- The Genasense study is the only randomized controlled trial ever
conducted in this population.
- The number, type, and severity of adverse reactions encountered with
Genasense were comparable to other leukemia drugs, which are readily
managed by specialists.
Genasense in CLL
In the pivotal Phase 3 trial, patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial - the first randomized study ever conducted in this population - achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but exceeding 36 months in the Genasense group vs. 22 months for patients treated with chemotherapy alone).
Prior to randomization on this trial, patients were prospectively stratified according to criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Clear trends, evident across all strata, suggested that the best response to Genasense occurred in patients who had received less extensive therapy. In addition to achieving the prospectively defined, intent-to-treat primary endpoint, patients in the Genasense group who were protocol-defined as "non-refractory" to fludarabine (comprising more than 40% of the total population) achieved:
- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)
- Increased time-to-progression (median = 12 months. vs. 10 months;
P = N.S.)
- Increased overall survival (median not reached but exceeding 39 months.
|SOURCE Genta Incorporated|
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