INCB052793 / Incyte - LARVOL DELTA

A Phase 1/2 Study of the Oral Janus Kinase 1 Inhibitors INCB052793 and Itacitinib Alone or in Combination With Standard Therapies for Advanced Hematologic Malignancies. (PubMed, Clin Lymphoma Myeloma Leuk) - "Inhibition of JAK1 with INCB052793 (monotherapy or combination therapy) or itacitinib plus azacitidine did not demonstrate clinically meaningful responses in these patients with hematopoietic malignancies."

Combination therapy • Journal • P1/2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Multiple Myeloma • Myelodysplastic Syndrome • Oncology

Selective Inhibition of JAK1 Primes STAT5-Driven Human Leukemia Cells for ATRA-Induced Differentiation. (PubMed, Target Oncol) - "JAK1i+ ATRA lead to decreases in cell cycle followed by myeloid differentiation and cell death in human leukemias. These findings highlight potential uses of ATRA-based differentiation therapy of non-M3 human leukemia."

Journal • Acute Myelogenous Leukemia • Acute Promyelocytic Leukemia • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Leukemia • Myelofibrosis • Oncology • Polycythemia Vera • Thrombocytopenia • JAK1 • STAT5

INCB052793, a JAK1 selective inhibitor, is highly efficacious in PDX and xenograft models of acute myeloid leukemia (AML) expressing elevated endogenous pSTAT3/pSTAT5 (AACR 2018) - "Since azacitidine and cytarabine are standards of care for the treatment of AML, the efficacy of INCB052793 was benchmarked against optimal dosing regimens of these agents. The combination of INCB052793 with cytarabine showed superior efficacy in comparison to single agents in the MOLM-16 xenograft model, and combinatorial studies are in progress in additional AML models. These findings suggest the therapeutic potential of INCB052793 as a single agent and in combination with standard of care chemotherapeutic regimens for the management of AML."

Preclinical • Acute Myelogenous Leukemia

An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2; N=83; Terminated; Sponsor: Incyte Corporation; Completed ➔ Terminated

Clinical • Trial termination • Bladder Cancer • Breast Cancer • Gastrointestinal Cancer • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Oncology • Pancreatic Cancer • Triple Negative Breast Cancer

An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2; N=83; Completed; Sponsor: Incyte Corporation; Active, not recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Feb 2019

Clinical • Trial completion • Trial completion date

An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2; N=83; Active, not recruiting; Sponsor: Incyte Corporation; Trial completion date: Nov 2019 ➔ Jul 2019

Clinical • Trial completion date

An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies (clinicaltrials.gov) - P1/2; N=80; Active, not recruiting; Sponsor: Incyte Corporation; Trial completion date: Jun 2019 ➔ Nov 2019

Clinical • Trial completion date

Expanded Access Use of INCB052793 to Treat a Single Patient With Myelofibrosis (clinicaltrials.gov) - P; N=N/A; No Longer Available; Sponsor: Incyte Corporation

Clinical • New trial

The anti-myeloma effects of the selective JAK1 inhibitor (INCB052793) alone and in combination in vitro and in vivo. (PubMed, Ann Hematol) - "Tumor-bearing mice receiving combinations of INCB with carfilzomib, bortezomib, dexamethasone, or lenalidomide showed significantly smaller tumors when compared to vehicle control and mice treated with single agents. These results provide further support for the clinical evaluation of INCB052793 alone and in combination treatment for MM patients."

Journal • Preclinical

"Selective JAK1 inhibitor (INCB052793) shows anti-#myeloma effects alone and in combination both in vitro and in vivo: https://t.co/z28BqIL7uD." (@Myeloma_Doc)

Preclinical