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Phase 3 Trial of Genasense in Advanced Melanoma Updated
AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from Genta’s prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy and who are identified by a biomarker (low-normal levels of lactate dehydrogenase [LDH]). The co-primary endpoints of AGENDA are progression-free survival (PFS) and overall survival. The trial is being led by the EADO in Europe and by the M.D. Anderson Cancer Center, Houston, TX in the U.S.
To date, more than three-quarters of the expected total number of 300 patients have been randomized into AGENDA. A total of 77 sites in 12 countries are open in Europe, the U.S., Canada, and Australia. As shown in the tables below, updated preliminary information on patient characteristics and safety findings in approximately two-thirds of patients accrued to AGENDA are similar to those in the biomarker-defined population that was accrued in the previous Phase 3 trial of Genasense, known as GM301. The incidence of serious adverse events (SAEs) in AGENDA has been somewhat lower, which may reflect the double-blind design of AGENDA compared with the open-label design of GM301.
“We have made very substantial progress in accrual and have noted similar patient demographics in the completed and ongoing trials”, said Dr. Loretta M. Itri, Genta’s President Pharmaceutical Development, and Chief Medical Officer. “Overall data from patients in these two populations, who are not identified as to treatment assignment, also show good congruence to date for the number and timing of progression events, which are key components in the PFS co-primary endpoint. We are grateful for the excellent support we have received from the investigator community and look forward to the timely completion of target accrual later this quarter.”
AGENDA is a global Phase 3, randomized, double-blind trial in patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from an antecedent randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy (GM301). AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood.
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
Source: Genta Incorporated