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Interim Results of Second Phase II Trial of Telcyta In Advanced Non-Small Cell Lung Cancer Announced
PALO ALTO, Calif., June 1 /PRNewswire-FirstCall/ -- Telik, Inc. announced positive interim results from a second Phase 2 trial which confirm the clinical activity of TELCYTA™ (TLK286) administered as a single agent in the treatment of patients with non-small cell lung cancer who have failed platinum-containing regimens. The data were presented at the annual meeting of the American Society of Clinical Oncology in Chicago.
Interim results from this trial show an 8% objective response rate (one partial response by the RECIST criteria), one minor response (8%) and a 67% overall disease stabilization rate. Median duration of stable disease is greater than 4.5 months and ongoing. Median survival has not yet been reached. TELCYTA™ continues to be well-tolerated, with the most common adverse events in this trial categorized as Grade 1 or 2 (mild to moderate). There were few Grade 3 and no Grade 4 adverse events. Thirty-three patients with Stage IIIB or IV non-small cell lung cancer were evaluable for survival and 12 patients were evaluable for tumor response at the time of interim analysis. Half had failed prior platinum therapy and two-thirds also were resistant to paclitaxel.
"Advanced, chemotherapy-resistant non-small cell lung cancer patients have a predictably poor prognosis, and published clinical trials with second- and third-line agents for the disease have shown low response rates and median survival times from four to six months," said Gail L. Brown, M.D., senior vice president and chief medical officer. "In the earlier Phase 2 trial of TELCYTA™ in non-small cell lung cancer, median survival was significantly improved over that expected for these patients. We are encouraged that the objective responses and high disease stabilization rate may translate to a survival advantage in this ongoing trial."
Telik plans to initiate a registration Phase 3 trial of TELCYTA™ for the treatment of advanced non-small cell lung cancer.
In Phase 2 trials, TELCYTA™ has demonstrated clinical activity in ovarian, breast and colorectal cancer, in addition to non-small cell lung cancer. A high proportion of these tumors express GST P1-1, which activates TELCYTA™ within the tumor.
About Non-Small Cell Lung Cancer and TELCYTA™
Lung cancer results in 28% of all cancer deaths in the U.S., and it is the leading cause of cancer deaths, according to the American Cancer Society (ACS). The ACS estimates that 171,900 new cases of lung cancer, most of the non-small cell type, will be diagnosed in 2003, and an estimated 157,200 deaths will result from the disease.
TELCYTA™ is a small molecule prodrug which is activated by GST P1-1, an enzyme present in higher levels in many human cancers than in normal tissues. Upon activation, an intracellular process known as apoptosis, or programmed cell death, is initiated. TELCYTA™, which has been evaluated in clinical trials in more than 370 patients, was discovered through the application of Telik's proprietary drug discovery technology, TRAP. Telik has retained worldwide commercialization rights.