ABBV-184 / AbbVie - LARVOL DELTA

First-in-human clinical trial results with ABBV-184, a first-in-class T-cell Receptor/Anti-CD3 bispecific protein, in adults with Previously treated AML or NSCLC. (PubMed, Expert Rev Anticancer Ther) - P1 | "ABBV-184 was well tolerated and demonstrated preliminary evidence of CD3 engagement with transient cytokine increases and peripheral lymphocyte decreases. NCT04272203."

Journal • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pain • Solid Tumor • BIRC5

ABBV-184: A novel survivin-specific TCR/CD3 bispecific T cell engager is active against both solid tumor and hematological malignancies. (PubMed, Mol Cancer Ther) - "Consistent with the expression profile of survivin across a broad range of both hematological and solid tumors, treatment of AML and NSCLC cell lines with ABBV-184 results in T cell activation, proliferation, and potent redirected cytotoxicity of HLA-A2 positive target cell lines, both in vitro and in vivo, including patient-derived AML samples. These results indicate that ABBV-184 is an attractive clinical candidate for the treatment of patients with AML and NSCLC."

IO biomarker • Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5

A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers (clinicaltrials.gov) - P1 | N=14 | Terminated | Sponsor: AbbVie | Trial completion date: Aug 2021 ➔ Jun 2022 | Trial primary completion date: Aug 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] Phase 1 first-in-human study of ABBV-184 monotherapy in adult patients with previously treated acute myeloid leukemia or non-small cell lung cancer. (ASCO 2021) - P1 | "Biomarker assessments will include longitudinal profiling of peripheral blood immune cells and cytokines, analysis of HLA-A2 and survivin levels on AML bone marrow blasts and NSCLC tumor biopsies, and retrospective correlations of biomarker data with antitumor activity . Enrollment initiated in Sep 2020, with 7 patients enrolled as of Jan 2021."

Clinical • IO biomarker • Monotherapy • P1 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BIRC5

A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers (clinicaltrials.gov) - P1; N=14; Terminated; Sponsor: AbbVie; N=112 ➔ 14; Trial completion date: Jan 2024 ➔ Aug 2021; Recruiting ➔ Terminated; Trial primary completion date: Jan 2024 ➔ Aug 2021; Strategic considerations

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers (clinicaltrials.gov) - P1; N=112; Recruiting; Sponsor: AbbVie; Trial completion date: Oct 2022 ➔ Jan 2024; Trial primary completion date: Oct 2022 ➔ Jan 2024

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AbbVie to Showcase Breadth of Oncology Portfolio and Pipeline at the 2021 ASCO and EHA Annual Congresses (PRNewswire) - “AbbVie…will present results from 43 abstracts across 12 types of cancer during the upcoming virtual American Society of Clinical Oncology (ASCO) Annual Meeting (June 4-8) and the virtual European Hematology Association (EHA) congress (June 9-17)….Presentations include nine oral presentations (two at ASCO and seven at EHA) and 32 poster presentations (13 at ASCO and 19 at EHA).”

Clinical data • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

[VIRTUAL] ABBV-184: A novel survivin specific T cell receptor/CD3 bispecific therapeutic that targets both solid tumor and hematological malignancies (AACR-I 2020) - "ABBV-184: A novel survivin specific T cell receptor/CD3 bispecific therapeutic that targets both solid tumor and hematological malignancies"

Hematological Malignancies • Oncology • BIRC5

A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers (clinicaltrials.gov) - P1; N=112; Recruiting; Sponsor: AbbVie; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study to Determine Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose (RP2D) of Intravenous ABBV-184 in Adult Participants With Previously Treated Cancers (clinicaltrials.gov) - P1; N=112; Not yet recruiting; Sponsor: AbbVie

Clinical • New P1 trial