Genta Incorporated announced that results from the Company's randomized Phase 3 clinical trial of Genasense(R) (oblimersen sodium) Injection in patients with relapsed or refractory multiple myeloma were presented today at the annual meeting of the American Society of Hematology (ASH) in San Diego, CA.
As previously announced, the trial did not meet its primary endpoint, which was the demonstration of a statistically significant increase in time-to-disease progression.
Patients were eligible for this trial if they had failed standard treatment for myeloma. Two hundred twenty-four patients were randomized to receive standard therapy using high-dose dexamethasone with or without Genasense. The primary objective of the study was to evaluate whether the addition of Genasense would significantly increase the time-to-progression. Secondary end-points included comparisons of objective response, clinical benefit, and safety. Experts that were blinded to treatment assignment made the final determinations of response and progression.
In the trial, 110 patients were randomized to receive Genasense plus dexamethasone, and 114 patients were randomized to receive dexamethasone alone. While randomization achieved a balance in many factors, patients randomized to the Genasense group had significantly lower performance status (P=0.02), which is a measure of general health. Patients in the Genasense group also tended to have a higher baseline measure of serum beta-2-microglobulin (P=0.08), which historically has been one of the most important markers for poor outcome. Prior to entering the study, patients in both groups had received extensive prior treatment with corticosteroids such as dexamethasone (median of 2 steroid-containing regimens).
The median time-to-progression was 3.1 months for patients treated with Genasense plus dexamethasone and 3.5 months for patients treated with dexamethasone alone, which was not significantly different (P=0.26). Sixteen patients (15%) who were treated with Genasense plus dexamethasone achieved a major clinical response (defined as a partial response or a response with greater than or equal to 75% reduction of myeloma protein), compared to 20 patients (18%) who were treated with dexamethasone alone (P=0.6).