The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).

开始日期2024-08-13

申办/合作机构

Novartis Pharmaceuticals Canada, Inc.

ISRCTN10750305

/ Completed临床1期

An Open-Label, Single-Dose, Single-Period Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-pelabresib in Healthy Male Subjects

开始日期2022-11-22

申办/合作机构

Constellation Pharmaceuticals, Inc.

NCT05391022

/ Completed临床1期

A Phase 1, 2-Part Study to Evaluate the Effect of Food on Pharmacokinetics of Pelabresib (CPI-0610) and the Effect of Pelabresib on QTc in Patients With Advanced Malignancies

Phase 1 2-part study to evaluate the effect of food on pharmacokinetics of pelabresib (CPI-0610) and the effect of pelabresib on QTc in patients with advanced malignancies

开始日期2021-07-20

申办/合作机构

Constellation Pharmaceuticals, Inc.

100 项与 Pelabresib 相关的临床结果

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100 项与 Pelabresib 相关的转化医学

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100 项与 Pelabresib 相关的专利（医药）

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项与 Pelabresib 相关的文献（医药）

2025-12-01·Current Hematologic Malignancy Reports

Highlights from MPN Asia 2025: Advances in Molecular Pathogenesis and Therapeutic Strategies in Myeloproliferative Neoplasms

Review

作者: Yacoub, Abdulraheem ; Li, Bing ; Mascarenhas, John O ; Duan, Minghui ; Kiladjian, Jean-Jacques ; Hou, Hsin-An ; Hobbs, Gabriela S ; Lee, Sung-Eun ; Bose, Prithviraj ; Rampal, Raajit ; Tashi, Tsewang ; Qin, Albert ; Huang, Jian ; Gill, Harinder ; Hasselbalch, Hans C ; Mesa, Ruben A ; Kirito, Keita ; Yu, Lennex Hsueh-Lin ; Xiao, Zhijian ; Shimoda, Kazuya ; Prchal, Josef T

PURPOSE OF REVIEW:

This report summarizes key insights from the 8th Annual International Symposium on Myeloproliferative Neoplasms (MPN Asia 2025). The symposium brought together global experts to discuss advancements in MPN biology, diagnostics, and therapeutics, with a focus on emerging molecular understanding, novel treatment strategies and real-world data.

RECENT FINDINGS:

Molecular profiling has become essential in MPN risk stratification and therapeutic decision-making. High-risk mutations (e.g., ASXL1, TP53) and inflammatory pathways (e.g., IL-17, NF-κB) were shown to correlate with disease progression and transformation. Interferon-based therapy is increasingly used in younger, low-risk, or treatment-naïve patients, and is also being investigated in myelofibrosis and essential thrombocythemia. Ropeginterferon alfa-2b, a novel interferon-based therapy, demonstrated durable clinical efficacy in polycythemia vera. Its high initial-dose and accelerated titration (HIDAT) regimen led to fast achievement of complete hematologic response, rapid reductions in JAK2V617F allele burden, and high complete molecular response rate. Combination regimens involving ruxolitinib and agents such as pelabresib, selinexor, and interferon showed potential for enhanced efficacy. Population-based studies from Asia contributed regional epidemiological and treatment data, reinforcing the role of real-world evidence. Modern prognostic models such as MIPSS70+ v2.0 and GIPSS were discussed for more precise risk prediction. Preliminary findings also suggest ropeginterferon alfa-2b may be a safe option during pregnancy. MPN Asia 2025 highlighted the growing role of molecular diagnostics and targeted therapeutics in the management of MPNs. Ropeginterferon alfa-2b has emerged as a therapeutic potential across the MPN spectrum. Its early use and personalized strategies are increasingly recognized. Real-world data and regional insights are shaping a more nuanced, globally informed approach to MPN care.

2025-05-01·NATURE MEDICINE

Pelabresib plus ruxolitinib for JAK inhibitor-naive myelofibrosis: a randomized phase 3 trial

Article

作者: Mesa, Ruben ; Chraniuk, Dominik ; Harrison, Claire N ; Boxhammer, Rainer ; Gerds, Aaron T ; Lavie, David ; Lee, Sung-Eun ; Li, Qing ; Talpaz, Moshe ; Oh, Stephen T ; Lucchesi, Alessandro ; Mascarenhas, John ; Grosicki, Sebastian ; Álvarez-Larrán, Alberto ; Patriarca, Andrea ; Brown, Barbara ; Scandura, Joseph M ; Vannucchi, Alessandro M ; Abruzzese, Elisabetta ; Harris, Morgan ; Bose, Prithviraj ; Jegg, Anna-Maria ; Kays, Sarah-Katharina ; Kuykendall, Andrew T ; Gupta, Vikas ; Palandri, Francesca ; Kiladjian, Jean-Jacques ; Rampal, Raajit K

Janus kinase (JAK) inhibitors provide limited depth and durability of response in myelofibrosis. We evaluated pelabresib-a bromodomain and extraterminal domain (BET) inhibitor-plus ruxolitinib (a JAK inhibitor) compared with placebo plus ruxolitinib as first-line therapy. In this phase 3 study (MANIFEST-2), JAK inhibitor-naive patients with myelofibrosis were randomized 1:1 to pelabresib 125 mg once daily (QD; 50-175 mg QD permitted) for 14 days followed by a 7-day break (21-day cycle), or to placebo in combination with ruxolitinib 10 or 15 mg twice daily (BID; 5 mg QD-25 mg BID permitted). Primary endpoint was reduction in spleen volume of ≥35% from baseline at week 24. Key secondary endpoints were absolute change in total symptom score (TSS) and TSS50 response (≥50% reduction in TSS from baseline at week 24). The primary endpoint was met in 65.9% of patients randomized to pelabresib-ruxolitinib (n = 214) versus 35.2% to placebo-ruxolitinib (n = 216) (difference, 30.4%; 95% confidence interval (CI), 21.6, 39.3; P < 0.001). Absolute change in TSS was -15.99 versus -14.05 (difference, -1.94; 95% CI, -3.92, 0.04; P = 0.0545) and TSS50 was achieved in 52.3% versus 46.3% (difference, 6.0%; 95 CI, -3.5, 15.5) with pelabresib-ruxolitinib versus placebo-ruxolitinib. Exploratory analyses of proinflammatory cytokine amounts and bone marrow morphology showed greater improvement with the combination. Thrombocytopenia and anemia were the most common treatment-emergent adverse events, occurring in 52.8% (13.2% grade ≥3) versus 37.4% (6.1% grade ≥3) and 44.8% (23.1% grade ≥3) versus 55.1% (36.5% grade ≥3), respectively. Pelabresib in combination with ruxolitinib is well tolerated, improves signs of underlying myelofibrosis pathobiology and provides substantial clinical benefit over standard-of-care JAK inhibitor monotherapy. ClinicalTrials.gov identifier: NCT04603495 .

2025-03-01·HEMATOLOGICAL ONCOLOGY

Managing Myelofibrosis: Matching Advances in Treatments With Clinical Unmet Needs

Review

作者: Chan, Tze Wei ; Than, Hein ; Huang, Feng‐Ju ; Billa, Gauri ; Lee, Lai Heng

ABSTRACT:

Myelofibrosis (MF) is characterized by anemia, constitutional symptoms, hepatosplenomegaly and bone marrow fibrosis, and is associated with poor survival. The janus kinase inhibitor (JAKi) ruxolitinib has been the mainstay of treatment for over a decade. Despite demonstrated symptomatic and quality of life improvement, unmet clinical needs persist. A literature review identified promising novel targeted treatment options in MF using pre‐set selection criteria (available Phase 2 or 3 data, minimum enrollment of 50 patients, trial end date within the last 5 years). Available data for novel and approved therapies were extracted, tabulated, and analyzed for clinical relevancy. From an initial shortlist of 48, 16 retained molecules were selected for inclusion. Other JAKi (pacritinib, momelotinib, jaktinib) address treatment‐related cytopenia, expanding the therapeutic utility of this class of agents to patients with baseline anemia or thrombocytopenia. Novel candidates exploit multiple molecular pathways, and offer the potential to improve the management of MF‐associated cytopenia (imetelstat, pelabresib, navitoclax, selinexor, luspatercept, sotatercept, elritercept, LCL161, bomedemstat) and recover bone marrow fibrosis (imetelstat, pelabresib, navitoclax and bomedemstat). It remains to be seen if these newer agents can induce any remission in MF and enable patients to come off therapy, but the future is beginning to look much brighter.

119

项与 Pelabresib 相关的新闻（医药）

2025-07-18

·FiercePharma

Bristol Myers braves failed Reblozyl phase 3, plans FDA talks for potential anemia expansion

The Reblozyl trial flop adds to a concerning trend of clinical woes at Bristol Myers Squibb this year. Despite a phase 3 flop, Bristol Myers Squibb—encouraged by “clinically meaningful results” and bruised by three other recent pivotal trial failures—still plans to discuss a potential approval filing with the FDA for the company’s Reblozyl.Friday, the New Jersey pharma announced that a phase 3 study evaluating Reblozyl in patients with myelofibrosis-associated anemia who required red blood cell transfusions did not meet its main goal. The patients were also on background treatment with a JAK inhibitor such as Incyte’s Jakafi.The trial, coded Independence, failed to show a statistically significant difference for Reblozyl versus placebo in freeing patients of transfusions during a consecutive 12-week period, starting within the first 24 weeks of treatment.The P-value for the primary endpoint’s analysis landed at 0.0674, narrowly missing the maximum 0.05 threshold that’s typically considered statistically significant. The exact bar for this trial is unclear.Nevertheless, BMS noted that the data favored Reblozyl, with the drug showing a “numerical and clinically meaningful improvement” in transfusion independence, in line with previous findings from a phase 2 study.Several secondary measures also showed a “clinically meaningful” benefit for the BMS drug, according to the company. These include a higher number of patients who achieved at least a 50% reduction—and by at least four red blood cell units—in transfusion burden.However, the company’s July 18 release didn’t mention how Reblozyl fared on the trial’s key secondary endpoint, which is weighing the number of patients who became transfusion-independent over any consecutive 16-week period, beginning within 24 weeks of treatment. In response to a Fierce Pharma request for clarification, a BMS spokesperson said the company plans to share full data from the study in a future peer-reviewed setting. Based on the data, BMS said it will engage with the FDA and the European Medicines Agency about potentially applying for marketing approvals. The company believes “the totality of these results, including meaningful improvements in transfusion burden and hemoglobin levels, support the potential to address an unmet need in patients who have few treatment options,” Anne Kerber, BMS’ head of development in hematology, oncology and cell therapy, said in a July 18 release.The Reblozyl trial flop adds to a concerning trend of clinical woes at BMS this year. All four of the pivotal life-cycle management trials that have read out this year for BMS’s existing drugs have turned up negative.The losing streak started in February with the LAG-3/PD-1 combo Opdualag flunking as an adjuvant treatment for resected stage 3 or 4 melanoma. Then, the heart med Camzyos couldn’t move the needle in non-obstructive hypertrophic cardiomyopathy.A few days later, the company’s Cobenfy stumbled as an adjunctive treatment for inadequately controlled schizophrenia. That leaves the closely watched Adept-2 trial for Cobenfy in Alzheimer’s disease psychosis as the only planned phase 3 readout this year for an in-market BMS drug that has not reported outcomes.The pivotal success drought is troublesome because all those four drugs have been tasked with helping BMS navigate a huge patent cliff. During a presentation at the J.P. Morgan Healthcare Conference in January, BMS CEO Chris Boerner highlighted the four drugs, plus the CAR-T therapy Breyanzi, as five products key to the company’s growth portfolio, which was expected to exceed 50% of BMS’s revenues in 2025. Reblozyl is already approved by the FDA to treat two other types of anemia related to beta thalassemia and lower-risk myelodysplastic syndromes (MDS). BMS has projected the drug, acquired in its Celgene buyout, can reach $4 billion or more in peak sales. In the first quarter of 2025, Reblozyl sales jumped 35% year over year, reaching $478 million.It’s not the end of the road for the first-in-class erythroid maturation agent. While BMS shoots for potential submissions in myelofibrosis-associated anemia, the phase 3 Element-MDS trial testing Reblozyl in nontransfusion-dependent MDS anemia is expected to read out in 2027. And the drug is also being evaluated in alpha thalassemia.Elsewhere in the myelofibrosis universe, Novartis recently took a hit as a safety signal has delayed—if not completely derailed—the Swiss pharma’s regulatory plan for its BET inhibitor candidate pelabresib, which was obtained from its $2.9 billion MorphoSys buyout.Incyte recently shared phase 1 data for its BET inhibitor INCB057643, used with or without Jakafi, in patients with relapsed or refractory myelofibrosis and other myeloid neoplasms. The company recently scrapped development of its ALK-2 inhibitor zilurgisertib in myelofibrosis-related anemia after a failed phase 1/2 trial.Editor's Note: The story was updated with a BMS response to Fierce's inquiry.

临床3期临床结果临床2期并购临床1期

2025-07-03

·同写意

自免口服药安全困境破局？加科思BET抑制剂JAB-8263力压JAK，三重机制有望开启长期给药治疗新时代

免疫疗法临床结果

2025-05-15

·GlobeNewswire-Health Care

New Novartis data at ASCO and EHA showcase momentum of pioneering portfolio with promising pipeline

NATALEE subanalysis evaluates Kisqali in pre-menopausal early breast cancer patients, amid rising diagnosis rates in younger patients Pluvicto analysis and Scemblix ASC4START primary endpoint results provide insights into use in earlier settingsFabhalta APPULSE-PNH full results build on Phase III program, reporting new data from expanded PNH population in adults switching from anti-C5Ianalumab Phase II data in immune thrombocytopenia and longer-term pelabresib Phase III data in myelofibrosis show breadth of pipeline in hematologic diseases Basel, May 15, 2025 – Novartis will present data from 60 company or investigator sponsored abstracts that have the potential to change clinical practice, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2025 Congress. “The breadth of our oncology and hematology portfolio – anchored by Kisqali, Pluvicto, Scemblix and Fabhalta – demonstrates our leadership in both solid tumors and hematologic diseases,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “At ASCO and EHA, we will present new data on these priority medicines as well as updates from our pipeline and our industry-leading radioligand therapy research.” Novartis will also highlight its US partnerships with the National Football League (NFL), Alliance for Breast Cancer Policy, and ZERO Prostate Cancer, which encourage people to make proactive decisions about their health and advance patient-centered policy solutions to help improve outcomes. “We're witnessing a profound shift in how people move through their cancer journey, with cancer diagnoses occurring at younger ages and, simultaneously, older patients living longer and approaching aging with new vigor,” said Victor Bultó, President, US, Novartis. “As a leader in driving medical advances in oncology, we have the responsibility to also make a difference in areas beyond treatment innovation. By partnering across the ecosystem, our goal is to advance the conversation around earlier detection and meet the evolving needs of this next generation of cancer patients.” Key highlights of data accepted by ASCO include: Medicine Abstract Title Abstract Number/ Presentation Details Kisqali®(ribociclib)* Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age Abstract #516Rapid OralJune 1, 8:00 – 9:30am CDT Kisqali®(ribociclib) Real-world (RW) analysis of characteristics and risk of recurrence (ROR) in Black patients (pts) with HR+/HER2− early breast cancer (EBC) eligible for NATALEE Abstract #527Poster PresentationJune 2, 9:00am – 12:00pm CDT Kisqali®(ribociclib) Adjuvant WIDER: A phase 3b trial of ribociclib (RIB) + endocrine therapy (ET) as adjuvant treatment (tx) in a close-to-clinical-practice patient (pt) population with HR+/HER2− early breast cancer (EBC) Abstract #TPS617Poster PresentationJune 2, 9:00am – 12:00pm CDT Kisqali®(ribociclib) First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive hormone receptor (HR)+/HER2− advanced breast cancer (ABC): A subgroup analysis of patients (pts) with or without liver metastases (mets) from RIGHT Choice Abstract #1069Poster PresentationJune 2, 9:00am – 12:00pm CDT Scemblix®(asciminib) Efficacy and safety of asciminib (ASC) in patients (pts) with chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI): Interim analysis (IA) of the phase 2 ASC2ESCALATE trial Abstract #6516Rapid OralMay 30, 1:00 – 2:30pm CDT Scemblix® (asciminib) Primary endpoint results of the phase 3b ASC4START trial of asciminib (ASC) vs nilotinib (NIL) in newly diagnosed chronic phase chronic myeloid leukemia (CML-CP): Time to treatment discontinuation due to adverse events (TTDAE) Abstract #6501Oral PresentationJune 2, 3:00 – 6:00pm CDT Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) Clinical outcomes of prompt versus deferred 177Lu-PSMA-617 initiation for metastatic castration-resistant prostate cancer (mCRPC) based on prior androgen receptor pathway inhibitor (ARPI) and taxane chemotherapy exposure: a real-world PRostatE Cancer dISease observatION (PRECISION) data platform analysis Abstract #e17030Online Publication Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: a real-world PRostatE Cancer dISease observatION (PRECISION) data platform analysis Abstract #e17035Online Publication Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) PSMA-delay castration (DC): An open-label, multicenter, randomized phase 3 study of [177Lu]Lu-PSMA-617 versus observation in patients with metachronous PSMA-positive oligometastatic prostate cancer (OMPC) Abstract #TPS5127Poster PresentationJune 2, 9:00am – 12:00pm CDT Key highlights of data accepted by EHA include: Medicine Abstract Title Abstract Number/ Presentation Details Fabhalta®(iptacopan) APPULSE-PNH: Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin (Hb) increases in patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) and Hb ≥10 g/dL on anti-C5 therapy Abstract #S183Oral PresentationJune 13, 5:00 – 6:15pm CEST Fabhalta®(iptacopan) The 2-year safety and efficacy of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria (PNH) from APPLY- and APPOINT-PNH studies who entered the roll-over extension program (REP) Abstract #PF660Poster PresentationJune 13, 6:30 – 7:30pm CEST Scemblix®(asciminib) Asciminib (ASC) shows superior tolerability vs nilotinib (NIL) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Primary endpoint results of the phase (Ph) 3b ASC4START trial Abstract #S166Oral PresentationJune 13, 5:00 – 6:25pm CEST Scemblix®(asciminib) Improved patient-reported outcomes (PROs) with asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST wk 48 analysis Abstract #PS1588Poster PresentationJune 14, 6:30 – 7:30pm CEST Scemblix®(asciminib) Interim analysis (IA) results from ASC2ESCALATE support asciminib (ASC) as a treatment (Tx) option in chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI) Abstract #PF595Poster PresentationJune 13, 6:30 – 7:30pm CEST Pelabresib(DAK539) Pelabresib in combination with ruxolitinib for janus kinase inhibitor-naive patients with myelofibrosis: 72-week follow-up with long-term efficacy outcomes of the phase III MANIFEST-2 study Abstract #S223Oral PresentationJune 12, 5:00 – 6:15pm CEST Ianalumab(VAY736) A Phase 2 Study of Ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapy (VAYHIT3) Abstract #S312Oral PresentationJune 15, 11:00am – 12:15pm CEST Rapcabtagene autoleucel (YTB323) Rapcabtagene Autoleucel (YTB323) in patients with relapsed/refractory diffuse large B-cell lymphoma: A phase II trial clinical update Abstract #PF1152Poster PresentationJune 13, 6:30 – 7:30pm CEST Novartis in oncologyThe Novartis oncology strategy focuses on people living with cancer and those who care for them, from loved ones to clinical care teams, including their providers. For the past 30+ years, the aim has been to extend and improve lives by discovering differentiated, innovative and practice-changing medicines for patients. As Novartis reimagines medicine, it collaborates with a wide range of patient advocacy groups and supports education, early cancer screening and diagnosis, all while innovating at a rate that is unparalleled in the industry. With approximately 35 research and development projects across solid tumors, hematology and radioligand therapy (RLT), Novartis is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # *Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals. Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

临床2期ASCO会议临床3期临床结果

100 项与 Pelabresib 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
白血病	临床3期	美国	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
白血病	临床3期	比利时	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
白血病	临床3期	意大利	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
白血病	临床3期	荷兰	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
白血病	临床3期	英国	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
实体瘤	临床3期	美国	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
实体瘤	临床3期	比利时	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
实体瘤	临床3期	意大利	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
实体瘤	临床3期	荷兰	Novartis Pharmaceuticals Canada, Inc.	2024-08-13
实体瘤	临床3期	英国	Novartis Pharmaceuticals Canada, Inc.	2024-08-13

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04603495 (MANIFEST-2, EHA2025)	临床3期	骨髓纤维化	-	Pelabresib+Ruxolitinib	鬱壓鹽選蓋窪範窪獵廠(夢獵製選蓋糧齋艱築構) = 27.4% vs 41.1% in the Pelabresib+Ruxolitinib arm vs the Placebo+Ruxolitinib arm 範廠顧壓獵獵餘膚選築 (鬱糧鹹網鬱遞膚廠積構 ) 更多	积极	2025-05-14
				Placebo+Ruxolitinib
NCT04603495 (MANIFEST-2, Pubmed \| Nat Med)	临床3期	骨髓纤维化一线	-	Pelabresib 125 mg QD + Ruxolitinib 10 or 15 mg BID	鑰廠鏇繭範蓋憲鏇齋獵(觸蓋憲蓋夢糧窪襯窪顧) = 積鹽衊壓遞淵積範醖窪蓋衊積製範選鹹鬱夢鏇 (糧夢簾選蓋選繭鹹獵積 ) 更多	积极	2025-03-10
				Placebo + Ruxolitinib 10 or 15 mg BID	鑰廠鏇繭範蓋憲鏇齋獵(觸蓋憲蓋夢糧窪襯窪顧) = 鹹鏇觸鑰鹽簾簾襯壓顧蓋衊積製範選鹹鬱夢鏇 (糧夢簾選蓋選繭鹹獵積 ) 更多
NCT04603495 (MANIFEST-2, CTgov)	临床3期	原发性血小板增多症后骨髓纤维化 \| 真性红细胞增多症后骨髓纤维化 \| 原发性骨髓纤维化	430	Ruxolitinib+Pelabresib (Pelabresib + Ruxolitinib)	製夢鬱願鑰醖顧築繭夢 = 夢鬱鬱衊襯醖鏇窪艱憲範餘鏇壓廠膚艱艱願網 (構網鬱製醖網夢鬱鏇範, 艱繭願廠壓蓋繭積襯糧 ~ 顧艱觸艱範觸憲淵鏇艱) 更多	-	2024-10-28
				Placebo+Ruxolitinib (Placebo + Ruxolitinib)	製夢鬱願鑰醖顧築繭夢 = 顧獵鏇餘窪觸艱窪築築範餘鏇壓廠膚艱艱願網 (構網鬱製醖網夢鬱鏇範, 網製構鬱淵衊壓鏇鏇遞 ~ 網遞齋壓鹽醖衊艱壓餘) 更多
SOHO2024	N/A	骨髓纤维化	-	Pelabresib+ruxolitinib	膚蓋淵網淵憲蓋構鏇鹹(積繭壓廠餘餘簾醖築壓) = 43.9% vs 54.7% 遞壓夢選製製蓋簾蓋蓋 (衊鑰鑰壓襯窪選鹹壓簾 ) 更多	-	2024-09-04
				Placebo+ruxolitinib
NCT04603495 (MANIFEST-2, ASCO2024) 人工标引	临床3期	骨髓纤维化	430	Pelabresib + Ruxolitinib	膚築範糧窪窪齋願淵選(觸網鬱遞夢膚觸壓築選) = 襯膚構獵簾繭壓構製窪夢憲鹽夢糧壓範繭繭鹽 (築鹹壓齋鏇淵構構壓壓 ) 更多	积极	2024-05-24
				Placebo + Ruxolitinib	膚築範糧窪窪齋願淵選(觸網鬱遞夢膚觸壓築選) = 艱獵範鬱選淵醖憲鬱簾夢憲鹽夢糧壓範繭繭鹽 (築鹹壓齋鏇淵構構壓壓 ) 更多
NCT04603495 (MANIFEST-2, EHA2024) 人工标引	临床3期	骨髓纤维化 JAK2	-	Pelabresib+Ruxolitinib	網築齋衊糧鹹築糧積積(壓衊願範製築繭憲壓遞) = 鹽鹽壓獵鏇憲範構鹹夢窪醖糧餘獵憲繭齋壓網 (壓餘鏇鏇糧膚鏇醖膚衊, -36.5 ~ -31.1) 更多	积极	2024-05-14
				Placebo+Ruxolitinib	網築齋衊糧鹹築糧積積(壓衊願範製築繭憲壓遞) = 積壓簾鹽淵糧鬱願醖淵窪醖糧餘獵憲繭齋壓網 (壓餘鏇鏇糧膚鏇醖膚衊, -23.7 ~ -17.9) 更多
NCT02158858 (MANIFEST, Pubmed) 人工标引	临床1期	髓系肿瘤 Protein Expression Markers	44	Pelabresib	鹽簾蓋鹹糧遞壓襯獵醖(繭糧壓遞遞鬱範鏇窪鹽) = nausea, decreased appetite, and fatigue 構構鹽鬱夢廠鹹積憲膚 (夢構積構蓋選範願憲窪 ) 更多	积极	2024-01-23
				Pelabresib (acute leukemia)
NCT04603495 (MANIFEST-2, Corporate Publications) 人工标引	临床3期	原发性骨髓纤维化	430	Pelabresib + Ruxolitinib	艱齋襯鑰襯願獵顧襯繭(顧糧醖網齋餘壓遞糧糧) = 繭窪壓廠艱夢製襯選鏇鹹膚壓壓夢願遞憲蓋鏇 (憲鹹齋醖鬱餘衊觸積築 ) 达到更多	积极	2023-11-20
				Placebo + Ruxolitinib	艱齋襯鑰襯願獵顧襯繭(顧糧醖網齋餘壓遞糧糧) = 憲鬱鹽獵糧鹹構醖糧築鹹膚壓壓夢願遞憲蓋鏇 (憲鹹齋醖鬱餘衊觸積築 ) 达到更多
NCT02158858 (MANIFEST, EHA2023)	临床2期	急性髓性白血病 \| 血小板减少症 \| 血液肿瘤 ... 更多	84	PELA + RUX	製窪選鬱襯鹹簾壓衊艱(糧鏇鹽襯齋齋獵膚壓積) = 齋衊構襯鹽鹹構廠積網壓淵夢夢構壓夢網遞膚 (製壓網廠觸築繭齋衊築 ) 更多	-	2023-06-08
NCT02158858 (MANIFEST, EHA2023)	临床2期	原发性骨髓纤维化追加	87	PELA + RUX	蓋艱觸醖製遞觸網醖鑰(網壓觸範廠獵選鏇夢壓) = 願憲艱鹹構鹹鑰鹹蓋蓋願構願構遞膚範鬱淵齋 (蓋顧衊鹹壓蓋構窪齋獵 ) 更多	-	2023-06-08