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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5640 - Phase I study of BI 754111 (anti-LAG-3) plus BI 754091(anti-PD-1) in patients (pts) with advanced solid cancers, followed by expansion in pts with microsatellite stable metastatic colorectal cancer (mCRC), anti-PD-(L)1-pretreated non-small-cell lung cancer (NSCLC) and other solid tumors

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Topics

Clinical Research

Tumour Site

Presenters

Melissa Johnson

Citation

Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288

Authors

M.L. Johnson1, M.R. Patel2, S.V. Ulahannan3, A. Hansen4, B. George5, Q.S. Chu6, M. Elgadi7, M. Ge8, C. Duffy8, R. Graeser9, S. Khedkar10, S.F. Jones11, H. Burris1

Author affiliations

  • 1 Medical Oncology, Sarah Cannon/Tennessee Oncology, 37203 - Nashville/US
  • 2 Medical Oncology, Sarah Cannon/Florida Cancer Specialists, Sarasota/US
  • 3 Medical Oncology, Sarah Cannon/Stephenson Cancer Center, Oklahoma City/US
  • 4 Medical Oncology, Princess Margaret Cancer Center, M5G 2M9 - Toronto/CA
  • 5 Medical Oncology, Medical College of Wisconsin, Milwaukee/US
  • 6 Medical Oncology, University of Alberta Cross Cancer Institute, T6G 1Z2 - Edmonton/CA
  • 7 Oncology, Boehringer Ingelheim (Canada) Ltd, L7L 5H4 - Burlington/CA
  • 8 Oncology, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield/US
  • 9 Transl. Medicine + Clin. Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Rhein/DE
  • 10 Pharmacovigilance, Sarah Cannon Development Innovations, Nashville/US
  • 11 Oncology, Sarah Cannon, Nashville/US
More

Resources

Abstract 5640

Background

Lymphocyte-activation gene 3 (LAG-3) is a negative regulator of immune response implicated in T cell exhaustion and tumor immune escape. Available data demonstrate that tumor-derived T cells frequently co-express the PD-1 and LAG-3 co-inhibitory receptors and that dual blockade of the LAG-3 and PD-1 pathways results in more potent reactivation of T-cell function and anti-tumor immune response than blockade of the individual pathway. BI 754091 and BI 754111 are monoclonal IgG4Pro antibodies (mAbs) against PD-1 and LAG-3, respectively. In this Phase I study, we investigate the safety, tolerability, PK, and preliminary efficacy of the combination of these 2 mAbs.

Trial design

This 2-part, open-labeled, non-randomized ongoing study consists of dose escalation in pts with advanced solid tumors followed by expansion cohorts in pts with NSCLC, microsatellite stable (MSS) mCRC, or any PD-1/PD-L1 pretreated solid tumor with high tumor mutational burden (TMB-H) and/or high microsatellite instability and/or DNA mismatch repair deficiency (MSI-H/MMRd). Dose escalation in pts with solid tumors started at 4mg q3w BI 754111 and was guided by Bayesian Logistic Regression Method. All dose levels of BI 754111 were co-administered with 240 mg q3w BI 754091 (the BI 754091 RPIID selected from 1381.1 phase I [Johnson, et al. ASCO-SITC 2017 abstract 212]). Enrollment in the solid tumor dose escalation portion is nearly complete. The expansion phase will use a combination dose selected from the solid tumor dose escalation. Primary endpoints in the dose escalation are the number of pts with dose-limiting toxicities and the combination MTD. The primary endpoint of the dose expansion portion is the objective response rate.

Clinical trial identification

NCT03156114.

Legal entity responsible for the study

Boehringer Ingelheim Pharmaceuticals, Inc.

Funding

Boehringer Ingelheim Pharmaceuticals, Inc.

Editorial Acknowledgement

Disclosure

M. Elgadi: Employee: Boehringer Ingelheim (Canada) Ltd./Ltee. M. Ge, C. Duffy: Employee: Boehringer Ingelheim Pharmaceuticals, Inc. R. Graeser: Employee: Boehringer Ingelheim Pharma GmbH & Co. KG. All other authors have declared no conflicts of interest.

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