International Prognostic Scoring System

Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and Breadth of Effect Across MDS Subgroups with Imetelstat in Lower Risk MDS

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Monday, December 11, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Yale Cancer Center, Associate, International Prognostic Scoring System, Quality, IPSS, VAF, ASH, Acute myeloid leukemia, Cytopenia, Risk, Pros, Corporation, Yale school, Fatigue, Patient, Thrombocytopenia, Research, Periodic breathing, Imetelstat, Quality of life, Internal medicine, MDS, Neutropenia, MBBS, Yale School of Medicine, Bleeding, Survival, Pain, AML, Geron Corporation, Society, Iron overload, Mutation, RBC, Pharmaceutical industry, Dietary supplement, Lancet, Geron, SF3B1, Blood, Medicine, Hematology

The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.

Key Points: 
  • The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.
  • Overall, durable 24-week and 1-year RBC-TI responses were observed with imetelstat in all lower- and higher-risk subgroups.
  • This analysis suggests clinical benefit of imetelstat across different molecularly defined subgroups and independent of the underlying molecular mutation pattern.
  • This analysis indicates that achievement of RBC-TI was associated with improved survival, suggesting that transfusion dependence is a modifiable predictor of clinical outcomes in lower risk MDS.

Geron IMerge Phase 3 Presentations at Upcoming ASH Annual Meeting Reinforce Significant Durability and Breadth of Effect of Imetelstat in Lower Risk MDS

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Thursday, November 2, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, International Prognostic Scoring System, IPSS, Survival, FDA, RUNX1, H. Lee Moffitt Cancer Center & Research Institute, VAF, Food, TP53, Thrombocytopenia, Literature, EZH2, MDS, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Imetelstat, Society, ASXL1, SF3B1, Transfusion-dependent anemia, Geron Corporation, Risk, Abstract, TI, EMA, Corporation, LR, Anemia, ETV6, Patient, Neutropenia, Mutation, Pharmaceutical industry, Communications satellite, ASH

Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.

Key Points: 
  • Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.
  • “Additionally, our abstract showcasing a real-world data population level analysis of over 5,000 lower risk MDS patients adds to the significant literature suggesting a correlation between TI and improvement in survival.
  • This analysis suggests imetelstat has clinical activity in lower risk MDS patients independent of risk categories.
  • Achievement of durable TI was associated with improved survival, supporting the clinical benefit of achieving transfusion independence in lower risk MDS.

OJJAARA™ (momelotinib) Now Available from Onco360 For the Treatment of Intermediate or High-Risk Myelofibrosis (MF), Including Primary MF or Secondary MF [Post-Polycythemia Vera (PV) and Post- Essential Thrombocythemia (ET)], in Adults with Anemia

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Monday, September 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, GSK plc, System, Prevalence, Primary myelofibrosis, International Prognostic Scoring System, Survival, National Comprehensive Cancer Network, Pharmacy, MF, PV, NCCN, Pancreatic serous cystadenoma, Incidence, ET, Specialty pharmacy, Patient, Anemia, Diagnosis, MPN, IPSS, Pharmaceutical industry

Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by GlaxoSmithKline for OJJAARA™ (momelotinib).

Key Points: 
  • Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by GlaxoSmithKline for OJJAARA™ (momelotinib).
  • OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.
  • “Onco360 is grateful for the opportunity to partner with the team at GlaxoSmithKline and become a specialty pharmacy provider for OJJAARA,” said Benito Fernandez, Chief Commercial Officer.
  • The median age at time of original primary MF diagnosis is 67 years old.

First-in-Class Investigational SX-682 Demonstrates Single-Agent Efficacy in Patients with Hypomethylating Agent Failure Myelodysplastic Syndromes

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Friday, December 9, 2022
NIH, ORR, Microdeletion syndrome, International Prognostic Scoring System, IWG, MD, Research institute, Doctor of Philosophy, Lenalidomide, MDSC, Society, IPSS, Lung, Patient, Cancer, Neutrophil, Myelodysplastic syndrome, Abstract, National Heart, Lung, and Blood Institute, CXCR2, Tumor microenvironment, Bone marrow, AML, Clinical trial, Risk, Multimedia, Safety, The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, NHLBI, Transfusion-dependent anemia, MDS, MCR, ASH, CXCR1, BID, Pharmaceutical industry, Dietary supplement, HMA

AUBURN, Wash., Dec. 9, 2022 /PRNewswire/ -- Syntrix Pharmaceuticals today announced results from a single-arm, open-label Phase 1 trial of single-agent SX-682, an investigational CXCR1/2 inhibitor, in patients with any-risk myelodysplastic syndromes (MDS) in whom front-line hypomethylating-agent (HMA) had failed, a high unmet need population.  Results support the clinical activity of SX-682.  The data will be presented by David Sallman, MD of the H. Lee Moffitt Cancer Center and Research Institute, an investigator for the clinical trial, during an afternoon oral session on December 12, 2022 at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #855).

Key Points: 
  • All patients were transfusion-dependent and all had failed prior HMA and 24% lenalidomide (range 1-4 failed prior therapies).
  • The median age was 76, and patients were low (n=1), intermediate-1 (n=10), intermediate-2 (n=5) and high (n=1) risk by the International Prognostic Scoring System (IPSS).
  • Myelodysplastic syndromes (MDS) are a type of cancer caused by poorly formed or dysfunctional blood cells in the bone marrow.
  • Patients are treated with BID doses of SX-682 in six continuous 28-day cycles with responding patients continuing treatment.

Molecular International Prognostic Scoring System Developed for Myelodysplastic Syndromes

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Sunday, June 12, 2022
International Working Group on Neurotransmitter Related Disorders, Memorial Sloan Kettering Cancer Center, Research, Catalog, Marie Cassidy, International Prognostic Scoring System, Analysis, IPSS, AML, Gene, MDS, Cytogenetics, Myelodysplastic syndrome, GLOBE, Patient, Risk, Adoption, Diagnosis, The New England Journal of Medicine, IWG, Leukemia, Death, Prognosis, Medical device, Pharmaceutical industry

YARDVILLE, N.J., June 12, 2022 (GLOBE NEWSWIRE) -- Today, the MDS Foundation announced the development of a new prognostic scoring system, the IPSS-Molecular, that will significantly improve risk stratification upon diagnosis to better inform the way treatment plans are built for patients with Myelodysplastic Syndromes.

Key Points: 
  • YARDVILLE, N.J., June 12, 2022 (GLOBE NEWSWIRE) -- Today, the MDS Foundation announced the development of a new prognostic scoring system, the IPSS-Molecular, that will significantly improve risk stratification upon diagnosis to better inform the way treatment plans are built for patients with Myelodysplastic Syndromes.
  • For more than two decades, MDS patient risk stratification at diagnosis was based on diagnostic blood counts, morphology, and cytogenetics through the International Prognostic Scoring System.
  • The creation of an effective set of prognostic guidelines was especially important for MDS because current clinical courses are very heterogeneous.
  • The results of this investigation, led by Drs Elsa Bernard, Elli Papaemmanuil and IWG colleagues, 'Molecular International Prognostic Scoring System for MDS (IPSS-M)', have just been published in the June 12, 2022 issue of the New England Journal of Medicine Evidence.

Geron Announces Completion of Patient Enrollment in IMerge Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes

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Monday, October 18, 2021
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Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the completion of patient enrollment in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, today announced the completion of patient enrollment in the IMerge Phase 3 clinical trial to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS).
  • Completing patient enrollment in IMerge Phase 3 brings us one step closer to delivering imetelstat as a potential treatment alternative for patients with lower risk MDS who are relapsed or refractory to ESAs.
  • IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent.
  • The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis.

Antengene's Partner Karyopharm Therapeutics Announces Updated Data of Eltanexor in Patients with Hypomethylating Agent Refractory MDS

Retrieved on: 
Wednesday, June 9, 2021
International Prognostic Scoring System, Myelodysplastic syndrome

This Phase I/II study evaluated single-agent eltanexor in patients with higher-risk MDS, ie, high-risk or intermediate-2 MDS by the International Prognostic Scoring System (IPSS) and 5%-19% myeloblasts.

Key Points: 
  • This Phase I/II study evaluated single-agent eltanexor in patients with higher-risk MDS, ie, high-risk or intermediate-2 MDS by the International Prognostic Scoring System (IPSS) and 5%-19% myeloblasts.
  • Out of the 20 patients enrolled, 15 patients were evaluable for efficacy and constitute the population studied in this analysis.
  • In the 10 mg cohort (n=5), all patients derived clinical benefit with 3 patients (60%) reaching mCR and 2 patients (40%) reaching SD.
  • Four patients had hematologic improvement (HI) and became transfusion-independent for at least 8 weeks including 2 patients with tri-lineage HI.

Takeda Expands Oncology Research, Demonstrating Commitment to Patient Community at 15th International Symposium on Myelodysplastic Syndromes

Retrieved on: 
Tuesday, May 7, 2019
Health, Biotechnology, Oncology, Pharmaceutical, International Prognostic Scoring System, RTT, Myelodysplastic syndrome, Clinical medicine, Chronic myelomonocytic leukemia

Thursday, May 9, 11:45 a.m. 12:45 p.m. (Tivoli Congress Hall).

Key Points: 
  • Thursday, May 9, 11:45 a.m. 12:45 p.m. (Tivoli Congress Hall).
  • There are several classifications of MDS lower risk to higher-risk determined by blood counts, blast counts, mutations and cytogenetics.
  • Higher-risk disease is defined as intermediate, high or very high risk on the International Prognostic Scoring System Revised (IPSS-R), and these patients often have a poorer prognosis.
  • Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases.