parsaclisib (INCB50465) / Incyte 
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 3 Diseases   27 Trials   27 Trials   276 News 


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  • ||||||||||  parsaclisib (INCB50465) / Incyte
    Targeting the Hypoxic Microenvironment in Cutaneous Chronic Graft-Versus-Host Disease through PI3K? Inhibition (Room 6B (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1789;    
    inhibition reversed skin hypoxia, prevented the development of pathogenic TLS, and ameliorated cGVHD histopathology, suggesting PI3Kd inhibition emerges as a promising therapeutic approach, alleviating disease symptoms and addressing fundamental mechanisms of disease progression. These insights pave the way for innovative treatments targeting the hypoxic milieu in cutaneous cGVHD.
  • ||||||||||  New Agents in Marginal Zone Lymphoma (Level 3, 370 BE) -  Jul 5, 2024 - Abstract #SOHO2024SOHO_12;    
    P2
    The median overall survival (OS) was not reached.5 The ACE-LY-003 study evaluated acalabrutinib in 43 R/R MZL patients...The CITADEL-204 study evaluated PI3Kd inhibitor parsaclisib daily dosing in 72 R/R MZL patients.8 The ORR was 58% with a CR rate of 4.2%, a median DOR of 12.2 months, and a median PFS of 16.5 months...Umbralisib, a dual PI3Kd/casein kinase 1e inhibitor, was evaluated in 69 R/R MZL patients in the UNITY-NHL study.9 The ORR was 49% with a CR of 16%, and the median DOR and median PFS were not reached...The double-blinded, randomized, placebo-controlled phase III CHRONOS-3 trial evaluated copanlisib with rituximab vs. rituximab in CD20-positive indolent NHL (iNHL)...The Zuma-5 clinical trial evaluated axicabtagene ciloleucel in R/R iNHL and included 24 patients (16%) with R/R MZL.11 In patients with MZL, the ORR was 83% with a CR rate of 65%...Bispecific antibodies targeting CD20 and CD3 that redirect T cells to engage and eliminate malignant B cells and antibody-drug conjugates, such as loncastuximab tesirine, demonstrated excellent responses in FL and aggressive NHL; however, scarce data exist for MZL...Therefore, targeting of only one aberrant signaling pathway may not be sufficient to completely eliminate the tumor. Therefore, usage of combination therapies, including bispecific antibodies and antibody-drug conjugates, may represent the next step toward the cure of MZL patients.
  • ||||||||||  parsaclisib (INCB50465) / Incyte, Istodax (romidepsin) / Astellas, BMS
    Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy:  Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas (clinicaltrials.gov) -  May 1, 2024   
    P1,  N=5, Active, not recruiting, 
    There were no safety concerns that contributed to this decision. Recruiting --> Active, not recruiting | N=20 --> 5 | Trial primary completion date: Dec 2023 --> Dec 2024
  • ||||||||||  parsaclisib (INCB50465) / Incyte, Rituxan (rituximab) / Roche, Imbruvica (ibrutinib) / AbbVie, J&J
    P1 data, Journal, Combination therapy:  Safety and efficacy of parsaclisib in combination with rituximab, bendamustine?+?rituximab, or ibrutinib in patients with previously treated B-cell lymphoma: analysis of a phase 1 dose-finding study (CITADEL?112). (Pubmed Central) -  Apr 10, 2024   
    P1
    The phase 1 CITADEL-112 (NCT03424122) study assessed safety and efficacy of parsaclisib in combination with investigator choice standard of care (SOC; rituximab [Treatment A], rituximab plus bendamustine [Treatment B], or ibrutinib [Treatment C]) in 50 patients with R/R B-cell lymphoma. The most common treatment-emergent adverse events included neutropenia (62.5%, 50.0%, and 50.0% of patients in Treatments A, B, and C, respectively); diarrhea (37.5%) and anemia (31.3%) in Treatment A; abdominal pain, asthenia, diarrhea, and nausea (each 33.3%) in Treatment B; and increased alanine and aspartate aminotransferase (each 37.5%) in Treatment C. Objective responses were observed in 13 patients (81.3%) in Treatment A, 10 (55.6%) in Treatment B, and 8 (50.0%) in Treatment C. Parsaclisib combined with SOC therapies had an expected safety profile and promising efficacy in patients with R/R B-cell lymphomas.
  • ||||||||||  parsaclisib (INCB50465) / Incyte
    Trial completion:  AIHA: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (clinicaltrials.gov) -  Apr 10, 2024   
    P2,  N=25, Completed, 
    The most common treatment-emergent adverse events included neutropenia (62.5%, 50.0%, and 50.0% of patients in Treatments A, B, and C, respectively); diarrhea (37.5%) and anemia (31.3%) in Treatment A; abdominal pain, asthenia, diarrhea, and nausea (each 33.3%) in Treatment B; and increased alanine and aspartate aminotransferase (each 37.5%) in Treatment C. Objective responses were observed in 13 patients (81.3%) in Treatment A, 10 (55.6%) in Treatment B, and 8 (50.0%) in Treatment C. Parsaclisib combined with SOC therapies had an expected safety profile and promising efficacy in patients with R/R B-cell lymphomas. Active, not recruiting --> Completed
  • ||||||||||  parsaclisib (INCB50465) / Incyte, gedatolisib (PF-05212384) / Celcuity, buparlisib (AN2025) / Novartis, Adlai Nortye
    Journal:  A Long Way to Go: A Scenario for Clinical Trials of PI3K Inhibitors in Treating Cancer. (Pubmed Central) -  Mar 22, 2024   
    It is of inter-est with respect to efforts in the synthesis of a candidate anti-cancer drug, parsaclisib. The establishment of development indicators based on clinical trials for cancer treatment was useful to highlight the clinical investment in 3 new PI3K drugs and the advantages of combine therapy using FDA-approved drugs.
  • ||||||||||  parsaclisib (INCB50465) / Incyte
    Enrollment change, Trial withdrawal, Combination therapy:  Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov) -  Oct 16, 2023   
    P1,  N=0, Withdrawn, 
    Trial completion date: Jun 2025 --> Jul 2024 N=560 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  parsaclisib (INCB50465) / Incyte
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date:  Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (clinicaltrials.gov) -  Jul 3, 2023   
    P3,  N=13, Active, not recruiting, 
    Trial completion date: Feb 2024 --> Oct 2023 | Trial primary completion date: Feb 2024 --> Feb 2023 Recruiting --> Active, not recruiting | N=100 --> 13 | Trial completion date: Apr 2027 --> Apr 2024 | Trial primary completion date: Aug 2024 --> Apr 2023