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 Ofatumumab

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AuteurMessage
Denis
Rang: Administrateur


Nombre de messages : 15757
Date d'inscription : 23/02/2005

MessageSujet: Re: Ofatumumab   Dim 7 Aoû 2011 - 19:04

COPENHAGEN, Denmark, Aug. 5, 2011 (GLOBE NEWSWIRE) -- Genmab A/S (copenhagen:GEN) announced today top-line results from a Phase II study of ofatumumab in combination with salvage chemotherapy to treat relapsed or refractory aggressive lymphoma, including Diffuse Large B-Cell Lymphoma (DLBCL).



Genmab a annoncé aujourd'hui (le 5 aout) les résultats de l'étude de phase II pour l'ofatumumab en combinaison avec la chimiothérapie pour traiter le lymphome en rechûte ou réfractaire, incluant le "lymphome à grande cellule B diffuse" (DLBCL)

A total of 61 patients with aggressive lymphoma, who had persistent or progressive disease after first-line treatment with rituximabcombined with chemotherapy, were treated in the study. The overall response rate (ORR) was 61%. There were no unexpected safety findings. The most common grade 3 or higher adverse events were thrombocytopenia (59% of pts), anemia (36%), neutropenia (26%), lymphopenia (23%), leukopenia (18%), febrile neutropenia (13%) and hypokalemia (13%).

These data will be submitted for presentation at the 2011 Annual Meeting of the American Society of Hematology (ASH) in San Diego, US this December.

About the study

Patients in the study had previously received first line treatment with rituximab combined with standard chemotherapy. Patients received three cycles of ofatumumab in combination with ICE or DHAP salvage chemotherapy, which is used when cancer recurs or does not respond to first line treatment. The primary objective of the study was to evaluate the overall response rate of patients to ofatumumab in combination with ICE or DHAP chemotherapy according to criteria recognized by regulatory authorities known as the Revised Response Criteria for Malignant Lymphoma.

About Diffuse Large B-Cell Lymphoma

Diffuse Large B-Cell Lymphoma is a cancer of B-lymphocytes. DLBCL represents 30% of non-Hodgkin's lymphomas in adults and is the most common lymphoid malignancy in the western world. Relapsed DLBCL occurs when the cancer returns after a period of improvement. Refractory DLBCL occurs when the cancer is resistant to or does not respond to initial treatment.

About ofatumumab

Ofatumumab is a human monoclonal antibody which targets an epitope in the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is not approved in any country for treatment of relapsed or refractory DLBCL. Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.

In the United States, ofatumumab is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.

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Denis
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Nombre de messages : 15757
Date d'inscription : 23/02/2005

MessageSujet: Ofatumumab   Ven 22 Fév 2008 - 1:44

NEW YORK (Reuters Health) - Ofatumumab, a new fully human anti-CD20 monoclonal antibody, is well tolerated by patients with chronic lymphocytic leukemia (CLL) in doses up to 2,000 mg. These results of a European-American dose-escalating study support further studies on ofatumumab, according to a report in the February 1 issue of Blood.

Ofatumab, un nouvel anticorps monoclonal est bien toléré chezles patints atteints de CLL jusqu'à des doses de 2,000 mg. ces résultats proviennent d'une étude européenne/américaine sur l'ofatumumab

The open-label phase 1/2 trial was the first study of ofatumumab in relapsed or refractory patients with CLL. It was conducted at 12 centers in Europe and the United States and involved 3 cohorts, all of whom received 4 weekly infusions of ofatumumab. The 3 patients in cohort A received an initial infusion of 100 mg, followed by 3 infusions of 500 mg. The 3 patients in cohort B received an initial infusion of 300 mg, followed by 3 of 1,000 mg. The 27 patients in cohort C received a first infusion of 500 mg and three subsequent infusions of 2,000 mg.

Cette phase 1 et 2 des essais cliniques est la première sur l'ofatumab sur les patients avec CLL réfractaire.

The majority of adverse events were mild. Most (138/246, or 56%) occurred on an infusion day, and 84 were reported on the day of first infusion. Ten adverse events were serious; these included neutropenia, herpes zoster, pneumonia and hemolytic anemia. There was 1 fatality in an 82-year-old man with profound chronic hypogammaglobulinemia and infectious interstitial lung disease. Infections were reported in 51% of patients; nasopharyngitis was the most common.



The remission rate in cohort C was 50% (95% CI: 30-70%). There were no complete remissions, but 12 patients in cohort C (the highest-dose group) and 1 in cohort A had partial remissions, and 1 additional patient in cohort C had a nodular partial remission. Not all responses were sustained, however. At week 19, only 9 patients showed sustained responses.

Le taux de rémission dans la cohorte C était de 50%. Il n'y a pas eu de complètes rémissions mais 12 patients dans la cohorte C et 1 dans la cohorte A ont eu des rémissions prtielles.

The researchers caution that "this relatively small phase 1/2 study is not sufficient to definitively conclude that ofatumumab is superior" to rituximab, which is often used in progressing patients. They also note, however, that in vitro data suggest ofatumumab would be superior in relapsing CLL patients.

Les chercheurs disent que cette relativement petite étude ne suffit pas à conclure définitivement que l'ofatumumab serait supérieur à rituximab qui est souvent utilisé. Il snotent toutefois que invitro l'ofutomab serait supérieur.

Dr. Bertrand Coiffier, of the Centre Hospitalier Lyon Sud, Pierre-Benite Cedex, France, told Reuters Health he is optimistic about ofatumumab. "This antibody is different from rituximab," he explained. "It targets different epitopes from the CD20 antigen, it has different pharmacokinetics on the cell surface (longer exposition), and it has better activity on CLL cells in vitro."


Le docteur Bertrand Coiffierdu Centre hositalier de Lyon se dit optimiste.
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