Treanda Effective In Indolent Non-Hodgkin's Lymphoma Trial

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Main Category: Clinical Trials / Drug Trials
Also Included In: Blood / Hematology;  Cancer / Oncology
Article Date: 11 Dec 2007 - 3:00 PDT

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Drug company Cephalon Inc announced yesterday, 10th December, that a pivotal study found its experimental chemotherapy drug Treanda (bendamustine) was effective in treating patients with indolent non-Hodgkin's lymphoma (NHL), whose disease has progressed during or after treatment with rituximab.

The announcement was made in a press release coinciding with the presentation of clinical trial results at the 49th Annual Meeting of the American Society of Hematology (ASH) in Atlanta Georgia.

The National Cancer Institute estimates that 30,000 Americans will be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer that affects the lymphatic system. Patients are prone to relapse after treatment, making this cancer one of the most difficult to treat.

Dr Brad Kahl, lead investigator of the study, and Associate Professor, Director Lymphoma Service, University of Wisconsin Paul P Carbone Comprehensive Cancer Center, said that:

"The high response rate in this study suggest that bendamustine [Treanda] could offer substantial periods of remission to patients with indolent NHL whose cancer is progressing after treatment with rituximab."

"Because many patients with NHL eventually become resistant to treatment with rituximab and other therapies, new treatments are always required," he explained.

The investigators recruited 100 patients whose indolent NHL disease had progressed during or after treatment with rituximab, or a treatment containing rituximab.

Patients were given 120 mg per metre squared of drug over 60 minutes intravenously on day 1 and day 2 of a 21 day cycle, 6 times, and in some discretionary cases, up to 8 cycles were administered.

The patients' response were assessed by an independent radiological committee, and the results showed that 75 of them were responsive, of whom 14 had a confirmed complete response while a further 3 had an unconfirmed complete response.

The median length of a response period was 9.2 months and the drug also showed a manageable level of tolerability, said the investigators.

Adverse events were in line with what is expected in chemotherapy and included: fever, vomiting, nausea, fatigue, diarrhea, and myelosuppression (bone marrow suppression, stops production of certain immune system blood cells). The most common serious adverse events were febrile neutropenia (caused by low levels of some white blood cell types) and pneumonia.

Executive Vice President of Worldwide Medical and Regulatory Operations at Cephalon, Dr Lesley Russell, said:

"The data presented at ASH, as well as from other studies using bendamustine, gives us great optimism that Treanda may have an important role to play in the treatment of NHL, chronic lymphocytic leukemia (CLL) and other cancers."

Treanda (bendamustine) works in two different ways to kill off cancer cells. First it damages the DNA of cancer cells which leads to programmed cell death (apoptosis), and secondly it disrupts normal cell division via a pathway called mitotic catastrophe.

Click here for American Society of Hematology.

Written by: Catharine Paddock


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