RegulationFast Track (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (JP), Orphan Drug (KR), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (US)

Structure

Molecular FormulaC29H28ClF3N6O

InChIKeyBWTNNZPNKQIADY-UHFFFAOYSA-N

CAS Registry1114544-31-8

Clinical Trials associated with Ponatinib Hydrochloride

NCT06207123 / RecruitingPhase 1/2IIT

A Phase I/II Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory T-ALL/LBL

The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.

Start Date13 Sep 2024

Sponsor / Collaborator

The University of Chicago

NCT06390306 / Not yet recruitingNot ApplicableIIT

The Efficacy and Safety of Third Generation Tyrosine Kinase Inhibitors Combined With Azacitidine and B-cell Lymphoma-2 Inhibitor in Patients With Myeloid Blast Phase Chronic Myeloid Leukemia

This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP).

Start Date01 Jul 2024

Sponsor / Collaborator

Peking University People's Hospital

[+6]

NCT04845035 / WithdrawnPhase 2IIT

A Phase II Study Using a BFM Regimen Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

This study will combine a standard, pediatric-inspired, chemotherapy regimen with the tyrosine kinase inhibitors (TKIs) Dasatinib and Ponatinib to treat adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
There are two age groups/cohorts:
participants aged 18 to 59 years
participants aged 60 years and older
One tyrosine kinase inhibitor (TKI), either Dasatinib or Ponatinib, will be administered in each of the respective chemotherapy cycles. The TKI (either Dasatinib or Ponatinib) administered in a given cycle of chemotherapy will be dictated by the given cycle's standard chemotherapy, in order to minimize overlapping side effects of the chemotherapy and TKI.
The dosages of the standard chemotherapy agents, as well as the tyrosine kinase inhibitors (TKIs)--Dasatinib and Ponatinib--have been adjusted for each age group to allow continuous administration of these TKIs.

Start Date01 Jan 2024

Sponsor / Collaborator

Rogel Cancer Center: University of Michigan

[+1]

100 Clinical Results associated with Ponatinib Hydrochloride

100 Translational Medicine associated with Ponatinib Hydrochloride

100 Patents (Medical) associated with Ponatinib Hydrochloride

1,108

Literatures (Medical) associated with Ponatinib Hydrochloride

01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY

Multi-targeted action of rooibos may protect against ischaemic stroke-induced neurological deficit and endothelial dysfunction

Article

Author: Pretorius, L ; Ross, K S ; Smith, C

ETHNOPHARMACOLOGICAL RELEVANCE:

Indigenous use communities in the Western Cape (South Africa) where Aspalathus linearis (Brum.f) R.Dahlgren - or rooibos - grows naturally, has a long history of using rooibos for medicinal purposes. Apart from its well-known antioxidant effect, the Cederberg community in particular has been using rooibos as a treatment for high blood pressure. Given the detrimental effects of high blood pressure on endothelial cells, rooibos may either directly or indirectly affect vascular health. This, together with more recent reports of neuroprotective effects, may position rooibos as complementary medicine in related vascular conditions such as ischaemic stroke.

AIMS OF THE STUDY:

The study aimed to evaluate the potential benefit of acute administration of unfermented rooibos, on vascular health in a larval zebrafish model of stroke.

MATERIALS AND METHODS:

Stroke was induced via 24-h ponatinib exposure, in the presence or absence of an aqueous solution of an ethanolic extract of unfermented Rooibos (GreenOxithin™). The magnitude of stroke was assessed by monitoring larval locomotion and thrombus formation. In terms of specific mechanisms probed, changes in redox status (MDA and TEAC), neurological markers (TH and NeuroD1) and endothelial health (tight/adhesion junction protein expression) were assessed.

RESULTS:

Rooibos treatment limited thrombus formation and prevented stroke-induced deficits on larval motility. In terms of redox status, rooibos treatment prevented lipid peroxidation 3 days after initial stroke induction, reducing the need for significant upregulation of endogenous antioxidant mechanisms. Stroke-induced changes in neuronal (NeuroD1 and TH) protein expression were normalized in the presence of rooibos, suggesting a neuroprotective role. In terms of tight junction proteins, stroke-related decreases in ZO-1 expression were again prevented by rooibos treatment. In addition, rooibos treatment may beneficially modulate levels of claudin-5 and VE-cadherin, to indirectly limit stroke-associated vascular dysfunction.

CONCLUSIONS:

Taken together, activity data and physiological assessments suggest that unfermented rooibos may indeed have benefit in the context of stroke, via action at multiple targets. Thus, current data further our understanding of the mechanisms of actions of rooibos and warrant future research to confirm sufficient bioavailability of rooibos in target tissues, in mammalian systems.

31 Dec 2024·Hematology

Successful treatment of two cases with Philadelphia-chromosome positive acute lymphoblastic leukemia who relapsed after allogeneic stem cell transplantation and the treatments with novel immunotherapies and ponatinib

Article

Author: Noguchi, Yuma ; Sadato, Daichi ; Tanaka, Masatsugu ; Doki, Noriko ; Harada, Yuka ; Nakajima, Hideaki ; Tamai, Yotaro ; Najima, Yuho ; Tachibana, Takayoshi

The outcomes of relapsed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) resistant to new drugs such as tyrosine kinase inhibitors, inotuzumab ozogamicin (InO) and blinatumomab are dismal. We treated two cases of Ph+ALL resistant to these drugs that achieved long-term survival after treatment with chimeric antigen receptor (CAR)-T cell therapy or a second allogeneic hematopoietic stem cell transplantation (HCT) with a sequential conditioning regimen. Case 1: A 15-year-old boy was diagnosed with Ph+ALL. Despite the second HCT after the treatment of ponatinib and blinatumomab, hematological relapse occurred. InO was ineffective and he was transferred to a CAR-T center. After the CAR-T cell therapy, negative measurable residual disease (MRD) was achieved and maintained for 38 months without maintenance therapy. Case 2: A 21-year-old man was diagnosed with Ph+ALL. Hematological relapse occurred after the first HCT. Despite of the treatment with InO, ponatinib, and blinatumomab, hematological remission was not achieved. The second HCT was performed using a sequential conditioning regimen with clofarabine. Negative MRD was subsequently achieved and maintained for 42 months without maintenance therapy. These strategies are suggestive and helpful to treat Ph+ALL resistant to multiple immunotherapies.

01 Dec 2024·BIOCHEMICAL PHARMACOLOGY

Ponatinib exacerbate renal injury in systemic lupus erythematosus mouse model through PDGFR-PI3K/AKT pathway

Article

Author: Ye, Wenling ; Qiao, Xiangyu ; Yan, Xiwei ; Jiang, Chengyu ; Chen, Gang ; Wang, Gangan ; Zheng, Ke ; Dong, Yixin ; Jia, Chunyu ; Li, Xuemei ; Ren, Pengju ; Deng, Xingyu

Lupus nephritis (LN) is a common clinical complication of systemic lupus erythematosus (SLE). Proliferative lupus nephritis represents the gravest form of LN, and since effective drugs for its treatment are still lacking, tyrosine kinase inhibitors (TKIs) find extensive clinical utility due to their notable impact on suppressing cell proliferation and may serve as potential drugs for LN treatment. However, previous studies on the effects of TKI on LN have been controversial. Ponatinib, a third-generation TKI, lacks studies on its role in LN. This study aimed to investigate the impact of the ponatinib on LN. MRL/lpr mice were evaluated for renal function, autoimmune markers and histopathological changes after oral administration of ponatinib. RNA-seq analysis was performed to explore the molecular pathways involved in ponatinib-induced kidney injury. Ponatinib uniquely exacerbated renal damage in MRL/lpr mice, evidenced by a decline in renal function and acute pathological changes, without affecting lupus-related autoimmune markers. Differential expressed genes analysis and functional enrichment implicate ponatinib-induced renal damage in MRL/lpr mice associated with adiponectin. Furthermore, we verified ponatinib signaling the PI3K/AKT pathway through PDGFRα, potentially influencing high molecular weight adiponectin (HMW ADIPOQ) expression and exacerbating renal damage. In conclusion, this study demonstrates that ponatinib can up-regulate HMW ADIPOQ expression via the PI3K/AKT pathway by inhibiting PDGFRα phosphorylation, highlighting the potential nephrotoxic effects of ponatinib in lupus-prone mice, and underscoring the importance of monitoring renal function in systemic autoimmune diseases patients receiving ponatinib.

News (Medical) associated with Ponatinib Hydrochloride

03 Dec 2024

·www.globenewswire.com

Terns Pharmaceuticals Announces Positive Early Data from Phase 1 CARDINAL Trial of TERN-701 for Chronic Myeloid Leukemia

Compelling molecular responses starting at lowest dose level in heavily pre-treated patients with high baseline BCR-ABL transcript levels Encouraging safety profile with no dose limiting toxicities, adverse event-related treatment discontinuations, or dose reductions across three dose escalation cohorts High levels of target coverage achieved with once daily dosing at all doses Completion of dose escalation and initiation of dose expansion expected in 1H25 Additional efficacy data expected in 4Q25, including longer term major molecular response (MMR) rates Company to host webcast at 8:00 am ET today FOSTER CITY, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced encouraging early data from the ongoing dose escalation part of the Phase 1 CARDINAL study evaluating TERN-701 in patients with relapsed/refractory chronic myeloid leukemia (CML). TERN-701 is an investigational, oral, potent, small molecule allosteric BCR-ABL inhibitor being developed for patients with CML. CARDINAL is a global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, pharmacokinetics (PK), and efficacy of TERN-701 in patients with relapsed/refractory CML with or without BCR-ABL resistance mutations who were previously treated with at least one 2G tyrosine kinase inhibitor (TKI). Patients previously treated with asciminib are also eligible. “These exciting early data from our Phase 1 dose escalation cohorts clearly show TERN-701 has compelling clinical activity with a highly encouraging cumulative MMR rate of 50% at 3 months. At the first two dose levels, we see clinically meaningful molecular and hematologic responses in patients with high baseline BCR-ABL transcript levels who had poor responses on prior 2G TKIs, 3G TKIs including ponatinib, as well as asciminib,” said Emil Kuriakose MD, chief medical officer of Terns. “The emerging safety data show a profile supporting best-in-class potential with no dose limiting toxicities across three completed dose levels, no clinically meaningful changes in liver or pancreatic enzymes, and no AE-related dose reductions or discontinuations at doses that achieve plasma exposures well above target efficacious concentrations. Taken together, the clinical activity and safety data across the dose range in these heavily pre-treated patients with refractory disease support a potential wide therapeutic index that allows for high levels of target coverage with favorable safety/tolerability.” “We are thrilled to share these impactful early data from the Phase 1 CARDINAL study of TERN-701, which support its potential to be a best-in-class allosteric inhibitor for the treatment of CML,” said Amy Burroughs, chief executive officer of Terns. “In addition to the meaningful clinical data, the CARDINAL study highlights yet another example of excellent clinical and operational execution at Terns, with patients enrolled in all four dose escalation cohorts in less than a year. We are well-positioned to initiate dose expansion cohorts in the first half of 2025 and look forward to sharing additional safety and efficacy data, including longer term MMR data in late 2025.” As of the October 28, 2024 cutoff date, 15 patients were enrolled across three dose levels of 160mg (n=7), 320mg (n=5), and 400mg (n=3) of TERN-701 dosed once daily, with an overall median treatment duration of 3 months (range 0.79 - 7.5 months). Enrolled patients were heavily pretreated with a median of 4 prior TKIs (range: 1-6) and 80% having had 3 or more TKIs. 47% and 40% of patients, respectively, had previously received ponatinib and asciminib. 73% were not in MMR at baseline, with 60% having a baseline BCR-ABL transcript >1% international scale (IS). As of the data cutoff, 14 of 15 patients remain on treatment. Twelve patients were efficacy evaluable, defined as having baseline BCR-ABL transcript and at least two post-baseline BCR-ABL transcript levels (centrally assessed). All efficacy evaluable patients were in the 160mg and 320mg dose levels. Key efficacy highlights include: 88% (7/8) of patients with baseline transcript > 1% had decreases in BCR-ABL on treatment, with 7 ongoing as of data cutoffCumulative MMR rate of 50% (5/10) in non-T315i mutation patients with 3 or more months of treatment and/or MMR or better at baseline100% (4/4) of patients with MMR or better at baseline have maintained their response and remain on treatmentAdditional notable responses include: MR2 within 5 months in a 4L patient at 160mg QD with baseline transcript > 1% and suboptimal response and intolerance to asciminibMR4 (deep molecular response) within 3 months in a 5L patient treated at 320mg with baseline transcript >10% and treatment failure on bosutinib at study entry TERN-701 showed a highly encouraging safety profile across the 160mg to 400mg dose levels, with 500mg undergoing evaluation as of data cutoff. Key safety highlights: No dose limiting toxicities (DLT) through 400mg dose levelNo adverse event (AE)-related treatment discontinuations or dose reductionsNo Grade 3 or higher treatment-related AEsNo treatment related serious AEs The incidence of treatment emergent hematologic AEs was notably low in this heavily pre-treated population, with no Grade 3 or higher treatment-related cytopenias. There were no non-hematologic treatment-related AEs more than Grade 2 in severity. Finally, no clinically meaningful changes in liver and pancreatic enzymes, blood pressure and other vitals, or electrocardiogram were seen. Steady state PK data, available for the 160mg and 320mg dose levels at data cutoff, showed linear PK with dose proportional increases in exposure. Plasma protein binding-corrected Caverage for TERN-701 exceeded the in vitro IC90 for multiple mutated and non-mutated BCR-ABL variants with once daily dosing. Importantly, at 160mg and 320mg QD, TERN-701 achieved average free drug concentrations approximately 4-fold and 8-fold higher, respectively, than in vivo exposures where potent inhibition of the BCR-ABL signaling pathway in was seen in CML mouse tumor models, indicating robust pharmacodynamic effects at these clinical doses. As of December 3, 2024, the CARDINAL study has enrolled 19 patients inclusive of the 500mg cohort, with all dose escalation cohorts having enrolled at least 3 patients. The study is on track to initiate dose expansion in the first half of 2025 with additional efficacy data expected in the fourth quarter of 2025, including longer term MMR rates. Company WebcastTerns will host a company webcast at 8:00 am ET today. The discussion will cover TERN-701’s Phase 1 interim data, next steps for the CARDINAL program, and TERN-701’s potential role in the CML treatment landscape. The event will be webcast live and can be accessed by visiting the investor relations section of the Company’s website at https://ir.ternspharma.com. An archived webcast will be available following the event. About CARDINALThe CARDINAL trial is an ongoing global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, PK, and efficacy of TERN-701 in patients with previously treated CML. Part 1 is the dose escalation portion of the trial evaluating once-daily TERN-701 monotherapy in up to five dose cohorts in up to 60 adults with chronic phase CML with confirmed BCR-ABL and a history of treatment failure or suboptimal response to at least one second generation TKI (nilotinib, dasatinib or bosutinib). Participants who are intolerant to prior TKI treatment (including asciminib) are also allowed. The primary endpoints for Part 1 are the incidence of DLTs during the first treatment cycle, and additional measures of safety and tolerability. Secondary endpoints include TERN-701 PK and efficacy assessments, such as hematologic and molecular responses as measured by the change from baseline in BCR-ABL transcript levels. The starting dose is 160 mg QD (once-daily) with dose escalations as high as 500 mg QD and the option to explore a lower dose of 80 mg QD. Part 2 is the dose expansion portion of the trial that will enroll approximately 40 patients, randomized to once-daily treatment with one of two doses of TERN-701 to be selected based on data from Part 1. The primary endpoint of the dose expansion portion of the trial is efficacy, measured by hematologic and molecular responses. Secondary endpoints include safety, tolerability and PK. The overall objective of the CARDINAL trial is to select the optimal dose(s) of TERN-701 to move forward to a potential pivotal trial in chronic phase CML. About Terns PharmaceuticalsTerns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1 receptor agonist, a THR-β agonist, and a preclinical GIPR modulator discovery effort, prioritizing a GIPR antagonist nomination candidate. For more information, please visit: www.ternspharma.com. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to expectations, timing and potential results of the clinical trials and other development activities of the Company and its partners; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities, including the results of any interactions with regulatory authorities on its programs; the Company’s expectations regarding the profile of its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; the potential commercialization of the Company’s product candidates; the Company’s plans and expectations around the addition of key personnel; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Contacts for Terns InvestorsJustin Nginvestors@ternspharma.com MediaJenna UrbanBerry & Company Public Relationsmedia@ternspharma.com

Phase 1Clinical Result

25 Nov 2024

·www.businesswire.com

Incyte to Spotlight New Data, Including a Late Breaking Oral Presentation for Tafasitamab in Follicular Lymphoma, at the 2024 ASH Annual Meeting

WILMINGTON, Del.--( BUSINESS WIRE )--Incyte (Nasdaq: INCY) today announced that the Company will present new data from across its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego. “These data illustrate our innovative approach that aims to identify new and best-in-class treatments for patients with a range of cancers,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “At ASH, we’re presenting comprehensive data from our Phase 3 inMIND trial in relapsed or refractory follicular lymphoma. This late-breaking presentation provides valuable insights into the potential role of tafasitamab in improving outcomes for FL patients who currently face limited effective treatment options.” Details on key abstracts accepted for presentation include: ASH Abstracts Late-Breaking Oral Presentation Tafasitamab Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND) Session: Late-Breaking Abstracts Session. Publication Number: LBA-1. December 10, 10:30 a.m. ET (7:30 a.m. PT). Oral Presentations Axatilimab Dynamics of Overall and Organ-Specific Responses to Axatilimab in Chronic Graft-Versus-Host Disease: Analysis from the AGAVE-201 Study Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Predicting and Treating Acute and Chronic GVHD. Publication Number: 98. December 7, 12:45 p.m. ET (9:45 a.m. PT). INCB057643 Safety and Efficacy of Bromodomain and Extra-Terminal Inhibitor INCB057643 in Patients with Relapsed or Refractory Myelofibrosis and Other Advanced Myeloid Neoplasms: A Phase 1 Study Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Advancing Treatment Paradigms in Myeloproliferative Neoplasms and Mastocytosis. Publication Number: 658. December 8, 8:15 p.m. ET (5:15 p.m. PT). Poster Presentations Ruxolitinib (Myeloproliferative Neoplasms [MPN]) Clinical and Molecular Characterization of Disease Progression in Patients (Pts) with Low-Risk Myelofibrosis (MF) Enrolled in the MOST Study Poster Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. Publication Number: 3136. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Molecular Predictors of Disease Progression to Myelofibrosis (MF) in Patients (Pts) with Polycythemia Vera (PV) Enrolled in REVEAL Poster Session: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II. Publication Number: 3145. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Real-World Treatment Patterns and Blood Count Control in Patients with Polycythemia Vera Who Switched From Hydroxyurea to Ruxolitinib Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster II. Publication Number: 3813. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Clinical Outcomes in Patients with Myelofibrosis Treated with Ruxolitinib and Anemia-Supporting Medications Poster Session: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III. Publication Number: 4546. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Ruxolitinib (Graft-versus-host Disease [GVHD]) Real-World Ruxolitinib and Corticosteroid Treatment Patterns in Patients with Chronic Graft-Versus-Host Disease in the United States Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III. Publication Number: 4900. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Tafasitamab Real-World Effectiveness of Tafasitamab (Tafa) for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) in the United States Poster Session: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I. Publication Number: 2375. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Maintenance of CD19 Expression After Tafasitamab Treatment in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) From Clinical Trial and Real-World Settings Poster Session: 622. Lymphomas: Translational – Non-Genetic: Poster II. Publication Number: 2991. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Axatilimab Axatilimab Abrogates Inflammatory Cytokines and Chemokines and Interrupts the Differentiation of Monocytes to Macrophages, a Pathogenic Driver of Inflammation and Fibrosis in cGVHD Poster Session: 201. Granulocytes, Monocytes, and Macrophages: Poster I. Publication Number: 1147. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Exposure-Response Relationships for Axatilimab, a Humanized Monoclonal Antibody Targeting CSF-1R, in Patients with Chronic Graft-Versus-Host Disease Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I. Publication Number: 2140. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Real-World Patient Characteristics and Treatment Patterns in Patients with Chronic Graft-Versus-Host Disease Receiving Belumosudil in the United States Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II. Publication Number: 3522. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). Ponatinib The Impact of Ponatinib on Pregnancy Outcomes Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster I. Publication Number: 2435. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Long-Term Safety and Effectiveness of Ponatinib Treatment in Patients with TKI Intolerance: Subgroup Analysis of the Observational Study of Ponatinib Treatment in Patients with CML in Italy (OITI) Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster I. Publication Number: 2427. December 7, 8:30 p.m. – 10:30 p.m. ET (5:30 p.m. – 7:30 p.m. PT). Ponatinib Safety Profile: An Analysis of 10-Years of Real-World Experience Poster Session: 908. Outcomes Research: Myeloid Malignancies: Poster II. Publication Number: 3816. December 8, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). INCB057643 Machine Learning in Predicting Longitudinal Platelet Counts: Applications in Dose Optimization Poster Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster III. Publication Number: 4985. December 9, 9:00 p.m. – 11:00 p.m. ET. (6:00 p.m. – 8:00 p.m. PT). More information regarding the 2024 ASH Annual Meeting can be found on their website: https://www.hematology.org/meetings/annual-meeting/schedule-and-program . All sessions will be broadcast virtually, and access to the meeting’s virtual platform is included with registration. Conference Call and Webcast Incyte will hold a conference call and webcast on Thursday, December 12, 2024, from 4:00-5:00 p.m. ET, to discuss key data presentations at ASH, including data from the Phase 3 inMIND study presented during the late breaking session and its BET inhibitor program. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13750244. If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay, you will need the conference identification number, 13750244. The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for ninety days. About Jakafi ® (ruxolitinib) Jakafi ® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. Jakafi is a registered trademark of Incyte. About Monjuvi ® (tafasitamab-cxix) Monjuvi ® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb ® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). MorphoSys and Incyte entered into: (a) in January 2020, a collaboration and licensing agreement to develop and commercialize tafasitamab globally; and (b) in February 2024, an agreement whereby Incyte obtained exclusive rights to develop and commercialize tafasitamab globally. In the United States, Monjuvi ® (tafasitamab-cxix) received accelerated approval by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). In Europe, Minjuvi ® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). XmAb ® is a registered trademark of Xencor, Inc. Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the “triangle” design are registered trademarks of Incyte. About Zynyz ® (retifanlimab-dlwr) Zynyz ® (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. Zynyz is a registered trademark of Incyte. About Pemazyre ® (pemigatinib) Pemazyre ® (pemigatinib) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test*. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Pemazyre and the Pemazyre logo are registered trademarks of Incyte. * Pemazyre ® (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. About Niktimvo™ (axatilimab-csfr) Niktimvo™ (axatilimab-csfr) is a first-in-class anti-CSF-1R antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs). In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize Niktimvo from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for Niktimvo in cGVHD and any future indications. Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids are expected to initiate by year end. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256). Niktimvo is a trademark of Incyte. All other trademarks are the property of their respective owners. Niktimvo (axatilimab-csfr) is licensed from Syndax. About Iclusig ® (ponatinib) tablets Iclusig ® (ponatinib) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Click here to view the Iclusig EU Summary of Medicinal Product Characteristics. Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. About Incyte A global biopharmaceutical company on a mission to Solve On. , Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia. For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn , X , Instagram , Facebook , YouTube . Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential presented by that pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions and Incyte’s goal of improving the lives of patients, contain predictions, estimates, and other forward-looking statements. These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended September 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.

Phase 3Drug ApprovalLicense out/inASHClinical Result

22 Nov 2024

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Olverembatinib Surmounts Ponatinib and Asciminib Resistance and Is Well Tolerated in Patients With CML and Ph+ ALL: New Report in JAMA Oncology

ROCKVILLE, Md. and SUZHOU, China, Nov. 21, 2024 /PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, announced today that findings from a phase Ib multicenter clinical trial (NCT04260022) of its third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) have been published in the November 2024 issue of JAMA Oncology, marking a milestone in global awareness concerning the agent. JAMA Oncology is among the most influential and high-ranking oncology publications, with a 2023 impact factor of 28.4. It is read widely by the clinical-oncology community, with 6.4 million original downloads or views per annum. In 2023, the journal accepted only about 155 (7%) of 2,223 research-article submissions. Olverembatinib may help to address critical unmet clinical needs related to TKI treatment resistance and intolerance, which can impose formidable humanistic and economic burdens especially in heavily pretreated patients with suboptimal outcomes. For instance, arterial occlusive events (AOEs) constitute one salient and potentially dose-limiting treatment challenge with certain second- and third-generation TKIs. This study (NCT04260022) randomly allocated 80 patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph⁺ ALL) to receive oral olverembatinib 30, 40, or 50 mg on alternate days. The study population was heavily pretreated: approximately 18% of patients had received two prior TKIs, 28% three, and 54% at least four. Forty-six patients (57.5%) had received ponatinib; 25 (31.3%), asciminib; and 11 (13.8%), both medications.1 Among all evaluable patients with chronic-phase CML (CP-CML), the complete cytogenetic response (CCyR) rate was approximately 61% and the major molecular response (MMR) rate, approximately 42%. Cytogenetic and molecular responses were similar irrespective of the presence of the T315I mutation, which confers resistance against imatinib and all second-generation TKIs.1 Importantly, approximately 58% of patients with prior ponatinib treatment failure achieved CCyR and about 37%, MMR. Corresponding values in patients with asciminib treatment resistance were 50% and 33%.1 Olverembatinib was also well tolerated, with leading (typically mild or moderate) treatment-emergent adverse events including elevated blood creatine phosphokinase and thrombocytopenia. There were no fatal treatment-related adverse events. Treatment-related AOEs were infrequent (3%) and mild or moderate (grade 1 or 2); no such olverembatinib-related event was considered serious. "I am delighted to showcase the strength and progress of the 'lead' asset of Ascentage Pharma, which exemplifies the richness and diversity of our product pipeline of innovative, patient-centric therapies for a range of hematologic malignancies," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "In the future, we will continue to advance these development programs in efforts to bring more treatment options to patients with unmet clinical needs around the world." "One potential explanation for the response of olverembatinib in patients with ponatinib and asciminib resistance is its broad (pan-BCR::ABL1-kinase domain) mutational coverage," said principal investigator Elias Jabbour, MD, Professor of Leukemia at The University of Texas MD Anderson Cancer Center. "In studies to date, olverembatinib has shown greater sensitivity and clinical benefit against compound mutations – two or more mutations within the same allele of BCR::ABL1 – compared with other approved TKIs and the STAMP inhibitor asciminib." Findings from this trial have also been presented at leading hematologic-oncology congresses around the world, including the 29th European Hematology Association Congress, which convened June 13-16, 2024, in Madrid; the 12th annual meeting of the Society of Hematologic Oncology, on September 4-7, 2024, in Houston, Texas; and the ESH-iCMLf 26th Annual John Goldman Conference on Chronic Myeloid Leukemia (Biology and Therapy), on September 27-29, 2024, in Prague. Updated results will be presented at the 66th American Society of Hematology Annual Meeting and Exposition, December 8, 2024 (6:00-8:00 PM), in San Diego, CA (poster/publication #3151). "Publication of our trial results in JAMA Oncology represents a major milestone for olverembatinib, and the study established the recommended dose for our ongoing phase III registrational trial: POLARIS-2 [NCT06423911]," said Dr. Dajun Yang, Chairman & CEO of Ascentage. "We look forward to that trial and, in the future through our option agreement with Takeda, to potentially bring this medication to underserved populations around the world, including patients with CML or Ph⁺ ALL that is resistant to or intolerant of other medications." On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda () for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China. Olverembatinib is currently approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase CP-CML or accelerated-phase CML harboring the T315I mutation as confirmed by a validated diagnostic test. It is also approved for adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. It remains investigational in other parts of the world. Reference 1. Jabbour E, Oehler VG, Koller PB, et al. Olverembatinib after failure of tyrosine kinase inhibitors, including ponatinib or asciminib: a phase 1b randomized clinical trial. JAMA Oncol 2024. doi:10.1001/jamaoncol.2024.5157 About Ascentage Pharma Ascentage Pharma (6855.HK) is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in malignancies. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. The company has built a rich pipeline of innovative drug candidates that includes novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation TKIs. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company has conducted more than 40 clinical trials in the US, Australia, Europe, and China, including 13 registrational studies (completed/ ongoing/planned). Olverembatinib, the company's first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company's first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company's investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients. Forward-Looking Statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions and expectations or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions and expectations may alter in light of future development. SOURCE Ascentage Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultASHPhase 3Fast TrackOrphan Drug

100 Deals associated with Ponatinib Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D09951	Ponatinib Hydrochloride	L01XE24	DB08901

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Myelogenous Leukemia	AU	Takeda Pharmaceuticals Australia Pty Ltd.	26 Nov 2014
Aggressive-Phase Chronic Myelocytic Leukemia	EU	Incyte Biosciences Distribution BV	01 Jul 2013
Aggressive-Phase Chronic Myelocytic Leukemia	IS	Incyte Biosciences Distribution BV	01 Jul 2013
Aggressive-Phase Chronic Myelocytic Leukemia	LI	Incyte Biosciences Distribution BV	01 Jul 2013
Aggressive-Phase Chronic Myelocytic Leukemia	NO	Incyte Biosciences Distribution BV	01 Jul 2013
Blast Phase Chronic Granulocytic Leukemia	EU	Incyte Biosciences Distribution BV	01 Jul 2013
Blast Phase Chronic Granulocytic Leukemia	IS	Incyte Biosciences Distribution BV	01 Jul 2013
Blast Phase Chronic Granulocytic Leukemia	LI	Incyte Biosciences Distribution BV	01 Jul 2013
Blast Phase Chronic Granulocytic Leukemia	NO	Incyte Biosciences Distribution BV	01 Jul 2013
Chronic phase chronic myeloid leukemia	EU	Incyte Biosciences Distribution BV	01 Jul 2013
Chronic phase chronic myeloid leukemia	IS	Incyte Biosciences Distribution BV	01 Jul 2013
Chronic phase chronic myeloid leukemia	LI	Incyte Biosciences Distribution BV	01 Jul 2013
Chronic phase chronic myeloid leukemia	NO	Incyte Biosciences Distribution BV	01 Jul 2013
Philadelphia positive acute lymphocytic leukaemia	EU	Incyte Biosciences Distribution BV	01 Jul 2013
Philadelphia positive acute lymphocytic leukaemia	IS	Incyte Biosciences Distribution BV	01 Jul 2013
Philadelphia positive acute lymphocytic leukaemia	LI	Incyte Biosciences Distribution BV	01 Jul 2013
Philadelphia positive acute lymphocytic leukaemia	NO	Incyte Biosciences Distribution BV	01 Jul 2013
Acute Lymphoblastic Leukemia	US	Takeda Pharmaceuticals U.S.A., Inc.	14 Dec 2012
Philadelphia chromosome positive chronic myelogenous leukemia	US	Takeda Pharmaceuticals U.S.A., Inc.	14 Dec 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Philadelphia Chromosome Positive Leukemia	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	CN	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	AR	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	AU	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	BR	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	CZ	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	FR	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	IT	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	MX	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021
Philadelphia Chromosome Positive Leukemia	Phase 2	NL	Takeda Pharmaceutical Co., Ltd.	24 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Philadelphia chromosome positive chronic myelogenous leukemia	-	Ponatinib-based therapy	jfllqldnod(dyofamhuqn) = cmvmommymz ylfgpciywr (ousfsgxujs ) View more	-	08 Dec 2024
				Intensive chemotherapy (IC)	fwtxbazdat(fyptkcylqp) = eyvrbuzjjy vopgxeebal (njupxveimp )
ASH2024	Not Applicable	Philadelphia positive acute lymphocytic leukaemia	-	Ponatinib	lzzjcrxnga(oefwokpufq) = Vascular occlusive events (peripheral arterial occlusive disease and venous thrombosis; both grade 2) occurred in 2/34 pts receiving ponatinib monotherapy; both events resolved following dose reduction or interruption. omdxoixelx (inrqgnpiht )	-	08 Dec 2024
				Imatinib
ASH2024	Not Applicable	Philadelphia positive acute lymphocytic leukaemia	-	Ponatinib	okwddnxaqr(rwmumjjzzt) = rjglounknd fvydikrczx (rmpgphgbdj ) View more	-	08 Dec 2024
				Imatinib	okwddnxaqr(rwmumjjzzt) = xqdbynhrwl fvydikrczx (rmpgphgbdj )
NCT04070443 (TIPI, ASH2024)	Phase 2	Philadelphia chromosome positive chronic myelogenous leukemia	-	Ponatinib 30 mg QD	uddgwnyfim(ndfgwacpox) = 2 hematologic (grade 4 neutropenia at M6) beegmdypuh (wbptodipbd )	Positive	08 Dec 2024
				Imatinib 400 mg QD
ASH2024	Not Applicable	Philadelphia chromosome positive chronic myelogenous leukemia	-	Ponatinib 45 mg	usuipceeto(kofzznslke) = Thirty-one pts had ≥1 PON-related AE, most commonly hypertension (n=4), increased lipase, increased alanine aminotransferase, and increased aspartate aminotransferase (n=2 each). Six pts had CV events, including 1 arterial occlusion event. zrzanzqdaw (geumatxnvv )	-	07 Dec 2024
				Ponatinib 30 mg
NCT02467270 (OPTIC, SOHO2024)	Phase 2	Chronic phase chronic myeloid leukemia T315I mutation	283	Ponatinib 45 mg	mpcgvopfis(otfhjlniio) = jpivznfvwr ttveilcjaf (wpkybnwkjq, 42.5–82.0) View more	Positive	04 Sep 2024
				Ponatinib 30 mg	mpcgvopfis(otfhjlniio) = zipultzrkb ttveilcjaf (wpkybnwkjq, 8.7–49.1) View more
SOHO2024	Not Applicable	Philadelphia positive acute lymphocytic leukaemia	-	Ponatinib	yqqxvkldlc(wrvquiadjg) = fqctoeykzq nfvntionyb (yrbkayxpsu ) View more	-	04 Sep 2024
				Imatinib	yqqxvkldlc(wrvquiadjg) = nfxuegcjkd nfvntionyb (yrbkayxpsu ) View more
NCT02467270 (OPTIC, SOHO2024)	Phase 2	Philadelphia chromosome positive chronic myelogenous leukemia	283	Ponatinib 45 mg	fzmvhbkhoz(xafwwhuubx) = ufcoolumtf pjffqrildk (wkpmntuzuw, 78.6–92.9) View more	Positive	04 Sep 2024
				Ponatinib 30 mg	fzmvhbkhoz(xafwwhuubx) = sceojmcoxl pjffqrildk (wkpmntuzuw, 76.4–91.7) View more
NCT04188405 (Pubmed \| Lancet Haematol) Manual	Phase 2	Chronic phase chronic myeloid leukemia \| Philadelphia Chromosome Positive Acute Myeloid Leukemia	20	Decitabine, venetoclax, and ponatinib	dxyfwuqhkt(ovpywyxmdh) = lbumeuucrv fpvjpjnclh (acpdrjuhpt ) View more	Positive	01 Sep 2024
NCT03263572 (Pubmed) Manual	Phase 2	Philadelphia positive acute lymphocytic leukaemia	60	Ponatinib and Blinatumomab	kheciggpoc(kiqvecddys) = brqbgxamlk xsiyndpcoc (qlxshowbub ) View more	Positive	19 Jul 2024

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