- |||||||||| 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, 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.
- |||||||||| Monjuvi (tafasitamab-cxix) / Incyte, parsaclisib (INCB50465) / Incyte
Phase classification, Trial completion date, Trial primary completion date, Combination therapy, Pan tumor: topMIND: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - Dec 19, 2023 P1/2, N=54, Active, not recruiting, Durable responses and overall manageable safety profile were demonstrated in patients with R/R MZL treated with parsaclisib monotherapy. Phase classification: P1b/2a --> P1/2 | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
- |||||||||| Monjuvi (tafasitamab-cxix) / Incyte, parsaclisib (INCB50465) / Incyte
Enrollment change, Combination therapy, Pan tumor: topMIND: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov) - Aug 8, 2023 P1b/2a, N=54, Active, not recruiting, Active, not recruiting --> Completed N=100 --> 54
- |||||||||| 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
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, parsaclisib (INCB50465) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
Enrollment closed: Parsaclisib With or Without Polatuzumab Vedotin Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - May 18, 2023 P1, N=50, Active, not recruiting, Trial completion date: Mar 2023 --> Dec 2023 Recruiting --> Active, not recruiting
- |||||||||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte, epacadostat (INCB024360) / Incyte
Biomarker, Clinical, Combination therapy, Tumor microenvironment, Metastases: Exploring the safety, effect on the tumor microenvironment, and efficacy of itacitinib in combination with epacadostat or parsaclisib in advanced solid tumors: a phase I study: https://t.co/0koLCSUxr5 by @jasonlukemd , Dr. Patricia M LoRusso @GarridoLagunaMD @ANaingMD et al. (Twitter) - May 10, 2023
- |||||||||| Jakafi (ruxolitinib) / Novartis, Incyte, parsaclisib (INCB50465) / Incyte
Enrollment closed: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) (clinicaltrials.gov) - Mar 15, 2023 P3, N=212, Active, not recruiting, PI3K, Myelofibrosis, Ruxolitinib Recruiting --> Active, not recruiting
- |||||||||| Review, Journal: Rise of the planet of rare anemias: An update on emerging treatment strategies. (Pubmed Central) - Jan 27, 2023
PNH treatment is moving from the intravenous anti-C5 eculizumab to its long-term analog ravulizumab, and to subcutaneous and oral proximal inhibitors (anti-C3 pegcetacoplan, factor D and factor B inhibitors danicopan and iptacopan)...Finally, the addition of eltrombopag significantly ameliorated AA outcomes, and data regarding the alternative agent romiplostim are emerging. The accelerated evolution of treatment strategies will need further effort to identify the best candidate for each treatment in the precision medicine era.
|