Study Reports 92 Percent Response Rate to Combination Treatment
FRAZER, Pa., July 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) announced today that in a phase 2 study published online today in the Journal of Clinical Oncology, 92 percent of patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma (NHL) responded to treatment with TREANDA(R) (bendamustine hydrochloride) for Injection plus rituximab. This combination study is one of three studies in patients with NHL that Cephalon submitted in December 2007 to the U.S. Food and Drug Administration requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. TREANDA was approved by the FDA in March 2008 for the treatment of patients with chronic lymphocytic leukemia and is not currently approved for use in NHL.
"A variety of treatment options have been employed in patients with indolent B-cell and mantle cell lymphomas, but resistance to treatment in this patient population often limits effective therapeutic options," said Dr. Charles Morris, Vice President, Worldwide Clinical Research at Cephalon. "Based on what we saw in this study, the combination of TREANDA with rituximab appears to elicit a high rate of durable responses and encouraging progression-free survival."
About the Study
In this multi-center, open-label, single arm, Phase 2 study, 66 patients with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab therapy were treated. Patients received rituximab 375 mg/meter squared intravenously on day one and TREANDA 90 mg/meter squared intravenously on days two and three of a 28-day cycle for up to six cycles. An additional dose of rituximab was given one week before the first cycle and four weeks after the last cycle.
Overall response rate was 92 percent with a complete response rate (CR) of 41 percent. A CR means that after treatment with the TREANDA and rituximab combination, patients had no detectable evidence of disease. These responses were durable, with a median duration of 21 months overall (19 months for the mantle cell population). Additionally, the combination of TREANDA and rituximab was associated with progression-free survival (PFS) of 23 months overall and for patients with mantle cell lymphoma.
In this published study, the combination of both treatments was generally well tolerated. The most common adverse events in the trial included myelosuppression (a condition in which bone marrow activity is decreased), nausea, infection, fatigue, constipation, and diarrhea.
This combination study is one of three studies in patients with NHL that Cephalon submitted to the FDA in December 2007 requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. The other two studies evaluated the efficacy and safety of TREANDA as monotherapy in this patient population. In all three studies, patients treated with TREANDA had a high rate of response and a manageable side effect profile, with myelosuppression as the most common side effect. Cephalon anticipates a review decision on this application by the agency by October 31, 2008.
About Non-Hodgkin's Lymphoma
According to the American Cancer Society, an estimated 66,000 people in the United States will be diagnosed in 2008 with NHL. There are approximately 30 different types of NHL, which have been divided into two major categories: indolent (or slow growing) and aggressive. Indolent B-cell lymphoma and mantle cell lymphoma (one of the more aggressive sub-types) are difficult to treat because patients are prone to relapse after treatment.
TREANDA has a unique chemical structure with two primary components, an alkylating group and a benzimidazole component. Preclinical data suggest that TREANDA can lead to cell death via several pathways. TREANDA damages the DNA in cancer cells, which leads to cell death by a process known as apoptosis (programmed cell death) and potentially by an alternate cell death (non-apoptotic) pathway known as mitotic catastrophe (a disruption of normal cell division). The exact mechanism of action of TREANDA remains unknown.
Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas' licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN(R). In Germany, RIBOMUSTIN 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 selected Asia Pacific Rim countries.
About Cephalon Oncology
Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds. In addition to TREANDA, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX(R) (arsenic trioxide) injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.
In Europe, Cephalon markets two additional oncology products: Myocet(R) (liposomal doxorubicin), indicated in combination with cyclophospamide for the first-line treatment of metastatic breast cancer and Targretin(R) (bexarotene) a treatment for advanced cutaneous T-cell lymphoma.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, 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. The company's European headquarters are located in Maisons-Alfort, France.
The company's proprietary products in the United States include: PROVIGIL(R) (modafinil) Tablets [C-IV], FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, TREANDA, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL(R) (naltrexone for extended-release injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(TM) (armodafinil) 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, including the results of any clinical programs with respect to TREANDA or the timing or approval of any current or future filings for regulatory approval of TREANDA or other Cephalon Oncology compounds; interpretation of clinical results, particularly with respect to the TREANDA clinical trials; 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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