Daunorubicin Plus Cytarabine 3+5 Regimen Combined with Venetoclax in De Novo Patients with Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study

This study is a non-profit, prospective, single-center, open-label, controlled clinical trial aimed at evaluating the efficacy of the daunorubicin, cytarabine, and venetoclax (DAV) regimen in previously untreated adult AML patients eligible for intensive chemotherapy.The combination of daunorubicin administered for 3 consecutive days and cytarabine for 7 consecutive days constitutes the classic "3+7" induction chemotherapy regimen for AML patients eligible for chemotherapy. The addition of venetoclax to the "3+7" regimen has shown promising efficacy in newly diagnosed AML patients suitable for intensive therapy. However, this approach is associated with increased adverse reactions. Based on current clinical studies, we propose a modified approach involving reduced-dose chemotherapy combined with venetoclax for AML treatment, aiming to achieve optimal efficacy while effectively reducing adverse reactions.

Start Date01 Feb 2025

Sponsor / Collaborator

Anhui Medical University

[+1]

NCT06289673

/ RecruitingPhase 4IIT

INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.
Primary Objectives
* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
* To develop a central database of genomic and clinical findings.
Secondary Objectives
* To assess event free and overall survival data of patients enrolled on this study.

Start Date26 Dec 2024

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

NCT06313437

/ RecruitingPhase 1IIT

A Phase I Trial of Revumenib in Combination With 7+3 (7 Days of Cytarabine and 3 Days of Daunorubicin) + Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AML

This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).
The names of the study drugs involved in this study are:
* Revumenib (SNDX-5613) (a type of menin inhibitor)
* Midostaurin (a type of multi-kinase including FLT3 inhibitor)
* Cytarabine (a type of antineoplastic agent)
* Daunorubicin (a type of antineoplastic agent)

Start Date06 Dec 2024

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with Acetyladriamycin

100 Translational Medicine associated with Acetyladriamycin

100 Patents (Medical) associated with Acetyladriamycin

9,411

Literatures (Medical) associated with Acetyladriamycin

01 Mar 2025·PEDIATRIC BLOOD & CANCER

Treatment of a Pediatric Patient with Core Binding Factor Acute Myeloid Leukemia Post‐Cytotoxic Therapy With Cytarabine, Daunorubicin, and Gemtuzumab Followed by Stem Cell Transplantation

Letter

Author: Cuglievan, Branko ; Okeleji, Olayinka ; Quesada, Andres ; Khazal, Sajad ; Herzog, Cynthia E. ; Tewari, Priti ; Petropoulos, Demetrios ; Roth, Michael ; Uwaezuoke, Destiny ; Ragoonanan, Dristhi ; McCall, David ; Nunez, Cesar ; Sheikh, Irtiza N.

01 Mar 2025·BIOMEDICAL MICRODEVICES

Retraction Note: Label-free microfluidic chip for segregation and recovery of circulating leukemia cells: clinical applications in acute myeloid leukemia

Author: Chao, Shuen ; Li, Yonghua ; Hu, Lina ; Wang, Yiyang ; Tang, Bin ; Yarmush, Martin ; Ye, Ningxin ; Jiang, Yue ; Tuner, Memet ; Ouyang, Dongfang

We present a label-free microfluidic chip for the segregation of circulating leukemia cells (CLCs) from blood samples, with a focus on its clin. applications in Acute Myeloid Leukemia (AML).The microfluidic chip achieved an approx. capture efficiency of 92%.The study analyzed a comprehensive set of 66 blood specimens from AML patients in different disease stages, including newly diagnosed and relapsing cases, patients in complete remission, and those in partial remission.The results showed a significant difference in CLC counts between active disease stages and remission stages (p < 0.0001), with a proposed threshold of 5 CLCs to differentiate between the two.The microfluidic chip exhibited a sensitivity of 95.4% and specificity of 100% in predicting disease recurrence.Addnl., the captured CLCs were subjected to downstream mol. anal. using droplet digital PCR, allowing for the identification of genetic mutations associated with AML.Comparative anal. with bone marrow aspirate processing by FACS demonstrated the reliability and accuracy of the microfluidic chip in tracking disease burden, with highly agreement results obtained between the two methods.The non-invasive nature of the microfluidic chip and its ability to provide real-time insights into disease progression make it a promising tool for the proactive monitoring and personalized patient care of AML.

01 Feb 2025·Drug Metabolism and Pharmacokinetics

Population pharmacokinetic and exposure-response analysis to support a dosing regimen of CPX-351 (NS-87) in Japanese adult and pediatric patients with untreated high-risk acute myeloid leukemia

Article

Author: Marier, J F ; Hasegawa, Mayumi ; Ichikawa, Tomohiko ; Kusano, Kazutomi ; Imai, Shunji ; Akagi, Michiyo ; Kitada, Ayane ; Wang, Qi ; Ogura, Aya ; Vasilinin, Grygoriy

CPX-351 (NS-87; Vyxeos®) has a characteristic liposomal formulation and contains cytarabine and daunorubicin at a 5:1 molar ratio, which demonstrates synergistic activity in both in vitro and in vivo animal models. It has been approved in several countries for the treatment of newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Since there are very few Asian patients, especially Japanese adult and pediatric patients, only a small clinical study has been conducted in Japanese adult patients and no study in Japanese pediatric patients. Therefore, we need to continue collecting data to ensure efficacy, especially in Japan. The objectives of this study were to evaluate the exposure and efficacy of CPX-351 in adult and pediatric Japanese patients. For these purposes, population pharmacokinetic and exposure-response analysis was conducted based on the established model/analysis using non-Japanese data by incorporating the newly obtained results of a Japanese clinical trial. No significant differences in pharmacokinetic exposure and efficacy were observed between non-Japanese adult patients and Japanese adult or pediatric patients. This information supports CPX-351 as a treatment option for untreated Japanese t-AML/AML-MRC patients on the basis of efficacy and safety when referred to the evidence from non-Japanese subjects.

News (Medical) associated with Acetyladriamycin

09 Dec 2024

·endpts.com

Kura Oncology details 'aggressive' approach in first-line AML

SAN DIEGO — As Kura Oncology awaits key pivotal data in relapsed or refractory acute myeloid leukemia, the company is going all in on combinations in the frontline setting. On Monday, Kura and its partner Kyowa Kirin announced positive early responses from a Phase 1 trial of their oral menin inhibitor ziftomenib and said the data support the decision to start a Phase 3 trial evaluating first-line ziftomenib in combination with current standards of care. If the drug wins approval, CEO Troy Wilson said it could potentially reach $3 billion in peak US sales, a majority of which would likely come from the first-line setting. “One of the advantages of ziftomenib relative to the other drugs is its safety and tolerability in combinations is quite good,” Wilson said. “That’s why you see us moving so aggressively.” The data were presented at this year’s American Society of Hematology annual meeting. The partners said they didn’t observe any dose-limiting toxicities in the Phase 1a dose escalation portion of the KOMET-007 trial, nor any evidence of additive myelosuppression (a decrease in bone marrow activity) or ziftomenib-related QTc prolongation (a type of irregular heart rhythm). The latter condition is in the warning label for Syndax Pharmaceuticals’ recently approved rival menin inhibitor Revuforj. “These updated data overall continue to support ziftomenib’s best-in-class potential within the menin class,” Leerink analysts said in a note to investors on Monday. Mizuho analysts said the data are promising, but noted that it’s “still early days.” Kura also reported early signs of efficacy. Among 46 evaluable patients who received first-line ziftomenib alongside the chemotherapy regimen cytarabine and daunorubicin, 91% achieved a complete remission, Kura said. That includes all patients with a form of AML caused by a common mutation in the NPM1 gene and 83% of patients with a different genetic alteration called KMT2A rearrangement. While KMT2A is a less common genetic alteration, those patients tend to have worse prognoses. In relapsed or refractory AML patients who received ziftomenib in combination with the standard-of-care regimen venetoclax and azacitidine, 68% of NPM1 patients responded to treatment, as well as 30% of KMT2A patients. The Phase 1b expansion portion of the KOMET-007 study is currently enrolling at a 600 mg dose in all cohorts. “It’ll be interesting, for example, to take this data set and then look another six months on or another 12 months on,” Wilson said. “That will help educate us, and it will also help us to de-risk the Phase 3s.” In mid-2025, Wilson expects to launch the Phase 3 KOMET-017 trial, which will evaluate ziftomenib in newly diagnosed patients in combination with venetoclax and azacitidine as well as with cytarabine and daunorubicin. In early 2025, the partners also plan to read out pivotal results for ziftomenib as a monotherapy in NPM1-mutated AML. Syndax recently announced that its own pivotal trial NPM1 patients met the primary endpoint, and the company is planning to file for US approval in the first half of next year.

Clinical ResultPhase 3Phase 1ASCOASH

09 Dec 2024

·www.globenewswire.com

Kura Oncology and Kyowa Kirin Report Positive Combination Data for Ziftomenib at American Society of Hematology Annual Meeting

– Interim analysis from Phase 1a portion of KOMET-007 shows 100% CR rate in NPM1-m and 83% CR rate in KMT2A-r 1L adverse risk AML with 7+3 – – 100% of 1L NPM1-m and 96% of 1L KMT2A-r AML patients alive as of data cutoff with median follow-up of 31 and 19 weeks, respectively – – Promising clinical activity in R/R NPM1-m and KMT2A-r AML with ven/aza, including ven-experienced patients – – Ziftomenib generally well tolerated in combination with standards of care at all dose levels studied – – Kura Oncology to host virtual investor event today at 8:00 a.m. ET – SAN DIEGO and TOKYO, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) provided encouraging clinical data from KOMET-007, a Phase 1 dose-escalation trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care, including cytarabine/daunorubicin (7+3) and venetoclax/azacitidine (ven/aza), in patients with NPM1-mutant (NPM1-m) and KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). These data were presented at the 2024 American Society of Hematology (ASH) Annual Meeting. An oral presentation highlighting ziftomenib combined with 7+3 in newly diagnosed (1L) NPM1-m and KMT2A-r adverse riski AML, and a poster featuring ziftomenib in combination with ven/aza in relapsed/refractory (R/R) NPM1-m and KMT2A-r AML are available in the Posters and Presentations section on Kura’s website. Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the study. No dose-limiting toxicities, evidence of ziftomenib-associated QTc prolongation, drug-drug interactions or additive myelosuppression were observed. In the 7+3 combination cohorts, on-target differentiation syndrome (DS) occurred in 2% (1/51) of patients. Grade ≥3 treatment emergent adverse events occurring in ≥20% were febrile neutropenia platelet count decreased, anemia and neutropenia count decrease and white blood cell count decreased. In the ven/aza combination cohorts, on-target DS occurred in 8% (4/53) of patients. Grade ≥3 treatment emergent adverse events occurring in ≥20% were platelet count decreased, anemia and febrile neutropenia. All instances of DS were manageable, and no patients discontinued participation due to DS. The Phase 1b expansion portion of KOMET-007 is now enrolling at 600 mg in all cohorts, including patients with 1L NPM1-m or KMT2A-r AML in combination with ven/aza. Among the response-evaluable patients enrolled in the 7+3 combination cohort for patients with 1L NPM1-m or KMT2A-r adverse riski AML, 91% (42/46) achieved a complete remission (CR) (100% for NPM1-m, 83% for KMT2A-r patients). MRD negativity was 76% in NPM1-m and 75% in KMT2A-r patients. All NPM1-m patients (24/24) and 96% (26/27) of KMT2A-r patients remained alive as of the data cutoff on October 1, 2024, with a median follow-up of 31 and 19 weeks, respectively. A total of 54 patients were enrolled in the combination cohort with ven/aza in R/R NPM1-m or KMT2A-r AML. The NPM1-m population achieved an overall response rate (ORR) of 68% (15/22) and a composite complete remission (CRc) rate of 50% (11/22). In NPM1-m patients with previous ven exposure, ORR was 50% (7/14) and CRc was 36% (5/14). In KMT2A-r patients, 30% of patients responded, including those with prior ven exposure. “The findings presented at ASH underscore the potential of ziftomenib in combination with standards of care as an early intervention in the frontline setting of AML and could offer a meaningful opportunity to improve patient outcomes,” said Amer Zeidan, MBBS, MHS, chief of the Division of Hematologic Malignancies, director of Hematology Early Therapeutics Research at Yale Cancer Center, and lead investigator of the KOMET-007 trial. “The high rates of complete remission and MRD negativity across the 7+3 cohorts are particularly encouraging. The rapid enrollment in the Phase 1a portion of this study underscores the urgency and enthusiasm for further evaluating this combination approach.” Kura and Kyowa Kirin recently announced plans for KOMET-017, a global, pivotal Phase 3 study evaluating ziftomenib in combination with standards of care for adults with newly diagnosed KMT2A-r or NPM1-m AML. The trial includes two independently powered, randomized, double-blind, placebo-controlled studies: a non-intensive therapy arm testing ziftomenib with ven/aza, and an intensive therapy arm testing ziftomenib with 7+3. The positive results from KOMET-007 reported at ASH reinforce Kura’s and Kyowa Kirin’s commitment to evaluating ziftomenib for patients across the continuum of frontline treatment options. The KOMET-017 study is expected to initiate in mid-2025. “Starting patients on therapy early is essential to improving outcomes in AML,” said Mollie Leoni, M.D., Executive Vice President, Clinical Development at Kura Oncology. “The updated KOMET-007 data underscore the combination potential of ziftomenib in the frontline setting, strengthening our confidence in its ability to provide a valuable treatment option for a significant portion of the AML population. Together, the KOMET-007 Phase 1b trial and the KOMET-017 pivotal Phase 3 study will allow us to further explore this approach and the potential to transform care if approved for AML patients worldwide.” “More than half of AML patients with an NPM1 mutation will relapse with poor survival outcomesii, making it a significant area of unmet medical need in the frontline setting,” said Takeyoshi Yamashita, Ph.D., Senior Managing Executive Officer and Chief Medical Officer of Kyowa Kirin. “The data observed to date represent the potential of ziftomenib to help address the treatment gap and improve upon current standards of care. Leveraging our hemato-oncology expertise and commitment to patients, we are committed to rapidly advancing the clinical development of ziftomenib.” Virtual Investor Event Kura will host a webcast and conference call featuring Kura Oncology management and Key Opinion Leaders Amir T. Fathi, MD, Associate Professor of Medicine at Harvard Medical School and Director of the Leukemia Program at Massachusetts General Cancer Center, and Amer Zeidan, MBBS, MHS, interim chief of the Division of Hematologic Malignancies, Director of Hematology Early Therapeutics Research at Yale Cancer Center. The live call may be accessed by dialing (800) 715-9871 for domestic callers and (646) 307-1963 for international callers and entering the conference ID: 4326549. A live webcast will be available here and in the Investors section of Kura’s website, with an archived replay available shortly after the event. About Ziftomenib Ziftomenib is a selective and oral menin inhibitor currently in development for the treatment of genetically defined AML patients with high unmet need. In April 2024, ziftomenib received Breakthrough Therapy Designation (BTD) by the FDA for the treatment of R/R NPM1-mutant AML based on data from Kura’s ongoing KOMET-001 clinical trial. Additional information about clinical trials for ziftomenib can be found at kuraoncology.com/clinical-trials/#ziftomenib. About Kura Oncology Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib is being investigated as a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received BTD for the treatment of R/R NPM1-mutant AML. Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Kura is evaluating KO-2806, a next-generation farnesyl transferase inhibitor (FTI), in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato-oncology and rare diseases. A shared commitment to Kyowa Kirin’s values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com. Kura Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the pursuit of a broad ziftomenib development program including frontline indications and combinations with targeted therapies; the efficacy, safety and therapeutic potential of ziftomenib; potential benefits of combining ziftomenib with appropriate standards of care, including chemotherapies; and progress and expected timing of the ziftomenib program and clinical trials, including the timing of initiation of the pivotal Phase 3 frontline study. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, the risks associated with reliance on outside financing to meet capital requirements, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission (SEC), including the Company’s Form 10-Q for the quarter ended September 30, 2024 filed with the SEC on November 7, 2024, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Amer Zeidan has consulted and received honoraria from Kura. Opinions expressed are his own and do not necessarily represent those of his employer. Kura Contacts Investors:Pete De SpainExecutive Vice President, Investor Relations &Corporate Communications(858) 500-8833pete@kuraoncology.com Media:Cassidy McClainVice PresidentInizio Evoke Comms(619) 849-6009cassidy.mcclain@inizioevoke.com Kyowa Kirin Contacts Wataru SuzukiCorporate Communications Department – Globalmedia@kyowakirin.com Lauren WalrathVice President, Public Affairs – North Americalauren.walrath.g4@kyowakirin.com i Age ≥ 60 years and/or treatment-related AML and/or adverse risk cytogenetics per European LeukemiaNet (ELN)ii Prata PH, Bally C, Prebet T, et al. NPM1 mutation is not associated with prolonged complete remission in acute myeloid leukemia patients treated with hypomethylating agents. Haematologica. 2018;103(10):e455-e457.

Clinical ResultPhase 1Phase 2Phase 3Breakthrough Therapy

03 Dec 2024

·investor.jazzpharma.com

Jazz Pharmaceuticals to Present Advancements in Solid Tumors and Blood Cancer Research at San Antonio Breast Cancer Symposium and American Society of Hematology Annual Meeting

Data showcased at SABCS and ASH reflect progress and growth of Jazz's research and development in oncology and demonstrate ongoing efforts to redefine what is possible for cancer treatment DUBLIN , Dec. 3, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company and its partners will present two abstracts at the 2024 San Antonio Breast Cancer Symposium (SABCS) from December 10-13 and 13 abstracts at the 66th Annual American Society of Hematology (ASH) Annual Meeting from December 7-10. A trial-in-progress poster presentation at SABCS outlines the trial design of the ongoing Phase 3 EmpowHER-303 trial (NCT06435429), which is evaluating the efficacy and safety of Ziihera® (zanidatamab-hrii) vs trastuzumab with chemotherapy in patients with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, trastuzumab deruxtecan. New data from a Phase 1b/2 study of zanidatamab plus evorpacept (NCT05027139) in patients with pre-treated HER2-positive and HER2-low metastatic breast cancer will be featured as a poster spotlight. "Following the recent FDA approval of Ziihera for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, we are pleased to present meaningful data at SABCS on the positive impact zanidatamab can have for patients with HER2-expressing cancers. We continue to advance our clinical program for zanidatamab with the goal to improve outcomes for patients with difficult-to-treat HER2-positive cancers. Our development program includes multiple ongoing Phase 3 trials evaluating 1L BTC, 1L GEA, with top-line PFS results expected in the second quarter of 2025, and metastatic breast cancer after T-DXd treatment, supporting the use of zanidatamab after other HER2-targeted therapies," said Rob Iannone , M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals . "Additionally, we look forward to highlighting 13 abstracts featuring oncology research at ASH 2024, which underscores our commitment to improving standards of care in blood cancer and other hematologic diseases." The full SABCS abstracts are available here. The Jazz and partner-supported presentations at SABCS 2024 are: Ziihera® (zanidatamab-hrii) Presentations Topic Author Presentation Details EmpowHER 303: A phase 3 study to evaluate the efficacy and safety of zanidatamab vs trastuzumab withchemotherapy in patients (pts) with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, trastuzumab deruxtecan Sara M Tolaney, et al. Presentation Type: Poster Session Abstract Number: SESS-1922 Date: Friday December 13, 2024 Time: 12:00-2:00 PM (PST) Zanidatamab in combination with evorpacept in HER2-positive and HER2-low metastatic breast cancer: Results from a phase 1b/2 study Alberto J Montero, et al. Presentation Type: Poster Spotlight Presentation Abstract Number: SESS-2007 Date: Thursday December 12, 2024 Time: 7:00-8:30 AM (PST) The full ASH abstracts are available here. The Jazz and partner-supported presentations at ASH 2024 are: Vyxeos® (daunorubicin and cytarabine) Presentations Topic Author Presentation Details A Randomized Comparison of CPX-351 and FLAG-Ida in Patients WithHigh-Risk Acute Myeloid Leukemia(AML)/Myelodysplastic Syndrome (MDS) And MDS-Related GeneMutations: A Subgroup Analysis of the UK NCRI AML19 Trial Priyanka Mehta , et al. Presentation Type: Oral Presentation Abstract Number: #55 Date: Saturday December 7, 2024 Time: 9:30 AM (PST) AML-MR Mutations Drive the Benefit of CPX-351 over 7+3 in the Pivotal Phase 3 AML Trial Shai O Shimony, et al. Presentation Type: Oral Presentation Abstract Number: #60 Date: Saturday December 7, 2024 Time: 10:45 AM (PST) Phase Ib/II Study of CPX-351 in Combination with Venetoclax in Patients with Newly Diagnosed, HighRisk Acute Myeloid Leukemia Emmanuel Almanza , et al. Presentation Type: Poster Presentation Abstract Number: #1511 Date: Saturday December 7, 2024 Time: 5:30-7:30 PM (PST) A Randomised Comparison of CPX-351 versus Standard Daunorubicin and Cytarabine plus FractionatedGemtuzumab Ozogamicin in Older AML Adults Without Known AdverseRisk Cytogenetics: Results of the NCRIAML18 Trial Steven Knapper , et al. Presentation Type: Oral Presentation Abstract Number: #59 Date: Saturday December 7, 2024 Time: 10:30 AM (PST) Phase 1/1b Dose Escalation and Expansion of CPX-351 in Combinationwith Gemtuzumab Ozogamicin in Newly Diagnosed Acute MyeloidLeukemia Onyee Chan , et al. Presentation Type: Poster Presentation Abstract Number: #4270 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy IncludingGemtuzumab Ozogamicin (GO) to CPX-351 with GO – A report from the Children's Oncology Group Jessica A Pollard, et al. Presentation Type: Oral Presentation Abstract Number: #967 Date: Monday December 9, 2024 Time: 4:30 PM (PST) Combination of CPX-351 andGemtuzumab Ozogamicin (GO) inRelapsed Refractory (R/R) AcuteMyeloid Leukemia and PostHypomethylating Agent (HMA) FailureHigh-Risk Myelodysplastic Syndrome (HR-MDS) Jayastu Senapati , et al. Presentation Type: Poster Presentation Abstract Number: #2903 Date: Sunday December 8, 2024 Time: 6:00-8:00 PM (PST) Phase Ib/II Study of CPX-351 plusVenetoclax in Patients with Relapsed/Refractory Acute MyeloidLeukemia (AML) Vanthana Bharathi , et al. Presentation Type: Poster Presentation Abstract Number: #4272 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) Rapid, Reliable, and ComprehensiveIdentification of MDS-DefiningCytogenetic Changes By a FISH-Panel Containing Six Probes in a Real-World Population of Patients with Suspected AML Katayoon Shirneshan, et al. Presentation Type: Poster Presentation Abstract Number: #4308 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) Prospective Evaluation of the Impact ofMeasurable Residual Disease (MRD) by Error Corrected Next-GenerationSequencing (NGS) with CPX-351 inAcute Myeloid Leukemia (AML) David Sallman , et al. Presentation Type: Poster Presentation Abstract Number: #4332 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) A Phase 1 Study of CPX-351 Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia Onyee Chan , et al. Presentation Type: Poster Presentation Abstract Number: #1520 Date: Saturday December 7, 2024 Time: 5:30-7:30 PM (PST) Defitelio® (defibrotide sodium) Presentations Topic Author Presentation Details Genetic Susceptibility in Sinusoidal Obstruction Syndrome/Veno-OcclusiveDisease Ioulia Mavrikou, et al. Presentation Type: Poster presentation Abstract Number: #4778 Date: Monday December 9, 2024 Time: 6:00-8:00 PM (PST) Defibrotide reduces hypercoagulablestate in patients with Sickle Cell Disease-Related Acute ChestSyndrome Edo Schaefer , et al. Presentation Type: Poster presentation Abstract Number: #2515 Date: Sunday December 8, 2024 Time: 6:00-8:00 PM (PST) About Ziihera® (zanidatamab-hrii) Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity ( CDC ), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States , Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication 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).1 Zanidatamab is not approved anywhere else in the world. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule. The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Important Safety Information for ZIIHERA® WARNING: EMBRYO-FETAL TOXICITY Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patientsof the risk and need for effective contraception. WARNINGS AND PRECAUTIONS Embryo-Fetal ToxicityZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA. Left Ventricular DysfunctionZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients. Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions. The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%. Infusion-Related ReactionsZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day. Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use. If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs. DiarrheaZIIHERA can cause severe diarrhea. Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity. ADVERSE REACTIONS Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA. The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%). USE IN SPECIFIC POPULATIONS Pediatric UseSafety and efficacy of ZIIHERA have not been established in pediatric patients. Geriatric UseOf the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older. No overall differences in safety or efficacy were observed between these patients and younger adult patients. About Vyxeos® (daunorubicin and cytarabine) liposome for injectionVyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor. In the U.S., Vyxeos (daunorubicin and cytarabine) liposome for injection is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.3 More information about Vyxeos in the United States, including Full Prescribing Information and BOXED Warning, is available here. Important Safety Information for VYXEOS® WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products. VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients. VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding. VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as: shortness of breath or trouble breathing swelling or fluid retention, especially in the feet, ankles, or legs unusual tiredness VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as: trouble breathing severe itching skin rash or hives swelling of the face, lips, mouth, or tongue VYXEOS contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders. VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site. VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS. The most common side effects are bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568. About Defitelio® (defibrotide sodium)In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016, and it is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication.6 Please see full Prescribing Information for Defitelio in the United States . In Europe, defibrotide is marketed under the name Defitelio® ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients after HSCT therapy. In Europe, Defitelio is indicated in patients over one month of age. ▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC (https://www.ema.europa.eu/en/documents/product-information/defitelio-epar-product-information_en.pdf) The full Summary of Product Characteristics of Defitelio in Europe is available here. Important Safety Information for Defitelio® Defitelio should not be given to patients who are: Currently taking anticoagulants or fibrinolytics Allergic to Defitelio or any of its ingredients Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision. Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately. The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds. Defitelio is not approved for the prevention of VOD. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to expectations of top-line PFS results in the second quarter of 2025 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with pharmaceutical product development, and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2023 , as supplemented by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 , and future filings and reports by Jazz Pharmaceuticals . Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made. Contacts: Jazz Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 Jazz Investor Contact: Jeff Macdonald Executive Director, Investor Relations Jazz Pharmaceuticals plc investorinfo@jazzpharma.com Ireland +353 1 634 3211 U.S. +1 650 496 2717 View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-to-present-advancements-in-solid-tumors-and-blood-cancer-research-at-san-antonio-breast-cancer-symposium-and-american-society-of-hematology-annual-meeting-302320929.html SOURCE Jazz Pharmaceuticals plc

Phase 3Clinical ResultDrug ApprovalFast TrackBreakthrough Therapy

100 Deals associated with Acetyladriamycin

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KEGG	Wiki	ATC	Drug Bank
D10787	-	L01DB02	DB00694

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Kaposi Sarcoma	FR	Galen US, Inc.	19 Aug 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	US	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	BE	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	CA	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	DK	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	FR	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	IL	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	IT	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	NL	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	ES	Daiichi Sankyo Co., Ltd.	15 Aug 2018
Acute Myeloid Leukemia	Phase 2	SE	Daiichi Sankyo Co., Ltd.	15 Aug 2018

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCRI AML18 (ASH2024)	Phase 2	Acute Myeloid Leukemia MDS-related gene mutations	506	CPX-351	ufoxzhdufh(cbbsusokgz) = xmpxattsry rostebkqjr (ybawsblxsc, 0.57 - 0.93) View more	Negative	07 Dec 2024
				DAGO2	ufoxzhdufh(cbbsusokgz) = xmfidebfya rostebkqjr (ybawsblxsc, 0.73) View more
NCT03724084 (CTgov)	Phase 1/2	Acute Myeloid Leukemia	6	Daunorubicin+Pinometostat+Cytarabine+Daunorubicin Hydrochloride (Cohort II (Higher Dose Pinometostat))	vvtzislwof(iygoryqeyf) = tsoagxbmiz tbvcuwfvkp (gnmbogaphb, wqmqdcciwn - oqhfxmgidd) View more	-	11 Jun 2024
				Daunorubicin+Pinometostat+Cytarabine+Daunorubicin Hydrochloride (Cohort I (Higher and Lowers Dose Pinometostat))	xqtfwhjsjx(vhcciqhdtu) = hwrctoxtvp uitcgdesjo (autoavtgkf, kjtokubycr - fmduxsqqay) View more
NCT00866749 (CTgov)	Phase 2	Acute Lymphoblastic Leukemia \| Adult Lymphoblastic Lymphoma	120	Daunorubicin+cyclophosphamide+doxorubicin+PEG-asparaginase+Thioguanine+Mercaptopurine+Methotrexate+Vincristine+Cytarabine	irjnlxwalk(xodfmnjukn) = fkkcmvbvxe ejklmlwxnx (tyoihplcue, ivgfifsfxa - fefhsoomhr) View more	-	10 Sep 2019
NCT00610883 (CTgov)	Phase 2	Non-Hodgkin Lymphoma	17	LSA4+Cyclophosphamide+Daunomycin+BCNU+Methotrexate	spfwuixwhu(eydoprnmwf) = xsncjteocp evozbkvwrc (uokbxytrts, alyoefvhyb - dauvcxgcit) View more	-	25 Jan 2016
NCT00176462 (CTgov)	Phase 2	Acute Lymphoblastic Leukemia	60	L-asparaginase+Daunomycin+cyclophosphamide+Hydrocortisone+6-thioguanine+aminopterin+6-mercaptopurine+Leucovorin+dexamethasone+Vincristine+Methotrexate+Cytarabine (Arm 2 High Risk)	rzsvavdcnk(xhjmotknbw) = pjfjecgsvj myyukljwgb (mryvawqgwg, glevtvjbmk - ghkcgeapzb) View more	-	09 Jun 2014
				L-asparaginase+Daunomycin+Hydrocortisone+6-mercaptopurine+Leucovorin+dexamethasone+Methotrexate+Vincristine+Cytarabine (Arm 1 Standard Risk)	bflsqbwilv(mbzxdtukgk) = ghcfwehayn xdgttteeli (bazubrebqk, flkrynssoz - qhzolskyvd) View more
ASCO2005	Not Applicable	Colonic Cancer \| Prostatic Cancer \| Non-Small Cell Lung Cancer	21	Targeted liposomal daunorubicin (LDauno)	vpgaoovlpv(lfztsgdlob) = mnxiuuyzop cbtwdotgod (lmllzvjpqa )	-	01 Jun 2005
				Filgrastim (F)	vpgaoovlpv(lfztsgdlob) = rfxygcymga cbtwdotgod (lmllzvjpqa )
IAS2004	Not Applicable	Kaposi Sarcoma	76	Liposomal Daunorrubicin (Daunoxome)	kjpgjlwlvm(dzjhxdyoaf) = pancytopenia being the most frequent reported effects fsqswbfwek (sgahryriwu ) View more	-	01 Jan 2004
				Liposomal Daunorrubicin (daunoxome) (Other treatment options)

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