Genta Incorporated has announced positive results from the Phase 2b confirmatory clinical trial, designed to evaluate tesetaxel in treating patients with advanced gastric cancer.
Tesetaxel is a novel, orally absorbed taxane that has been evaluated in a broad programme of completed or ongoing Phase 2a / Phase 2b clinical trials.
The Phase 2b study included 41 patients with advanced gastric cancer who had 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).
In the study, two patient cohorts were treated over a range of 'flat' (as opposed to 'weight-based') 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.
The overall response rate (ORR) in Cohort 3 was 20% in patients treated with Tesetaxel as 2nd-line therapy, while body weight variation resulted in under-dosing relative to the MTD in Cohorts 1 and 2, which yielded ORRs of 8% and 15%, respectively.
The trial also 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.
The prior Phase 2a study randomised 35 patients with tesetaxel at starting doses ranging from 27 to 35 mg/m² once every three weeks, showing 14 patients achieved stable disease, for an ORR of 20% and a disease-control rate of 60%.
Genta Pharmaceutical Development president and chief medical officer Loretta Itri said the new data confirm the activity of tesetaxel in patients with advanced gastric cancer at levels that are at least equivalent to studies of docetaxel in the population.
"Data from two multicentre trials support the decision to undertake our planned Phase 3 trial of tesetaxel as second-line therapy in patients with advanced gastric cancer," Itri added.
The Phase 2b study demonstrated tesetaxel was well-tolerated, with the appearance of Grade 3-4 adverse events such as anemia, neutropenia and nausea.
Genta is a biopharmaceutical company, focussed on delivering innovative products for the treatment of patients with cancer.