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- || Review, Journal: JAK Be Nimble: Reviewing the Development of JAK Inhibitors and JAK Inhibitor Combinations for Special Populations of Patients with Myelofibrosis. (Pubmed Central) - Jun 8, 2022
In this review, we highlight several specific areas of unmet need within MF. Subsequently, we review agents that target those areas of unmet need, focusing specifically on the JAK inhibitors, momelotinib, pacritinib, itacitinib, and NS-018 as well as JAK inhibitor combination approaches using CPI-0610, navitoclax, parsaclisib, and luspatercept.
- ||| Jakafi (ruxolitinib) / Incyte, parsaclisib (INCB50465) / Incyte
Trial completion, Combination therapy: INCB 50465-201: A Study of INCB050465 in Combination With Ruxolitinib in Subjects With Myelofibrosis (clinicaltrials.gov) - Jun 6, 2022
P2, N=74, Completed, Sponsor: Incyte Corporation
Subsequently, we review agents that target those areas of unmet need, focusing specifically on the JAK inhibitors, momelotinib, pacritinib, itacitinib, and NS-018 as well as JAK inhibitor combination approaches using CPI-0610, navitoclax, parsaclisib, and luspatercept. Active, not recruiting --> Completed
- || parsaclisib (INCB50465) / Incyte
P1 data, Journal: Parsaclisib in Japanese patients with relapsed or refractory B-cell lymphoma (CITADEL-111): a phase 1b study. (Pubmed Central) - May 29, 2022
Objective response rate was 100% in follicular lymphoma (9 of 9 patients, including complete response in 2 patients [22.2%]) and marginal zone lymphoma (2 of 2 patients), and 16.7% in diffuse large B-cell lymphoma (1 of 6 patients). Results observed in Japanese patients with relapsed or refractory follicular or marginal zone lymphoma support further clinical development of parsaclisib in these patient populations.
- parsaclisib (INCB50465) / Incyte
LONG-TERM EFFICACY AND SAFETY RESULTS FROM AN ONGOING OPEN-LABEL PHASE 2 STUDY OF PARSACLISIB FOR THE TREATMENT OF AUTOIMMUNE HEMOLYTIC ANEMIA (AIHA) (Hall Lehar 1-2) - May 13, 2022 - Abstract #EHA2022EHA_2692;
P2, P3
Few therapies beyond steroids and rituximab are available...Concomitant corticosteroids (≤20 mg/d prednisone) were allowed...Conclusion Parsaclisib was generally well tolerated and resulted in Hgb improvements as early as Wk 2 that increased over 12 wk of treatment and were sustained through the extension period. Parsaclisib may be an effective oral treatment for AIHA, and a randomized, controlled phase 3 trial in wAIHA is now recruiting (NCT05073458).
- Jakafi (ruxolitinib) / Novartis, Incyte, parsaclisib (INCB50465) / Incyte
EFFICACY AND SAFETY OF PARSACLISIB-RUXOLITINIB COMBINATION THERAPY IN MYELOFIBROSIS PATIENTS WITH LOW VS HIGHER BASELINE PLATELET COUNT: A SUBGROUP ANALYSIS OF DATA FROM A PHASE 2 STUDY () - May 13, 2022 - Abstract #EHA2022EHA_2178;
P2
Given the acceptable safety profile and efficacy of add-on parsaclisib, MF patients with both low and higher PC may be able to benefit from parsaclisib-ruxolitinib combination therapy. Phase 3 trials in ruxolitinib-treated and ruxolitinib-naive patients are underway to further assess the combination of JAK and PI3K inhibitors.
- parsaclisib (INCB50465) / Incyte, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A PHASE 1 STUDY EVALUATING SAFETY AND EFFICACY OF PARSACLISIB IN COMBINATION WITH BENDAMUSTINE + OBINUTUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (CITADEL-102) () - May 13, 2022 - Abstract #EHA2022EHA_1504;
P1
Median DOR, PFS, and OS were not reached. Conclusion Parsaclisib in combination with bendamustine + obinutuzumab appears to have a manageable safety profile and demonstrated promising efficacy in pts with R/R FL.
- parsaclisib (INCB50465) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A PHASE 1 STUDY OF PARSACLISIB IN COMBINATION WITH RITUXIMAB, BENDAMUSTINE + RITUXIMAB, OR IBRUTINIB IN PATIENTS WITH PREVIOUSLY TREATED B-CELL LYMPHOMA (CITADEL-112): PRELIMINARY SAFETY RESULTS () - May 13, 2022 - Abstract #EHA2022EHA_1503;
P1
Parsaclisib dose interruption or dose reduction due to TEAEs occurred in 75.0% and 18.8% of pts, respectively, in Tmt A; 66.7% and 27.8% of pts, respectively, in Tmt B; and 56.3% and 18.8% of pts, respectively, in Tmt C. Conclusion Parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW can be safely combined with RIT, RIT + BEN, or IBR in pts with R/R B-cell lymphomas. The tolerability profile of the combination regimens was manageable, with no unexpected safety concerns.
- parsaclisib (INCB50465) / Incyte
TRIAL IN PROGRESS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF PARSACLISIB IN PATIENTS WITH PRIMARY WARM AUTOIMMUNE HEMOLYTIC ANEMIA () - May 13, 2022 - Abstract #EHA2022EHA_1344;
Patients who experience worsening wAIHA (defined as a ≥1-g/dL decrease in Hgb from prior assessment or development of new or worsening symptoms) can use rescue therapy (new or increased dose of corticosteroids, transfusions, intravenous immunoglobulin, or epoetin alfa); those who continue on rescue therapy after Week 6 will be considered nonresponders in the primary efficacy analysis...Results The study is currently open and recruiting. Conclusion This phase 3 study will provide valuable insight into the safety and efficacy of parsaclisib as a potential treatment for patients with primary wAIHA.
- ||| parsaclisib (INCB50465) / Incyte
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment. (clinicaltrials.gov) - May 3, 2022
P1, N=55, Recruiting, Sponsor: Incyte Corporation
Conclusion This phase 3 study will provide valuable insight into the safety and efficacy of parsaclisib as a potential treatment for patients with primary wAIHA. Active, not recruiting --> Recruiting | N=37 --> 55 | Trial completion date: Mar 2022 --> Jun 2022 | Trial primary completion date: Mar 2022 --> Jun 2022
- | parsaclisib (INCB50465) / Incyte
Trial completion date, Trial primary completion date: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov) - May 3, 2022
P2, N=31, Recruiting, Sponsor: Incyte Corporation
Active, not recruiting --> Recruiting | N=37 --> 55 | Trial completion date: Mar 2022 --> Jun 2022 | Trial primary completion date: Mar 2022 --> Jun 2022 Trial completion date: Aug 2025 --> Mar 2024 | Trial primary completion date: Aug 2025 --> Mar 2024
- || Review, Journal: Novel treatments for myelofibrosis: beyond JAK inhibitors. (Pubmed Central) - Apr 30, 2022
Specifically, we discuss agents that target epigenetic modification (pelabresib, bomedemstat), apoptosis (navitoclax, navtemdalin), signaling pathways (parsaclisib), bone marrow fibrosis (AVID200, PRM-151), in addition to other targets including telomerase (imetelstat), selective inhibitor of nuclear transport (selinexor), CD123 (tagraxofusp) and erythroid maturation (luspatercept). We end by providing commentary on the ongoing and future therapeutic development in myelofibrosis.
- || parsaclisib (INCB50465) / Incyte
Enrollment change, Trial withdrawal, Combination therapy: CITADEL-310: A Study of Parsaclisib, a PI3K? Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov) - Apr 28, 2022
P3, N=0, Withdrawn, Sponsor: Incyte Corporation
We end by providing commentary on the ongoing and future therapeutic development in myelofibrosis. N=596 --> 0 | Not yet recruiting --> Withdrawn
- parsaclisib (INCB50465) / Incyte
A phase II, multicenter, single-arm study of parsaclisib, a PI3Kδ inhibitor, in relapsed or refractory follicular lymphoma in China: Updated data from the study. (Available On Demand; 226) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2679;
P2
Parsaclisib demonstrated promising efficacy, and acceptable safety profile. These results suggest that parsaclisib could benefit 3rd or higher line Follicular lymphoma patients.
- Darzalex (daratumumab) / J&J, parsaclisib (INCB50465) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Efficacy of thrombopoietin receptor agonists in Evans syndrome: An international multicentre experience () - Apr 25, 2022 - Abstract #BSH2022BSH_145;
However, TPO-RAs use was complicated by a high occurrence of thrombotic events that may be also favoured by the underlying conditions. Additionally, TPO-RAs required a concomitant therapy in the majority of patients, suggesting that in ES autoimmune platelet destruction cannot be completely overcome by bone marrow stimulation.
- | Journal: An Innovation 10 Years in the Making: The Stories in the Pages of ACS Medicinal Chemistry Letters. (Pubmed Central) - Apr 23, 2022
Lett. this Topical Innovations article highlights five of these compounds: Ivosidenib, Siponimod, Glasdegib, Parsaclisib, and Dabrafenib.
- ||| Jakafi (ruxolitinib) / Incyte, parsaclisib (INCB50465) / Incyte
Trial completion date: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) (clinicaltrials.gov) - Apr 14, 2022
P3, N=212, Recruiting, Sponsor: Incyte Corporation
this Topical Innovations article highlights five of these compounds: Ivosidenib, Siponimod, Glasdegib, Parsaclisib, and Dabrafenib. Trial completion date: Dec 2024 --> May 2025
- || Review, Journal: SOHO State of the Art Updates and Next Questions: Novel Therapies in Development for Myelofibrosis. (Pubmed Central) - Apr 9, 2022
Novel biomarkers and additional clinical features are being sought to assess new agents and tailor emerging therapies to appropriate patients. New strategies are needed to optimize the design of clinical trials comparing novel combinations to standard agent monotherapy.
- || itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte, epacadostat (INCB024360) / Incyte
Biomarker, Clinical, P1 data, Journal, Combination therapy, Tumor microenvironment: 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. (Pubmed Central) - Apr 5, 2022
P1
New strategies are needed to optimize the design of clinical trials comparing novel combinations to standard agent monotherapy. Adverse events with JAK1 inhibition combined with either IDO1 or PI3Kδ inhibition were manageable, but the combinations demonstrated limited clinical activity or enhancement of immune activation in the tumor microenvironment.
- ||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte
Biomarker, Trial completion, Tumor microenvironment, Metastases: Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors (clinicaltrials.gov) - Mar 31, 2022
P1, N=159, Completed, Sponsor: Incyte Corporation
Adverse events with JAK1 inhibition combined with either IDO1 or PI3Kδ inhibition were manageable, but the combinations demonstrated limited clinical activity or enhancement of immune activation in the tumor microenvironment. Active, not recruiting --> Completed
- || parsaclisib (INCB50465) / Incyte
Trial completion, Enrollment change: To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment. (clinicaltrials.gov) - Mar 29, 2022
P1, N=21, Completed, Sponsor: Incyte Corporation
Active, not recruiting --> Completed Recruiting --> Completed | N=40 --> 21
- || Review, Journal: PI3K Inhibitors for the Treatment of Chronic Lymphocytic Leukemia: Current Status and Future Perspectives. (Pubmed Central) - Mar 26, 2022
Novel PI3Kis are under evaluation in early phase clinical trials. In this paper we present the mechanism of action, efficacy and toxicities of PI3Ki approved in the treatment of CLL and developed in clinical trials.
- ||| Jakafi (ruxolitinib) / Incyte, parsaclisib (INCB50465) / Incyte
Trial completion date: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) (clinicaltrials.gov) - Mar 23, 2022
P3, N=212, Recruiting, Sponsor: Incyte Corporation
In this paper we present the mechanism of action, efficacy and toxicities of PI3Ki approved in the treatment of CLL and developed in clinical trials. Trial completion date: Jun 2025 --> Dec 2024
- || parsaclisib (INCB50465) / Incyte
Enrollment closed: To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Renal Function and Renal Impairment. (clinicaltrials.gov) - Mar 15, 2022
P1, N=37, Active, not recruiting, Sponsor: Incyte Corporation
Trial completion date: Jun 2025 --> Dec 2024 Recruiting --> Active, not recruiting
- ||||| itacitinib (INCB039110) / Incyte, parsaclisib (INCB50465) / Incyte, epacadostat (INCB024360) / Incyte
Biomarker, Clinical, Combination therapy, Tumor microenvironment: New #JITC article: 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/qsjRucFXsm @ANaingMD @jasonlukemd @jordanberlin5 (Twitter) - Mar 14, 2022
- ||| Jakafi (ruxolitinib) / Incyte, parsaclisib (INCB50465) / Incyte
Trial completion date: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304) (clinicaltrials.gov) - Mar 10, 2022
P3, N=212, Recruiting, Sponsor: Incyte Corporation
Recruiting --> Active, not recruiting Trial completion date: Dec 2024 --> Jun 2025
- Jakafi (ruxolitinib) / Novartis, Incyte, parsaclisib (INCB50465) / Incyte
Efficacy and safety of parsaclisib-ruxolitinib combination therapy in myelofibrosis patients (Pts) with low vs higher baseline platelet count (PC): A subgroup analysis of data from a phase 2 study (E-Poster Website) - Mar 9, 2022 - Abstract #AACR2022AACR_6722;
P2
Add-on parsaclisib showed efficacy in pts from both low and higher baseline PC groups. Given the acceptable safety profile and efficacy of add-on parsaclasib, MF pts with both low and higher PC may be able to benefit from parsaclisib-ruxolitinib combination therapy.
- || Review, Journal: The Evolving Use of Phosphatidylinositol 3-Kinase Inhibitors for the Treatment of Chronic Lymphocytic Leukemia. (Pubmed Central) - Mar 5, 2022
Duvelisib is a p110γ/δ inhibitor with a similar efficacy and safety profile to idelalisib. Recent data indicate that umbralisib, a p110δ/CK-1ε dual inhibitor, is safe and effective when administered to patients with CLL.
- | parsaclisib (INCB50465) / Incyte
New P1/2 trial, Combination therapy: Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL (clinicaltrials.gov) - Feb 14, 2022
P1/2, N=30, Not yet recruiting, Sponsor: Fudan University
- ||||| parsaclisib (INCB50465) / Incyte
Trial initiation date: To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302) (clinicaltrials.gov) - Feb 9, 2022
P3, N=416, Not yet recruiting, Sponsor: Incyte Corporation
Recent data indicate that umbralisib, a p110δ/CK-1ε dual inhibitor, is safe and effective when administered to patients with CLL. Initiation date: Jan 2022 --> Jul 2022
- |||| parsaclisib (INCB50465) / Incyte
Clinical: Amitkumar Mehta, MD, discusses overall response rates from the CITADEL-205 study looking at parsaclisib for patients with relapsed/refractory mantle cell lymphoma. #MCL | @Lymphoma_MD https://t.co/ME9846glt5 (Twitter) - Feb 3, 2022
- | Libtayo (cemiplimab) / Sanofi, Regeneron, parsaclisib (INCB50465) / Incyte
Keeping Track Of Withdrawals: Libtayo, Parsaclisib Applications Pulled Due To Postmarketing Issues https://t.co/CZxh8mZpRK #PinkSheet (Twitter) - Jan 29, 2022
- |||| parsaclisib (INCB50465) / Incyte
Amitkumar Mehta, MD, discusses the role of parsaclisib and how it fits into the treatment landscape of relapsed/refractory mantle cell lymphoma. #MCL | @Lymphoma_MD https://t.co/7WBAJZcR5o (Twitter) - Jan 27, 2022
- || Clinical, P2 data, Journal: Emerging drugs for the treatment of myelofibrosis: phase II & III clinical trials. (Pubmed Central) - Jan 27, 2022
Ruxolitinib and fedratinib are approved JAK2 inhibitors that have produced meaningful benefits in terms of spleen reduction and symptom improvement, but there remain several unmet needs...Specifically, we cover novel JAK inhibitors (momelotinib and pacritinib), and agents that target bromodomain and extra-terminal domain (pelabresib), the antiapoptotic proteins BCL-2/BCL-xL (navitoclax), MDM2 (navtemadlin), phosphatidylinositol 3-kinase (parsaclisib), or telomerase (imetelstat)...Future evaluation of agents must be judged on their potential to modify disease progression, which current JAK2 inhibitors lack. Combination therapy, possibly with an immunotherapeutic agent might serve as key components of future myelofibrosis treatment options.
- ||| Rapalimus Gel (sirolimus gel) / Nobelpharma, parsaclisib (INCB50465) / Incyte
European regulatory: EU Filings For Parsaclisib & Sirolimus Gel Submitted For Rare Diseases https://t.co/MKM8BoKSwz #PinkSheet (Twitter) - Jan 27, 2022
- | parsaclisib (INCB50465) / Incyte
Trial completion date: A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111) (clinicaltrials.gov) - Jan 26, 2022
P1b, N=17, Active, not recruiting, Sponsor: Incyte Corporation
Combination therapy, possibly with an immunotherapeutic agent might serve as key components of future myelofibrosis treatment options. Trial completion date: Aug 2022 --> Jun 2023
- ||| parsaclisib (INCB50465) / Incyte
Enrollment change, Trial completion date, Trial primary completion date: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov) - Jan 26, 2022
P2, N=41, Recruiting, Sponsor: Incyte Corporation
Trial completion date: Aug 2022 --> Jun 2023 N=31 --> 41 | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
- || MCLA-145 / Merus, Incyte, parsaclisib (INCB50465) / Incyte
$INCY Incyte Provides Update on Parsaclisib and MCLA-145 https://t.co/F9mtMMtKV8 (Twitter) - Jan 25, 2022
- |||| parsaclisib (INCB50465) / Incyte
Enrollment open, Trial initiation date: Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (clinicaltrials.gov) - Jan 20, 2022
P3, N=100, Recruiting, Sponsor: Incyte Corporation
N=31 --> 41 | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025 Not yet recruiting --> Recruiting | Initiation date: Nov 2021 --> Feb 2022
- | parsaclisib (INCB50465) / Incyte
Preclinical, Journal: The PI3Kδ inhibitor parsaclisib ameliorates pathology and reduces autoantibody formation in preclinical models of systemic lupus erythematosus and Sjӧgren's syndrome. (Pubmed Central) - Jan 18, 2022
Parsaclisib reduced autoreactive B-cells and autoantibody levels, and significantly improved nephritis and salivary gland inflammation. These data provide the scientific rationale for PI3Kδ inhibition as a therapeutic strategy for treatment of B-cell-mediated antibody-driven autoimmune diseases.
- parsaclisib (INCB50465) / Incyte, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
A Phase 1 Study of Parsaclisib in Combination with Investigator Choice of Rituximab, Bendamustine + Rituximab, or Ibrutinib in Patients with Previously Treated B-Cell Lymphoma (CITADEL-112): Preliminary Safety Results (Salt Palace Convention Center Hall A) - Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_1283;
P1
Parsaclisib 20 mg QD for 8 weeks followed by 20 mg QW can be safely combined with RIT, RIT + BEN, or IBR in pts with R/R B-cell lymphomas. The tolerability profile of the combination regimens was manageable, with no unexpected safety concerns.
- parsaclisib (INCB50465) / Incyte, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A Phase 1 Study Evaluating Safety and Efficacy of Parsaclisib in Combination with Bendamustine + Obinutuzumab in Patients with Relapsed or Refractory Follicular Lymphoma (R/R FL) (CITADEL-102) (Salt Palace Convention Center Hall A) - Jan 9, 2022 - Abstract #TCTASTCTCIBMTR2022TCT_ASTCT_CIBMTR_1279;
P1
CITADEL-102 (NCT03039114) is an open-label phase 1 dose-finding study that investigated the safety and efficacy of parsaclisib in combination with bendamustine + obinutuzumab in pts with R/R FL following rituximab-containing regimens. Parsaclisib in combination with bendamustine + obinutuzumab appears to have a manageable safety profile and demonstrated promising efficacy in pts with R/R FL.
- | parsaclisib (INCB50465) / Incyte
Trial completion date, Trial primary completion date: Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213) (clinicaltrials.gov) - Dec 21, 2021
P2, N=40, Recruiting, Sponsor: Incyte Biosciences Japan GK
Parsaclisib in combination with bendamustine + obinutuzumab appears to have a manageable safety profile and demonstrated promising efficacy in pts with R/R FL. Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Mar 2024
- | parsaclisib (INCB50465) / Incyte
Trial completion date, Trial primary completion date: AIHA: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia (clinicaltrials.gov) - Dec 15, 2021
P2, N=25, Active, not recruiting, Sponsor: Incyte Corporation
Trial completion date: Mar 2024 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Mar 2024 Trial completion date: Dec 2023 --> Sep 2023 | Trial primary completion date: Dec 2023 --> Aug 2021
- |||| Jakafi oral (ruxolitinib) / Novartis, Incyte, parsaclisib (INCB50465) / Incyte
Clinical, Combination therapy: Also happening in the #ASH21 session 634: @AYacoub7 is discussing, “Subgroup Analysis from a Phase 2 Study of the Efficacy and Safety of Parsaclisib, a Selective PI3Kδ Inhibitor, in Combination with Ruxolitinib in Patients with Myelofibrosis (MF)” https://t.co/uJs5VyOcNo (Twitter) - Dec 13, 2021
- |||| parsaclisib (INCB50465) / Incyte
Ryan Lynch presents promising data our study of parsaclisib for R/R follicular #lymphoma with 78% ORR and median PFS 16m for daily dosed group. #ASH21 (Twitter) - Dec 13, 2021
- || parsaclisib (INCB50465) / Incyte
Well done on your parsaclisib data btw. Nicely presented. (Twitter) - Dec 13, 2021
- ||||| Jakafi oral (ruxolitinib) / Novartis, Incyte, parsaclisib (INCB50465) / Incyte
Clinical: Going on now at #ASH21, session 634: Dr. @ayacoub7 is presenting, "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ruxolitinib Plus Parsaclisib in Patients with JAK- and PI3K-Inhibitor Treatment–Naive Myelofibrosis” https://t.co/bYAPiNH8eG (Twitter) - Dec 13, 2021
- |||| parsaclisib (INCB50465) / Incyte
Clinical: Parsaclisib seems barely active in BTKi exposed pts. (Twitter) - Dec 12, 2021
- |||||| parsaclisib (INCB50465) / Incyte
Clinical, Monotherapy: 🔥CONGRESS #ASH21 @Lymphoma_MD @uabmedicine reported results from a cohort of BTKi–naive pts w/ R/R MCL treated with parsaclisib monotherapy in the CITADEL-205 study ➡️TEAEs occurred in 90.7% ➡️Grade ≥3 in 62.0% ➡️Most common grade ≥3 TEAEs diarrhea & neutropenia #leusm (Twitter) - Dec 12, 2021
- ||||| parsaclisib (INCB50465) / Incyte
P2 data: CITADEL-205, Phase II, #Parsaclisib in BTK-naive R/R #MCL ORR~70%, time to response ~ 8 weeks. Diarrhea/colitis/skin rash. #ASH21 #Lymphoma @Lymphoma_MD (Twitter) - Dec 12, 2021