Genta
Incorporated announced results from its Phase 2 clinical trial using tesetaxel
as initial, single-agent chemotherapy in women with advanced breast
cancer. Tesetaxel is an oral taxane in clinical development. The trial is lead
by Memorial Sloan-Kettering Cancer Center, New York, NY, in collaboration with
three other US centers.
Women
were eligible if they had not received chemotherapy for locally advanced or
metastatic HER2-negative breast cancer. Prior adjuvant chemotherapy was allowed
if the recurrence was at least 12 months from the last dose. Forty-six patients
were accrued to the trial, and 44 are currently evaluable for response. 70% of
patients had received adjuvant chemotherapy; more than 80% of those regimens
had included an injectable taxane. More than 50% of patients had received local
radiotherapy, and approximately two-thirds had progressed on one more hormonal
therapies.
Major objective responses were
observed in 20 of 44 patients (45%), including one complete response and
nineteen partial responses. Seven of the major responders cleared more than 75%
of their measurable disease. The disease-control/clinical-benefit rate, which
includes major responders and patients with stable disease, was 82%.
Exploratory
analyses showed that 17 of 35 patients (49%) whose disease was estrogen
receptor positive (ER+) had major responses. Median progression-free survival
in the ER+ population was 7.3 months. In women with "triple-negative"
disease, which is relatively insensitive to chemotherapy, 3 of 9 patients
responded 33%.
