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Hycamtin Achieves Promising Results In Patients With Small Cell Lung
Cancer
Genova, Italy, April 30, 1997 -- Hycamtin (topotecan hydrochloride for injection, SmithKline Beecham) may offer a promising new treatment option for patients suffering from small cell lung cancer, one of the most lethal cancers in the United States, according to a study published in the May issue of the Journal of Clinical Oncology. In one of the largest phase II trials to date conducted with a single agent in the second-line treatment of this disease, patients treated with Hycamtin achieved a 22 percent response rate. These findings may offer new hope for the estimated 45,000 patients who will be diagnosed with small cell lung cancer this year. Hycamtin is currently available for use in the treatment of patients with recurrent, metastatic ovarian cancer.
“This is one of the highest response rates ever reported with a single agent in small cell lung cancer patients who had previously undergone and failed combination chemotherapy with traditionally used drugs. Since results of studies with other drugs as second-line treatment have been very disappointing, there is currently no standard treatment for this patient population. Hycamtin is one of the few drugs in the past ten years to demonstrate significant activity in treating this devastating disease. This efficacy in previously treated patients may be due to its novel mechanism of action that is completely different from that of currently-used agents,” said Andrea Ardizzoni, M.D., Department of Medical Oncology, National Cancer Institute, Genova, Italy and lead investigator.
Hycamtin Shows Promising Results in Multicenter Trial
In this non-comparative, multicenter study involving 22 European institutions, 101 patients with small cell lung cancer were administered a 30-minute infusion of Hycamtin 1.5 mg/m as a single agent therapy for five consecutive days every three weeks. All patients had received prior treatment with other anti-tumor agents.
Nearly one quarter of all eligible patients treated with Hycamtin achieved a complete or partial response. The overall response rate was 22 percent [6.4 percent in refractory patients (patients who never responded to initial treatment) and 37.8 percent in patients sensitive to first-line chemotherapy (patients who responded to initial treatment and then worsened)]. The median survival time for patients who responded to Hycamtin was 12.5 months, and the median survival time for all patients was 5.4 months.
In May, 1996, Hycamtin was the first topoisomerase I inhibitor to be cleared for marketing by the U.S. Food and Drug Administration and is indicated for the treatment of patients with recurrent, metastatic ovarian cancer. Hycamtin is also cleared for second-line treatment of ovarian cancer in 15 European Union (EU) member countries and is under review with regulatory authorities in other major markets around the world. This new class of drugs kills cancer cells by inhibiting the enzyme topoisomerase I, an enzyme which is essential in the replication of DNA in cancer cells. Hycamtin has been studied in over 200 clinical trials and is currently under clinical investigation for a number of other cancers including small cell and non-small cell lung, breast and colorectal cancers, acute and chronic leukemia, as well as first-line combination chemotherapy in patients with ovarian cancer.
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