International Prognostic Index

Adicet Bio Reports Positive Data from Ongoing ADI-001 Phase 1 Trial in Patients with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL)

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월요일, 6월 26, 2023
Research, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Graft-versus-host disease, Senior, CD19, Tornado outbreak of May 4–6, 2007, ACET, CRS, Bio, NHL, Cancer, Cmax, CAR, Patient, IPI, International Prognostic Index, CR, Bone marrow, FDA, DL2, ORR, Safety, Pharmaceutical industry, Vaccine

“Autologous CD19 CAR T therapies were studied on CAR T naïve patients with a median of 3 prior lines of therapy.

Key Points: 
  • “Autologous CD19 CAR T therapies were studied on CAR T naïve patients with a median of 3 prior lines of therapy.
  • In contrast, the ADI-001 Phase 1 trial enrolled patients with a median of 4 lines of prior therapy and, importantly, 50% had previously progressed on autologous CAR T therapy.
  • Unfortunately, approximately 60-70% of these patients progress, which represents a significant unmet medical need,” said Chen Schor, President and Chief Executive Officer of Adicet Bio.
  • Table 1 – Summary of Phase 1 ADI-001 Preliminary Efficacy Data as of the May 4, 2023 data-cut date:

FDA Approves Genentech’s Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-cell Lymphoma

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수요일, 4월 19, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Rituximab, Vincristine, DLBCL, Cyclophosphamide, NOS, PFS, ROG, RO, Prednisone, HIV disease progression rates, Patient, Standard of care, Risk, Doxorubicin, IPI, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, International Prognostic Index, Food, Roche, Pharmaceutical industry, Polatuzumab vedotin, Genentech

DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States.

Key Points: 
  • DLBCL is an aggressive, hard-to-treat disease and is the most common form of non-Hodgkin’s lymphoma in the United States.
  • Limited progress has been made in improving patient outcomes in previously untreated DLBCL over the last two decades.
  • This approval follows the FDA Oncologic Drugs Advisory Committee (ODAC) vote of 11 to 2 in favor of Polivy in combination with R-CHP for previously untreated DLBCL.
  • More than 70 countries have approved this Polivy combination for the treatment of adult patients with previously untreated DLBCL, including in the EU, UK, Japan, Canada and China.

Taiho Oncology and Astex Pharmaceuticals Present Overall Survival Data for Oral Decitabine and Cedazuridine (INQOVI®, ASTX727) in Patients With MDS and CMML Harboring TP53 Mutations at 64th ASH Annual Meeting

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월요일, 12월 12, 2022
Pneumonia, Intracranial hemorrhage, Society, Research, Toxicity, Anemia, Aplastic anemia, Child, Acute kidney injury, Ōtsuka, NCCN, Woman, Patient, Sepsis, MDS, Bone marrow suppression, Risk, CMML, Thrombocytopenia, Fatal, Microdeletion syndrome, MLF, International Prognostic Index, AUC, MOS, Birth, Febrile neutropenia, Clinical trial, National Comprehensive Cancer Network, Abstract, Neutropenia, Creatinine, ESRD, Pregnancy, De novo, Decitabine, Chronic kidney disease, TP53, Confidence interval, ASH, Mutation, Chronic myelomonocytic leukemia, Route of administration, Internal medicine, Sudden death, LFS, Kidney, Septic shock, Myelodysplastic syndrome, Vanderbilt University, Astex, Chromosomal deletion syndrome, IV, Fetus, Pharmaceutical industry, Birth control, Epidemiology, MD

PRINCETON, N.J. and PLEASANTON, Calif., Dec. 12, 2022 /PRNewswire/ -- Taiho Oncology, Inc. and Astex Pharmaceuticals, Inc. today announced preliminary data from the Phase 3 ASCERTAIN trial assessing overall and leukemia-free survival in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML) harboring biallelic TP53 mutations following treatment with oral decitabine and cedazuridine (ASTX727). The data are being presented today as an oral presentation (Abstract #854) at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.

Key Points: 
  • The data are being presented today as an oral presentation ( Abstract #854 ) at the 64th American Society of Hematology (ASH) Annual Meeting in New Orleans.
  • In the study, the population of patients harboring a TP53 mutation (44 of 125 patients) was characterized by allelic status: 14 patients had biallelic mutations and 30 patients had monoallelic mutations without other chromosomal deletions.
  • The primary endpoint of the study was total 5-day area-under-the-curve (AUC) equivalence of oral decitabine and cedazuridine and IV decitabine.
  • Astex, the Astex logo, Taiho Oncology, the Taiho Oncology logo and INQOVI are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries.

Adicet Bio Reports ASH Abstract Data from Ongoing ADI-001 Phase 1 Trial in Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL)

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목요일, 11월 3, 2022
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, Private Securities Litigation Reform Act, Society, DLBCL, Mantle cell lymphoma, Canadian Aviation Regulations, Diffuse large B-cell lymphoma, FDA, Acute leukemia, CD19, B-cell lymphoma, International Prognostic Index, Annual report, U.S. Securities and Exchange Commission, MD Anderson Cancer Center, SEC, Regulation Fair Disclosure, Disclosure, Company, Neoplasm, Food, CAR, Indolent lymphoma, ASH, CR, Security (finance), Patient, Cancer, Pharmacokinetics, ORR, Male, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NHL, IPI, COVID-19, Kinetics, Bio, Lymphoid leukemia, DL2, Flow cytometry, Risk, ACET, Safety, Poster, CRS, Trial of the century, Nasdaq, Investigator's brochure, Regulation, Follicular lymphoma, Pharmaceutical industry, Vaccine, Medical device

The abstract outlines a summary of clinical data as of a July 15, 2022 data-cut date.

Key Points: 
  • The abstract outlines a summary of clinical data as of a July 15, 2022 data-cut date.
  • We look forward to providing additional clinical data from a later data-cut date during the ASH Annual Meeting, said Francesco Galimi, M.D., Ph.D., Chief Medical Officer of Adicet Bio.
  • There were eight patients with large B-cell lymphoma (LBCL) and one with mantle cell lymphoma.
  • ET to discuss recent data from its ongoing Phase 1 clinical study of ADI-001 in relapsed or refractory aggressive B-cell NHL.

Adicet Bio Reports Positive Clinical Update from ADI-001 Phase 1 Trial in Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL)

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목요일, 5월 26, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Department, DL2, Regulation Fair Disclosure, ID, Company, Follicular lymphoma, Lymphoid leukemia, Graft-versus-host disease, MD Anderson Cancer Center, Annual general meeting, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Private Securities Litigation Reform Act, Indolent lymphoma, Toxic epidermal necrolysis, Food, U.S. Securities and Exchange Commission, Nasdaq, Kite Pharma, Webcast, Patient, Disclosure, University, Clinical Lymphoma, Myeloma & Leukemia, Risk, IPI, NHL, Bio, Pharmacokinetics, Society, Pneumonia, International Prognostic Index, COVID-19, American Society of Clinical Oncology, Trial of the century, Regulation, FDA, PET/CT, Female, B-cell lymphoma, Safety, CRS, ASCO, CAR, SEC, CR, Cancer, Mantle cell lymphoma, ACET, Annual report, Pharmaceutical industry, Vaccine, Medical imaging, Immunotherapy

The abstract provides a summary of clinical data as of a February 14, 2022, data-cut date.

Key Points: 
  • The abstract provides a summary of clinical data as of a February 14, 2022, data-cut date.
  • We are very pleased to see the continued positive data resulting from our ongoing Phase 1 clinical trial evaluating ADI-001 in relapsed/refractory NHL.
  • There were five patients with large B-cell lymphoma and one with mantle cell lymphoma.
  • Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer.

Global Hodgkin's Lymphoma Market Spotlight Report, 2018 - Takeda Leads Industry Sponsors with by Far the Highest Number of Clinical Trials for Hodgkin's Lymphoma, Followed by Merck & Co - ResearchAndMarkets.com

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수요일, 6월 19, 2019
Professional services, Consulting, Health, RTT, Cancer, Medicine, Hematology, Hodgkin's lymphoma, Lymphoma, Clinical trial, International Prognostic Index

The majority of industry-sponsored drugs in active clinical development for Hodgkin's lymphoma are in Phase II, with no drugs in Phase III.

Key Points: 
  • The majority of industry-sponsored drugs in active clinical development for Hodgkin's lymphoma are in Phase II, with no drugs in Phase III.
  • The US has a substantial lead in the number of Hodgkin's lymphoma clinical trials globally.
  • Takeda has the highest number of completed clinical trials for Hodgkin's lymphoma, with 46 trials.
  • Takeda leads industry sponsors with by far the highest number of clinical trials for Hodgkin's lymphoma, followed by Merck & Co.