dezapelisib (INCB040093) / Incyte - LARVOL DELTA

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Aug 2024 ➔ Jan 2025 | Trial primary completion date: Aug 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Feb 2024 ➔ Aug 2024 | Trial primary completion date: Feb 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Feb 2023 ➔ Feb 2024 | Trial primary completion date: Feb 2023 ➔ Feb 2024

Trial completion date • Trial primary completion date • Hematological Malignancies • Mantle Cell Lymphoma • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1 | N=121 | Active, not recruiting | Sponsor: Incyte Corporation | Trial completion date: Dec 2021 ➔ Feb 2023 | Trial primary completion date: Dec 2021 ➔ Feb 2023

Trial completion date • Trial primary completion date • Hematological Malignancies • Mantle Cell Lymphoma • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1; N=121; Active, not recruiting; Sponsor: Incyte Corporation; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Mantle Cell Lymphoma • Oncology

Incyte clinical portfolio to be featured in 23 abstract presentations at the 2015 ASCO and EHA Annual Meetings (Incyte Press Release) - "[Incyte to present]...Results from ongoing proof-of-concept trial of PI3Kδ inhibitor INCB40093 as monotherapy and in combination with JAK1 inhibitor INCB39110 in B-cell malignancies, including Hodgkin lymphoma...[and]...Follow-up results from pivotal RESPONSE trial of ruxolitinib in patients with uncontrolled polycythemia vera, showing 83% of patients were still receiving ruxolitinib at a median exposure of 111 weeks."

Anticipated conference • Anticipated P1 data • Anticipated P3 data • Hematological Malignancies • Oncology

Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) - P1; N=121; Active, not recruiting; Sponsor: Incyte Corporation; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

INCB050465 (Parsaclisib), a Novel Next-Generation Inhibitor of Phosphoinositide 3-Kinase Delta (PI3Kδ). (PubMed, ACS Med Chem Lett) - "The unique structure of 20 contains a pyrazolopyrimidine hinge-binder in place of a purine motif that is present in other PI3Kδ inhibitors, such as idelalisib (1), duvelisib (2), and INCB040093 (3, dezapelisib). Parsaclisib (20) is a potent and highly selective inhibitor of PI3Kδ with drug-like ADME properties that exhibited an excellent in vivo profile as demonstrated through pharmacokinetic studies in rats, dogs, and monkeys and through pharmacodynamic and efficacy studies in a mouse Pfeiffer xenograft model."

Journal

Phase 1 study of the PI3Kδ inhibitor INCB040093 ± JAK1 inhibitor itacitinib in relapsed/refractory B-cell lymphoma. (PubMed, Blood) - P1; "INCB040093 with/without itacitinib was tolerated and active in this study, and is a promising treatment strategy for patients with select R/R B-cell lymphomas. ClinicalTrials.gov: #NCT01905813."

Journal • P1 data