Genta’s Tesetaxel has demonstrated efficacy in the Phase 2b, confirmatory clinical trial, designed to evaluate the drug in patients with advanced gastric cancer.
Tesetaxel is a novel, orally absorbed taxane that has been evaluated in a completed or ongoing Phase 2a/Phase 2b clinical trials. The Phase 2b study enrolled 41 gastric cancer patients who had progressed on at least one prior chemotherapy regimen, and showed that 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.
In the study, two patient cohorts were treated over a range of doses starting at 40-45 mg (Cohort 1) and 50-60 mg (Cohort 2), whereas Cohort 3 used weight-based dosing at the maximally tolerable dose (MTD) of 27 mg/m². In Cohort 3, the overall response rate (ORR) was 20% in patients treated with Tesetaxel as 2nd-line therapy, while ORR in Cohorts 1 and 2 was 8% and 15%, respectively.
Earlier Phase 2a study with Tesetaxel reported that 14 patients achieved stable disease, with an ORR of 20% and a disease-control rate of 60%. Genta Pharmaceutical Development president and chief medical officer Loretta Itri said data from two multicenter trials support the planned Phase 3 trial of tesetaxel as 2nd-line therapy in patients with advanced gastric cancer.