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| |  Hycamtim Promising in Advanced Squamous Cell Lung Cancer Denver, CO, May 21, 1997 -- According to a study presented at the 33rd annual meeting of the American Society of Clinical Oncology (ASCO), Hycamtin (topotecan hydrochloride for injection) may offer a promising new treatment option for patients suffering from advanced squamous cell lung cancer, a subtype of non-small cell lung cancer. Patients with advanced squamous cell lung cancer who were treated with Hycamtin as first-line therapy achieved a 23 percent response rate. To date, there is no standard treatment for non-small cell lung cancer, one of the most common and lethal cancers which affects an estimated 135,000 Americans each year. Hycamtin, from SmithKline Beecham, is currently indicated for use in the treatment of patients with recurrent, metastatic ovarian cancer. "The results of this study are encouraging, since advanced non-small cell lung cancer is very difficult to treat and has proven to be extremely resistant to chemotherapyagents," said Roman Perez-Soler, M.D., lead investigator, associate professor of medicine, deputy chairman, department of thoracic/head and neck medical oncology, The University of Texas, M.D. Anderson Cancer Center in Houston, Texas. “In the past, few single agent therapies have achieved response rates greater than 15 percent. The results we observed with topotecan may be attributable to the drug's unique mechanism of action that is different from that of currently-used.” Hycamtin Shows Promising Results In Trial In this non-comparative Phase II trial, 30 patients (24 males and 6 females) with advanced (stage IIIB or IV) squamous cell lung cancer were treated with Hycamtin 1.5 mg/m2 for five days every 21 days. None of the patients had received prior chemotherapy. The overall objective response rate was 23 percent. Seven patients (23.3 percent) achieved a partial remission (tumor shrinkage of greater than 50 percent) and two patients achieved a minor response (6.7 percent). The overall median survival for all evaluable patients was 44 weeks. In May, 1996, Hycamtin was the first topoisomerase I inhibitor to be cleared for marketing by the U.S. Food and Drug Administration (FDA) and is indicated for the treatment of patients with recurrent, metastatic ovarian cancer. 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 cancers including small cell and non-small cell lung, breast and colorectal cancers, leukemias and lymphomas, as well as first-line combination chemotherapy in patients with ovarian cancer.
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