Activity of tesetaxel in advanced gastric cancer confirmed

US antisense technology-based drug developer Genta (OTCBB: GNTA.OB) has announced positive results from its Phase IIb, confirmatory clinical trial of tesetaxel in patients with advanced gastric cancer.

The study has enrolled 41 patients who progressed on at least one prior chemotherapy regimen that included a platinum compound (cisplatin, oxaliplatin or carboplatin) and a fluoropyrimidine compound (5-fluorouracil [5-FU] or capecitabine [Roche’s Xeloda]).. Two patient cohorts were treated over a range of "flat" (as opposed to "weight-based") doses starting at 40-45mg (Cohort 1) and 50-60mg (Cohort 2), whereas Cohort 3 used weight-based dosing at the maximally tolerable dose (MTD) of 27 mg/m2. Doses were repeated every 3 weeks, and overall response rate (ORR) was the trial's primary endpoint.

The ORR in Cohort 3, which remains open to accrual, was 20% in patients treated with tesetaxel as second-line therapy. Body weight variation resulted in under-dosing relative to the MTD in Cohorts 1 and 2, which yielded ORRs of 8% and 15%, respectively. Median survival has not been reached in Cohort 3, whereas median survival in Cohorts 1 and 2 was 7.6 and 7.5 months, respectively. Overall survival (OS) is the primary endpoint in planned Phase III studies of tesetaxel in gastric cancer.