Faeth reports phase 2 trial results for endometrial cancer drug

Austin, Texas - Faeth Therapeutics (FTH) has released results from a phase 2 trial investigating PIKTOR, a potential drug combination for advanced endometrioid endometrial cancer. The trial, conducted in collaboration with The GOG Foundation, enrolled 42 patients with the specific cancer type and a key genetic mutation. Of these, 12 out of 36 efficacy-evaluable patients achieved confirmed objective responses, indicating a 33% overall response rate.

Among patients with the PIK3CA mutation, the response rate was even higher at 44%, or 7 of 16 patients. The disease control rate achieved 83% success. The estimated median progression-free survival was 7.4 months, with 62% of patients surviving without progression for at least 6 months. At the data cutoff, 16 patients continued treatment.

Most patients (98%) had undergone prior taxane-based chemotherapy and immunotherapy. Sixty percent had distant metastases, and 48% had diabetes or pre-diabetes. Approximately 5% of patients stopped treatment due to treatment-related side effects, with 12% experiencing hyperglycemia and 2% experiencing grade 3 stomach issues. The company plans to move forward with a phase 3 trial, pending regulatory approval.