Genta Inc. (GNTA.OB) announced results from the Company's Phase 2, confirmatory, clinical trial of tesetaxel as 2nd-line treatment of patients with advanced gastric cancer.
The company said that the 2nd-line study enrolled 53 patients who had progressed on at least one prior chemotherapy regimen that included a platinum compound (cisplatin, oxaliplatin, or carboplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine [Xeloda; Hoffman-La Roche, Inc.]), or TS-1 (Taiho Pharmaceutical Co., Ltd.). Two patient cohorts (13 patients each) were treated with fixed oral doses starting at 40-45 mg (Cohort 1) and 50-60 mg (Cohort 2).
Cohort 3 (27 patients) employed the maximally tolerable starting dose of 27 mg/m2, which is the dose specified in Genta's randomized multinational trial. Doses were repeated every 3 weeks, and overall response rate (ORR) was the study's primary endpoint.
The ORR in Cohorts 1, 2 and 3 were 8%, 15% and 21%, respectively. Median survival in Cohorts 1 and 2 was 7.6 and 7.5 months, respectively, whereas median survival has not been reached in Cohort 3. Tesetaxel was generally well-tolerated. Neutropenia was the most common adverse event, followed by anemia and anorexia. There were no episodes of fever associated with neutropenia. No hypersensitivity reactions were observed.
Docetaxel (Taxotere; Sanofi, Inc.), an intravenous taxane, is approved for 1st-line treatment of advanced gastric cancer. Five studies have evaluated the activity of docetaxel as 2nd-line therapy. In these studies, the ORR ranged from 5% to 19% with median OS ranging from 3.5 to 8.4 months.
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by RTT Staff Writer
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