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.
For comments and feedback contact: editorial@rttnews.com
Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.