tamgiblimab (IBI-939) / Innovent Biologics - LARVOL DELTA

A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2023 | Trial primary completion date: Sep 2023 ➔ Jan 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ Jun 2023 | Trial primary completion date: Sep 2023 ➔ Jan 2023

Combination therapy • Metastases • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A study to evaluate the safety, tolerability, and efficacy of IBI939 in combination with sintilimab in patients with previously untreated locally advanced unresectable or metastatic PD-L1–selected non–small-cell lung cancer (NSCLC): Updated efficacy and safety results. (ASCO 2023) - P1 | "With longer follow-up time, IBI939 plus sintilimab demonstrated durable PFS benefit and manageable safety profile in PD-L1 TPS ≥ 50% NSCLC patients with no prior systemic treatment. Clinical trial information: NCT04672369."

Clinical • Combination therapy • Metastases • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • PD-L1 • TIGIT

Innovent Updates Phase 1b Data of IBI939 (Anti-TIGIT Monoclonal Antibody) Combined with Sintilimab in Previously Untreated PD-L1-selected NSCLC at the 2023 ASCO Annual Meeting (PRNewswire) - P1b | N=42 | NCT04672369 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...updated the Phase 1b efficacy and safety results of IBI939 (anti-TIGIT antibody) combined with sintilimab (anti-PD-1 antibody) in previously untreated PD-L1-selected NSCLC without sensitizing mutations at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.....With median progression free survival (PFS) follow-up of 12.2 months in the experimental arm and 11.3 months in the control arm, respectively, median PFS per investigator was 13.2 months (95%CI: 6.7-16.5) and 6.4 months (95%CI: 1.4-NA), and the hazard ratio (HR) between two arms was 0.62; 96.4% patients in the experimental arm and 71.4% patients in the control arm experienced treatment-related adverse event (TRAE). Each arm occurred one treatment-emergent adverse event (TEAE) leading to end of treatment. No TEAE leading to death occurred in the experimental arm."

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

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

A Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer (NSCLC) (ESMO-IO 2022) - P1 | "The incidence of TRAEs was 85.7% vs 71.4% (2 and 5 pts experienced ≥ grade 3 events in each arm), respectively. The most common TRAEs were hypothyroidism (35.7%), aspartate aminotransferase increased (21.4%), blood urea increased (17.9%), hyperthyroidism (17.9%) in arm A. Immune-related AEs (determined by the investigator) were reported in 64.3% of pts in arm A and 50.0% of pts in arm B. Conclusions IBI939 plus sintilimab demonstrated improved PFS benefit and manageable safety profile in PD-L1 TPS ≥ 50% NSCLC patients with no prior systemic treatment."

Clinical • Combination therapy • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TIGIT

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1a | N=34 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | N=270 ➔ 34 | Trial completion date: Dec 2023 ➔ May 2022

Enrollment change • Metastases • Trial completion • Trial completion date • Oncology • Solid Tumor • TIGIT

Innovent Presents Phase Ib Clinical Data of IBI939 (Anti-TIGIT Monoclonal Antibody) in Previously Untreated PD-L1-selected NSCLC at the 2022 European Society For Medical Oncology Immuno-Oncology Congress (PRNewswire) - P1b | N=42 | NCT04672369 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "Innovent Biologics...announced that clinical data of IBI939 (anti-TIGIT monoclonal antibody) is presented at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO)....As of October 15th, 2022, 42 pts were randomized (2:1) to receive IBI939 plus sintilimab (experimental arm) or sintilimab monotherapy (control arm).....The median follow-up duration was 11.0 mos (95%CI, 9.6-11.3) in experimental arm and 9.8 mos (95%CI, 8.1-10.9) in control arm. Confirmed objective response rate (ORR) was 64.3% vs 57.2% and the disease control rate (DCR) was 85.7% vs 78.6% in experimental arm and control arm, respectively. The median PFS was 11.2 mos (95%CI, 6.7-NA) in experimental arm vs 6.4 mos (95% CI, 1.4-NA) in control arm (HR: 0.55)."

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

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

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1a | N=270 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2021 ➔ Jun 2022

Enrollment closed • Trial primary completion date • Oncology • Solid Tumor • TIGIT

A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial primary completion date: Sep 2022 ➔ Sep 2023

Combination therapy • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial primary completion date: Sep 2022 ➔ Sep 2023

Combination therapy • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Innovent Announced Financial Results for Full Year Ended December 31, 2020 and Corporate Progress (PRNewswire) - “The Company plans to enter phase III or pivotal clinical trial this year for 1L MDS for IBI-188…The Company plans to obtain proof-of-concept (PoC) data for IBI-322 in 2021…The Company has completed phase 1b enrollment for IBI-110 and will obtain PoC data in 2021. The potential first-in-class PD- L1/LAG-3 bispecific antibody has also received IND approval recently, and the Company will start Phase 1 study in 2021…In TIGIT area: the TIGIT monoclonal antibody IBI-939 has entered Phase 1b study, with plan to obtain PoC data in 2021. The Company also submitted the IND application for its PD-1/TIGIT bispecific antibody IBI-321 recently, and plans to start clinical study in 2021.”

New P1 trial • New P3 trial • P1 data • Myelodysplastic Syndrome • Oncology • Solid Tumor

A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • Combination therapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1a; N=270; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology

A Study to Evaluate the Safety , Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • Combination therapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

IBI-939 + sintilimab: Preliminary data from P1 trial (NCT04353830) for advanced malignant tumors in H1 2021 (Innovent Biologics) - Virtual R&D Day 2020

P1 data • Oncology • Solid Tumor

IBI-939: Preliminary data from P1 trial (NCT04353830) for advanced malignant tumors in H1 2021 (Innovent Biologics) - Virtual R&D Day 2020

P1 data • Oncology • Solid Tumor

Innovent Announces Financial Results for Six Months Ended June 30, 2020 and Corporate Progress (PRNewswire) - "Post-reporting period (expected) milestones: (i) IBI-310: Enrolled the first patient for a Phase 1 study in previously treated HCC in July 2020, and expect to complete the patient enrolment for Phase 1b study in 2020; (ii) IBI-939: Submit IND application for a Phase 1 study in the U.S. by the end of 2020; (iii) IBI-322: To initiate Phase 1 study and dose the first patient in the U.S. in 2020."

Enrollment status • IND • Trial initiation date • Hepatocellular Cancer • Oncology

Innovent announces first patient dosed in a phase 1 clinical trial of anti-TIGIT monoclonal antibody in China (PRNewswire) - "Innovent Biologics...announced that the first patient has been successfully dosed in a Phase 1 clinical trial (CIBI939A101) of anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) recombinant fully human monoclonal antibody drug candidate (IBI939) in China. CIBI939A101 is a Phase 1 clinical study conducted in China to evaluate IBI939 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial anti-tumor efficacy of IBI939, either as monotherapy or in combination with TYVYT® (sintilimab injection)..."

Enrollment open • Oncology

"Innovent $IVBXF starts China study of new anti-Tigit MAb IBI-939 https://t.co/9eO7FZAGdp PR: https://t.co/uGe5lNN3G8 $RCUS $RHHBY $MRK" (@JacobPlieth)

A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors (clinicaltrials.gov) - P1a; N=270; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • New P1 trial • Oncology