CD30

Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Martedì, Marzo 12, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Rituximab, Survival, Lymphoma, Inc., Disease, Patient, PFE, Brentuximab vedotin, Lenalidomide, Safety, CD30, PFS, Food, FDA, DLBCL, Pharmaceutical industry

Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

Key Points: 
  • Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).
  • The safety and tolerability of ADCETRIS in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with ADCETRIS in clinical trials.
  • “This is the third Phase 3 study in a type of lymphoma to demonstrate an overall survival benefit for an ADCETRIS combination.
  • Pfizer plans to share the ECHELON-3 data with the U.S. Food and Drug Administration (FDA) to potentially support regulatory filing in the U.S.

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Mercoledì, Aprile 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Martedì, Novembre 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Calliditas Presents Additional Data Analyses from the NefIgArd Phase 3 trial at the American Society of Nephrology (ASN) Kidney Week 2023

Retrieved on: 
Martedì, Novembre 7, 2023
Science, Glomerulosclerosis, B-cell activating factor, DSM-IV codes, Ramipril, Biomarker, Rare, Budesonide, EGFR, Kidney, Person, CD23, Fibrosis, GALT, ACE, Protein, Society, American Society of Nephrology, BAFF, CD30, Urine, ASN, Record, Serum, CET, NOX, Immunoglobulin A, CALT, Histology, Patient, CD27, Alport syndrome, Pharmaceutical industry, Vaccine, IgA nephropathy, Publication, Alport

The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.

Key Points: 
  • The Phase 3 double-blind, randomized NefIgArd study evaluated the impact of Nefecon, a novel targeted-release formulation of budesonide, vs placebo on eGFR in adults with IgAN.
  • The 2-year study period consisted of nine months of treatment with Nefecon (16 mg/day) or placebo, followed by a 15-month follow-up period off the study drug.
  • Levels of secretory IgA and fatty acid-binding protein, a gut permeability marker, were unchanged at these same time points.
  • Together, these biomarker data add to the body of evidence supporting a disease-modification effect for Nefecon, including modulation of immune complex formation.

Seagen Highlights First Solid Tumor Data for an ADCETRIS® (brentuximab vedotin) Immunotherapy Combination and Preclinical Data for Novel CD30-Directed Antibody-Drug Conjugate at Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Venerdì, Novembre 3, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Brentuximab vedotin, DCR, Society for Immunotherapy of Cancer, Pembrolizumab, Head, PD-1, Development, CD8, SITC, Immunotherapy, ADC, CD30, Inc., Clinical trial, Transportation Research Part E, Research and development, Annual general meeting, ORR, Seagen, RECIST, Tumor microenvironment, Lung cancer, Melanoma, Safety, Society, ADCETRIS, Patient, Toxicity, Neck, Pharmaceutical industry, Vaccine, NSCLC

The studies were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place November 3-5, 2023, in San Diego.

Key Points: 
  • The studies were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place November 3-5, 2023, in San Diego.
  • “The combination of ADCETRIS and a PD-1 inhibitor to treat solid tumors are intriguing and support continued research,” said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen.
  • The study design included melanoma patients who were treated in the study within 90 days of receiving prior anti-PD-1 therapy.
  • Preclinical data suggest that SGN-35T may be highly effective, like ADCETRIS, with the potential for improved tolerability.

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

Retrieved on: 
Mercoledì, Ottobre 18, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Survival, Brentuximab vedotin, Christie, TAK, Progression-free survival, CHMP, European Commission, IRF, Committee, Bleomycin, Vinblastine, European Directive on Traditional Herbal Medicinal Products, AVD, Doxorubicin, PFS, EC, University of Manchester, Civil service commission, Hodgkin lymphoma, ADC, CD30, ABVD, Risk, Dacarbazine, University, The Christie NHS Foundation Trust, Committee for Medicinal Products for Human Use, Hatim al-Awni, Overalls, Safety, ADCETRIS, Patient, OS, Lymphoma, Medical device, Medical imaging, Pharmaceutical industry, Takeda, Fellow of the Academy of Medical Sciences

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
  • ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
  • The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.
  • “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, M.D., head of global medical affairs oncology, Takeda.

Tessa Therapeutics Announces Positive Results from CD30 CAR-T Combination Study with Nivolumab in 2nd line Hodgkin Lymphoma

Retrieved on: 
Venerdì, Giugno 16, 2023
Well, Hodgkin lymphoma, Cytokine release syndrome, CRS, Associate professor, Lymphoma, Malignancy, EOT, CHL, TT11, MD Anderson Cancer Center, International Conference on Population and Development, ASCT, Patient, Risk, University, PET/CT, Neoplasm, Therapy, CD30, ACTION, Conference, End, Safety, Bone marrow, Pharmaceutical industry, Medical imaging, Nivolumab

TT11 is currently being investigated in combination with Nivolumab in Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients after frontline therapy failure (NCT05352828).

Key Points: 
  • TT11 is currently being investigated in combination with Nivolumab in Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients after frontline therapy failure (NCT05352828).
  • Study protocol involves patients being treated with 2 cycles of Nivolumab, followed by a single infusion of CD30.CAR-T preceded by lymphodepletion (LD) chemotherapy.
  • A total of 15 patients were enrolled of which 13 were treated with Nivolumab + CD30 CAR-T therapy.
  • These results offer the potential to re-define Hodgkin lymphoma treatment paradigm, offering a second line treatment alternative free of transplant and high dose chemotherapy to patients who fail frontline therapy,” said Thomas Willemsen, President and CEO, Tessa Therapeutics.

Tessa Therapeutics’ Autologous and Allogeneic Cell Therapy Data to be Featured at the 17th International Conference on Malignant Lymphoma, Lugano

Retrieved on: 
Martedì, Maggio 30, 2023
Epstein–Barr virus, Nivolumab, ICML, Lymphoma, Malignancy, CHL, TT11, International Conference on Machine Learning, Patient, Poster, Therapy, CD30, ACTION, Conference, Bone marrow, Pharmaceutical industry

TT11, is Tessa’s autologous CD30.CAR-T therapy currently being investigated in combination with Nivolumab in a Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients.

Key Points: 
  • TT11, is Tessa’s autologous CD30.CAR-T therapy currently being investigated in combination with Nivolumab in a Phase 1B (ACTION) study targeting R/R classical Hodgkin Lymphoma (cHL) patients.
  • A poster providing first peak into data from this combination study will be presented at ICML, 2023.
  • TT11X, Tessa’s allogeneic “off-the-shelf” cell therapy, is based on Tessa’s proprietary CD30.CAR-modified Epstein-Barr virus-specific T-cell (EBVST) platform.
  • Details of the two presentations are as follows:
    17th International Conference on Malignant Lymphoma, Lugano

Affimed Shares Preclinical Data on AFM13’s Mechanism of Action Demonstrating Its Potential to Induce Serial Killing at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Lunedì, Aprile 17, 2023
AACR, KTH Royal Institute of Technology, ADCC, Cancer, NK, Cell, Patient, Annual general meeting, Karolinska Institute, Poster, IND, CD30, FC, Vaccine, Affimer

The preclinical data demonstrate the ability of AFM13, Affimed’s CD16A/CD30-targeting innate cell engager (ICE®), to induce serial killing of tumor cells, while preserving CD16A shedding.

Key Points: 
  • The preclinical data demonstrate the ability of AFM13, Affimed’s CD16A/CD30-targeting innate cell engager (ICE®), to induce serial killing of tumor cells, while preserving CD16A shedding.
  • The poster, shown at the Annual Meeting of the American Association for Cancer Research (AACR) in Orlando, Florida, shared results from a live-cell microchip screening with single cell resolution.
  • AFM13 increased NK killing efficiency of CD30-positive tumor cells via antibody-dependent cellular cytotoxicity (ADCC).
  • “AFM13 increased NK cell-mediated serial killing of tumor cells, even when they express low levels of CD30,” said Prof. Björn Önfelt.

Affimed Announces Presentations of Clinical Data from AFM13 Phase 2 REDIRECT and Pre-clinical Data Demonstrating CD16A Shedding Facilitates Repetitive Targeting of Tumor Cells by AFM13-armed NK Cells at the Annual Meeting of the American Association for C

Retrieved on: 
Martedì, Marzo 14, 2023
PTCL, KTH Royal Institute of Technology, Cancer, AACR, Antibody-dependent cellular cytotoxicity, Annual general meeting, Abstract, Cell, Antibody, ADCC, Patient, Karolinska Institute, Natural killer T cell, CD30, NK, Vaccine, Pharmaceutical industry

An oral presentation will show detailed results from the AFM13 REDIRECT study evaluating the treatment of patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL).

Key Points: 
  • An oral presentation will show detailed results from the AFM13 REDIRECT study evaluating the treatment of patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL).
  • In addition, a poster presentation will highlight results from the collaboration study with Prof. Björn Önfelt, further elucidating AFM13’s mechanism of action.
  • Antibody-Dependent Cellular Cytotoxicity (ADCC) is a powerful mechanism of Natural Killer (NK) cells to kill antibody-opsonized target cells.
  • However, ADCC mediated by conventional antibodies has its limitations in killing of tumor cells commonly being characterized by low tumor antigen expression.