverembatinib (BCR-ABL TKI), IBI326 (equecabtagene autoleucel), IBI376 (parsaclisib), IBI110 (anti-LAG-3 monoclonal antibody), IBI939 (anti-TIGIT monoclonal antibody) and IBI351 (KRASG12C inhibitor) will be presented at the upcoming international medical conferences."

Clinical data • Colorectal Cancer • Follicular Lymphoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Head and Neck Cancer • Hematological Malignancies • Hepatocellular Cancer • Hodgkin Lymphoma • Liver Cancer • Lung Cancer • Lymphoma • Multiple Myeloma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Thoracic Cancer

Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in advanced squamous non-small cell lung cancer (sqNSCLC): updated results of the phase Ib study (ESMO-IO 2022) - P1a | "The preliminary results of IBI110 combined with sintilimab and chemotherapy (paclitaxel plus carboplatin, TP) (combination therapy) in pts with treatment-naive sqNSCLC were previously presented (Caicun Zhou et al. The median PFS was not reached. Conclusions IBI110 combined with sintilimab and chemotherapy in advanced sqNSCLC continues showing robust anti-tumor activity and favorable safety."

Clinical • Combination therapy • P1 data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with sintilimab (anti-PD-1 mAb) in first-line advanced squamous non-small cell lung cancer (sqNSCLC): Initial results from a phase Ib study. (ASCO 2022) - P1a | " Eligible patients with previously untreated, unresectable, locally advanced or metastatic NSCLC were enrolled in cohort D. Patients received IBI110 200mg IV Q3W and sintilimab 200mg IV Q3W until disease progression, unacceptable toxicity or death, in combination with chemo regimen (paclitaxel 175 mg/m2 plus carboplatin) IV Q3W for 4 cycles. IBI110 in combination with sintilimab in first-line advanced sqNSCLC showed promising anti-tumor activity with acceptable safety. The study is still ongoing."

Clinical • Combination therapy • IO biomarker • P1 data • Alopecia • Anemia • Diabetes • Hematological Disorders • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • LAG3 • PD-L1

Efficacy and safety of IBI110 in combination with sintilimab in first-line advanced HER2-negative gastric cancer or gastroesophageal junction cancer: Preliminary results from a phase Ib study. (ASCO 2022) - P1a | "Background: Sintilimab plus XELOX has been proven to be efficacious in the first line treatment of gastric cancer. In this phase Ib study, IBI110 in combination with sintilimab and chemotherapy was well tolerated in the first line treatment of G/GEJ AC and the clinical benefit need more follow up time to be elucidated."

Clinical • Combination therapy • P1 data • Cardiovascular • Coronary Artery Disease • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Innovent Presents Phase Ib Clinical Data Update of IBI110 (Anti-LAG-3 Monoclonal Antibody) at the 2022 European Society For Medical Oncology Immuno-Oncology Congress (PRNewswire) - P1b | N=20 | "Innovent Biologics...announced that updated clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in advanced squamous non-small cell lung cancer (sqNSCLC) is presented at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO)....20 treatment naïve sqNSCLC patients received IBI110 (200 mg, Q3W) combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. As of the data cutoff date of Oct 25, 2022, median follow-up time was 12.0 (95% CI, 11.9 -13.1) months, 16 patients achieved partial response (PR), the objective response rate (ORR) was 80%; the 12-month progression free survival (PFS) rate was 60.0% (95% CI, 35.7-77.6), the median PFS was not reached; the 12-month overall survival (OS) rate was 85.0% (95% CI, 60.4-94.9)."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

A Platform Study of Novel Immunotherapy Products in Participants With Previously Treated Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P1b/2 | N=0 | Withdrawn | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=108 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Innovent Announced Clinical Data of Multiple Trials Will be Presented at the 2022 ESMO-IO and ASH Annual Meetings (PRNewswire) - "Innovent Biologics...announced that clinical data from multiple trials in relation to TYVYT® (sintilimab injection), olverembatinib (BCL-ABL TIK), IBI188 (anti-CD47 monoclonal antibody), IBI110 (anti-LAG-3 monoclonal antibody) and IBI939 (anti-TIGIT monoclonal antibody) will be presented at the upcoming international medical conferences."

Clinical data • P1 data • P2 data • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

IBI110 (anti-LAG-3 mAb) as a single agent or in combination with sintilimab (anti-PD-1 mAb) in patients with advanced solid tumors: Updated results from the phase Ia/Ib dose-escalation study. (ASCO 2022) - P1a | "IBI110 alone or plus sintilimab demonstrated acceptable safety profile and promising antitumor activity in patients with advanced solid tumors."

Clinical • Combination therapy • P1 data • Anemia • Endocrine Disorders • Endometrial Cancer • Hematological Disorders • Immune Modulation • Inflammation • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • LAG3