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ASCO: Temodar (Temozolomide) Promising For A Variety of Cancers SAN FRANCISCO, CA -- May 15, 2001 -- Schering-Plough Research Institute today reported results of several investigational studies evaluating Temodar® (temozolomide) Capsules in a variety of cancers. A total of 36 study abstracts involving Temodar were presented here at the 37th annual meeting of the American Society of Clinical Oncology (ASCO). "While the results of these studies are preliminary, we are very encouraged by these findings as they pertain to several very aggressive cancers," said Jean-Jacques Garaud, M.D., executive vice president of worldwide clinical research and clinical operations, Schering-Plough Research Institute. "Ongoing studies are being conducted to further evaluate Temodar in these cancers." The U.S. Food and Drug Administration (FDA) in 1999 granted accelerated approval to Temodar for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine. This response is based on the response rate in the indicated population. No results are available from randomized controlled trials in recurrent anaplastic astrocytoma that demonstrate clinical benefit resulting from treatment, such as improvement in disease-related symptoms, delayed disease progression or improved survival. Temodar is the first new chemotherapy agent for this type of brain tumor approved in the United States in 20 years. Temozolomide, an oral cytotoxic agent, is a second-generation imidazotetrazine alkylating agent. Cytotoxic therapies are designed to prevent the replication of cells that divide rapidly, including those in tumors. Schering-Plough has exclusive worldwide rights to market temozolomide through a licensing agreement with Cancer Research Campaign Technology, Ltd., of the United Kingdom. For the patients with anaplastic astrocytoma studied using Temodar, myelosuppression (thrombocytopenia) was the dose-limiting adverse event. The effect usually occurred within the first few cycles of therapy, was not cumulative and was resolved within 14 days. Hospitalization, blood transfusion and discontinuation of therapy due to myelosuppression occurred in less than 10 percent of patients treated with temozolomide. The most common side effects were nausea (53 percent), vomiting (42 percent), headache (41 percent), fatigue (34 percent) and constipation (33 percent), each of which were severe in 10 percent or less of patients. Nausea and vomiting were readily controlled by standard antiemetic therapy prior to dosing. Abstracts were presented at ASCO regarding the investigation of temozolomide in the treatment of oligodendrogliomas, low-grade gliomas and newly diagnosed glioblastoma multiforme. In addition, the results of studies using new administration schedules were reported. Metastatic brain tumors occur at some point in 20 percent to 40 percent of people with cancer. The incidence of metastatic brain tumors has been increasing as cancer patients live longer. "Research into improving existing treatments or developing new treatments is vital in order to provide patients with as many options as possible to fight this devastating disease," said Robert Tufel, MSW, MPH, director of patient services at the National Brain Tumor Foundation. Two Phase II clinical studies in brain metastases presented at ASCO examined the safety and activity of temozolomide in conjunction with and adjuvant to radiotherapy. Radiotherapy has been the most effective treatment of metastatic brain tumors to date. Ongoing studies are evaluating the potential of temozolomide as a viable adjunct to radiotherapy in the treatment of brain metastases. Metastatic melanoma is the most serious and life-threatening form of skin cancer, accounting for only about 5 percent of skin cancers but causing approximately 75 to 85 percent of skin-cancer-related deaths. Results of a Phase I trial investigating escalating doses of temozolomide plus thalidomide as combination therapy were presented at ASCO. Thalidomide is a biologic response modifier that influences several cellular activities that may be important in controlling metastatic melanoma. Also reported were results of a Phase II trial of a biochemotherapy regimen including temozolomide in combination with interferon alfa-2b, cisplatin, vinblastine and interleukin-2. Almost all patients with non-small cell lung cancer (NSCLC) suffer relapses, making investigation into salvage therapies for previously treated patients crucial. Researchers presented preliminary results of an ongoing Phase II study of an investigative schedule of temozolomide in patients with previously treated, advanced, incurable NSCLC. Acute leukemia is characterized by rapid and abnormal proliferation of leukocytes (white blood cells) in the bone marrow, spleen and lymph nodes. Investigators presented preliminary results of a Phase I study of temozolomide as a potential alternative to intensive chemotherapy in patients with refractory and relapsed acute leukemia. Cancer is often treated with multiple modalities. The rationale for combination therapy with two or more agents is to produce an additive or synergistic effect by using drugs with different mechanisms of action. Preclinical studies reported at ASCO included temozolomide in combination with CPT-11 (irinotecan), VP-16 (etoposide), topotecan, cisplatin, gemcitabine, vinorelbine, paclitaxel and thalidomide. SOURCE: Schering-Plough Research Institute E-mail this page to a friend or colleague! To print, use this version