Final report of Genasense Phase 3 trial in melanoma
Genta Incorporated announced that results of the Company's Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma were published on-line in the Journal of Clinical oncology. The paper is accompanied by an editorial that discusses the trial's results in the context of current options for melanoma treatment. The extended follow-up data from this publication form the basis of a Marketing Authorization Application (MAA) that is currently pending review by the European Medicines Agency (EMEA).
Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. A summary of the data from the final analysis appears below.
The report is based on long-term data derived from the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In this trial, which was conducted at 139 sites in 9 countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The paper includes data from a prospectively defined analysis that evaluated 24-months of minimum follow-up on all patients. Unless otherwise noted, these results were based on an intent-to-treat analysis:
Overall response: Genasense/DTIC 13.5%; DTIC 7.5%; P 0.007
Complete response: Genasense/DTIC 2.8%; DTIC 0.8%; P 0.03
Durable response: Genasense/DTIC 7.3%; DTIC 3.6%; P 0.03
Progression-free survival, median: Genasense/DTIC 2.6 mos.; DTIC 1.6 mos.; P 0.0007
Overall survival, median: Genasense/DTIC 9.0 mos.; DTIC 7.8 mos.; P 0.077
Prior to randomization, patients were prospectively stratified according to certain risk factors, including elevated blood levels of an enzyme known as LDH - a factor that previous clinical studies have shown is strongly associated with poor outcome. The final analysis has shown that LDH was the sole stratification factor significantly associated with a treatment interaction. When this treatment effect was evaluated, the efficacy of Genasense was significantly superior for all major efficacy outcomes in patients who had normal LDH at baseline, a group that comprised approximately two-thirds of patients in the trial (N=508).
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