QT interval

TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

Retrieved on: 
Lunedì, Febbraio 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Fever, Progression-free survival, PFS, AstraZeneca, Heart, Periodic breathing, QT interval, MD, Chemoradiotherapy, Cough, Pemetrexed, Winship Cancer Institute, QT, OS, Electrolyte, Cardiomyopathy, Lung cancer, Safety, Emory University, CRT, LAURA, ILD, Patient, LVEF, Brain, Pharmaceutical industry

In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.

Key Points: 
  • In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.
  • Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal.
  • TAGRISSO is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial .
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

TAGRISSO® (osimertinib) with the addition of chemotherapy approved in the US for patients with EGFR-mutated advanced lung cancer

Retrieved on: 
Sabato, Febbraio 17, 2024
Oncology, FDA, Health, General Health, Pharmaceutical, Biotechnology, Heart, QT interval, Food, Pemetrexed, Risk, Cardiomyopathy, Electrolyte, Death, Patient, LVEF, Priority review, Pharmaceutical industry

This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.

Key Points: 
  • This approval reinforces TAGRISSO as the backbone of EGFR-mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.
  • The safety profile of TAGRISSO with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines.
  • Adverse event (AE) rates were higher in the TAGRISSO plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs.
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

Kura Oncology Reports Positive Preliminary Ziftomenib Combination Data in Acute Myeloid Leukemia

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Martedì, Gennaio 30, 2024
KURA, Failure, Acute myeloid leukemia, Venetoclax, Research, Division, MHS, Patient, Safety, QT interval, AML, Bone marrow, MBBS, QD, Yale Cancer Center, Disease, Therapy, Postcholecystectomy syndrome, Risk, ID, Cancer, Kura, Pharmaceutical industry

Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.

Key Points: 
  • Continuous daily dosing of ziftomenib at 200 mg QD has been well tolerated and the safety profile consistent with features of underlying disease and backbone therapies.
  • The overall response rate (ORR) among R/R patients treated with ziftomenib and ven/aza was 53% (8/15).
  • As of the data cutoff, 80% (16/20) of patients remain on trial, including 100% (11/11) of all NPM1-m patients.
  • “We are highly encouraged by these preliminary combination data for ziftomenib and believe they support advancement into the frontline AML population,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology.

Xspray Pharma’s XS003 Achieves Superior Bioavailability Milestone, Matching TASIGNA® at Reduced Dosage

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Martedì, Novembre 21, 2023
Research, FDA, Clinical Trials, Cardiology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, NDA, Risk, Doctor of Philosophy, QT interval, Absorption, PKI, Sudden death, Pharmaceutical industry

This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations.

Key Points: 
  • This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations.
  • “Our goal is to submit the NDA to the FDA in the second half of 2024 once all required studies are finalized; such as e.g.
  • food effect and proton pump inhibitor interaction,” says Xspray Pharma Chief Executive Officer, Per Andersson, PhD.
  • We have now demonstrated that XS003 exhibits improved absorption, matching TASIGNA at lower dose.”

Syndax Presents Positive Data from Pivotal AUGMENT-101 Trial of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia at Late-Breaking Oral Presentation During 65th ASH Annual Meeting

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Martedì, Dicembre 12, 2023
Data, Principal, Trae Waynes, Pivotal, Associate professor, Food, Postcholecystectomy syndrome, Transplant, City, HSCT, Acute myeloid leukemia, ASH, Cytopenia, DS, Haematopoietic system, Publication, MRD, Division, QT interval, CRC, CRH, SNDX, CYP3A4, Acute leukemia, Nausea, ORR, 65th Armoured Regiment (India), AML, Society, Female, Poster, ALL, Safety, Vaccine, Pharmaceutical industry, Nursing, Leukemia, Hematology, Patient

The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."

Key Points: 
  • The pivotal results were featured in a late-breaking oral presentation titled "Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemia: Topline Efficacy and Safety Results from the Pivotal AUGMENT-101 Phase 2 Study."
  • Minimal residual disease (MRD) status was assessed in 10 of the 13 patients who achieved a CR/CRh, 70% (7/10) of whom were MRD negative.
  • In adults with AML (n=51), the CR/CRh rate was 37.3% and ORR was 68.6%, with 40% of responders proceeding to HSCT.
  • Copies of the ASH presentations are available in the Publications and Meeting Presentations section of Syndax's website.

Clario's Oncology Webinar Series Part 3 -- Integrating Objectively Measured Safety Endpoints and Patient-Reported Outcomes in Oncology Trials: A Scientific Approach

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Mercoledì, Novembre 22, 2023
Safety, Patient safety, Consultant, Science, Pros, Medicine, Part, FDA, CVI, QT interval, MD, EST, Doctor of Philosophy, Oncology, Knowledge, Outline, Circulation: Cardiovascular Imaging, Drug development, Blood pressure, Nursing, Medical imaging, Clario Tech, Cardiology

TORONTO, Nov. 22, 2023 /PRNewswire-PRWeb/ -- In the ever-evolving landscape of drug development within oncology, the importance of collecting high-quality data across multiple endpoints cannot be overstated. This data plays a pivotal role in determining the success of a drug. The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug's safety profile, influencing overall benefit-risk considerations. Through this webinar, Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials.

Key Points: 
  • In this free webinar, Part 3 of Clario's Oncology Webinar Series, learn about a scientific approach to enhancing safety and tolerability assessments in oncology trials.
  • The integration of objective safety measurements with patient-reported outcomes is now essential in characterizing a drug's safety profile, influencing overall benefit-risk considerations.
  • Through this webinar, Clario invites you to explore our comprehensive scientific approach to enhancing safety and tolerability assessments in oncology trials.
  • For more information, or to register for this event, visit Clario's Oncology Webinar Series .

VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

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Giovedì, Novembre 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, QT interval, Cardiac arrest, National Center for Health Research, Acute myeloid leukemia, ECG, European Commission, Hypokalemia, Committee, European Directive on Traditional Herbal Medicinal Products, Febrile neutropenia, MD, Professor, News, University Hospital Heidelberg, EC, Maintenance, Pneumonia, Arrhythmia, Ventricular fibrillation, ALAN, Civil service commission, Daiichi Sankyo, Risk, TSE, HR, Leukemia, FLT3, Committee for Medicinal Products for Human Use, Safety, German Cancer Research Center, European, Patient, Death, Neutropenia, AML, Nursing, Pharmaceutical industry, EU, Lancet

VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2

Key Points: 
  • VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2
    The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet .
  • The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%).
  • QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation.
  • Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

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Giovedì, Novembre 2, 2023
Trae tha Truth, ECOG, Vomiting, CYP3A4, WT, Abstract, NPM1, KMT2A, OBD, PK, DLT, TKD, Cancer, Diabetes, ORR, Clinical study design, Safety, Patient, Cohort, HSCT, SETBP1, CR, DSM-IV codes, NUP214, DOR, Dicarboxylic acid, CRi, ASH, CD135, QT interval, RFS, FLT3, Arm, Cellular, FMS, Transplant, ALL, Toxic leukoencephalopathy, Gene family, Survival, Postcholecystectomy syndrome, DS, Trial of the century, Incidence, CRC, Infrared spectroscopy correlation table, AL, Osteopathic medicine in Canada, MN1, BID, CNS, KRAS, ATD, NUP98, Society, WBC, Pharmacokinetics, CLL, Acute leukemia, Common, ITD, Toxicity, AML, Cardiovascular disease, Pharmaceutical industry, Dentistry, Vaccine, Decitabine, DLBCL

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Biomea Fusion Reports Third Quarter 2023 Financial Results and Corporate Highlights

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Lunedì, Ottobre 30, 2023
Week, DLBCL, FDA, Research, Research and development, NSCLC, Trial of the century, IND, DSM-IV codes, Food, Diabetes, Health Canada, G&A, BID, CRS, KRAS, Investment, R, NUP98, Glycated hemoglobin, CLL, CD135, Disease, Clinical trial, CRC, Cancer, QT interval, Menin, MM, FLT3, Safety, PDAC, Patient, FMS, Administration, AML, Mutation, Pharmaceutical industry, Medical imaging, Cryptocurrency, Osteopathic medicine in Canada

Both studies are now open for enrollment more than a quarter ahead of schedule.

Key Points: 
  • Both studies are now open for enrollment more than a quarter ahead of schedule.
  • Finally in this quarter, we also initiated the clinical study of our second, Biomea-discovered investigational covalent inhibitor, BMF-500, a novel FLT3 inhibitor.
  • Continued to advance development candidates derived from Biomea’s proprietary FUSION™ System platform to discover novel covalently binding small molecules.
  • G&A expenses were $17.1 million for the nine months ended September 30, 2023 compared to $15.2 million for the same period in 2022.

Syndax Announces Updated Data Supporting Impressive Clinical Profile of Revumenib in Genetically-Defined Acute Leukemias to Be Presented at the 65th ASH Annual Meeting

Retrieved on: 
Giovedì, Novembre 2, 2023
CR, CRP, Acute myeloid leukemia, Food, Trae Waynes, Thrombocytopenia, Decitabine, Febrile neutropenia, Safety, CRH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Phenotype, Maintenance, Poster, Society, IDMC, ASH, DLT, Abstract, MRD, QT interval, ORR, SNDX, SAVE, NDA, Acute leukemia, Cellular, Transplant, ALL, AML, Neutropenia, Phase 1, HSCT, Pharmaceutical industry, Dentistry, Patient

WALTHAM, Mass., Nov. 2, 2023 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that updated data from multiple trials across its clinical program for revumenib, the Company's highly selective, oral menin inhibitor, will be featured in three poster presentations at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023, in San Diego, California. Copies of the abstracts are now available online via the ASH website at www.hematology.org.

Key Points: 
  • The Company previously announced positive topline data from the protocol-defined pooled analysis of the pivotal Phase 2 portion of the AUGMENT-101 trial.
  • Based on the Independent Data Monitoring Committee (IDMC) recommendation, the Company stopped the trial to further accrual in the KMT2Ar cohorts.
  • Full data from the pivotal portion of the study will be reported at the meeting.
  • Title: Revumenib Monotherapy in Patients with Relapsed/Refractory KMT2Ar Acute Leukemias: Efficacy and Safety Results from the Augment-101 Phase 1/2 Study
    Session Name: 616.