FRAZER, Pa., Aug. 3 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the Journal of Clinical Oncology has published data from a pivotal phase 3 study demonstrating that TREANDA(R) (bendamustine HCl) for Injection improved clinical outcomes when compared to chlorambucil in patients with chronic lymphocytic leukemia (CLL). Results of this study were the basis of the March 2008 U.S. Food and Drug Administration (FDA) approval of TREANDA for CLL, the first agent approved by the FDA for this disease since 2001. According to the American Cancer Society, there will be more than 15,000 new cases of CLL diagnosed in 2009 alone. The study results were published online today and will also appear in the print edition later this year.
This Phase 3, randomized, international, multicenter, open-label study evaluated the efficacy and safety of TREANDA compared to chlorambucil in previously untreated patients with advanced (Binet stage B-C) CLL. Patients received TREANDA (100 mg per square meter on days 1 and 2) (n=162) or chlorambucil (0.8 mg/kg on days 1 and 15) (n=157) for up to six treatment cycles. In this study, TREANDA demonstrated significantly better outcomes for both primary endpoints compared to chlorambucil: overall response rate and progression-free survival (PFS).The overall response rate was significantly higher in patients receiving TREANDA than chlorambucil (68% vs. 31%; p<0.0001). Patients in the TREANDA treatment arm also had a higher complete response rate than those treated with chlorambucil (31% vs. 2%) which means that after treatment with TREANDA, some patients had no signs of CLL in their blood.
"CLL is the most common form of adult leukemia in the Western world. Because it is incurable, the goal of treatment is to stabilize the cancer over the long-term by extending periods of remission," said Prof. Wolfgang Knauf, Onkologische Gemeinschaftspraxis, Frankfurt, Germany and lead investigator of this study. "Treatment options are limited for those with advanced CLL, but this study shows that bendamustine demonstrates significantly better efficacy compared to chlorambucil with a tolerable safety profile."
The study also showed that patients treated with TREANDA had significantly longer PFS compared to chlorambucil (median PFS 21.6 months vs. 8.3 months; p<0.0001). TREANDA was also associated with an improvement in duration of response compared to chlorambucil (21.8 months vs. 8 months). In the study, TREANDA demonstrated a tolerable safety profile; the most common adverse events included myelosuppression, fever, nausea, vomiting and diarrhea. The Clinical Studies section of the TREANDA prescribing information includes complete FDA-approved study information.
TREANDA, a novel chemotherapy, was approved by the FDA for the treatment of CLL in March 2008. Efficacy relative to other first line therapies other than chlorambucil has not been established. TREANDA received its second approval in October 2008 for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
The following serious adverse reactions have been associated with TREANDA in clinical trials: myelosuppression, infections, infusion reactions and anaphylaxis, tumor lysis syndrome, skin reactions, and other malignancies.
TREANDA has a unique chemical structure that is synthesized to combine an alkylating group and a purine-like benzimidazole component. Though the exact mechanism of action of TREANDA remains unknown, TREANDA may act in two distinct ways to kill cancer cells. Preclinical studies suggest that TREANDA may lead to cell death by a process known as apoptosis (programmed cell death) as well as by an alternate cell death pathway which disrupts normal cell division known as mitotic catastrophe (a non-apoptotic pathway).
Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Deutschland GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited. In Germany, bendamustine is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and select Asia Pacific Rim countries.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.
Cephalon has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.
The company's proprietary products in the United States include: NUVIGIL(R) (armodafinil) Tablets [C-IV], TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV] and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
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