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Patients Treated With Oblimersen Four Times More Likely to Achieve Complete Remission Compared to Chemotherapy Alone

Genta Incorporated (NASDAQ:GNTA) announced the presentation of new analyses from the Company's randomized Phase 3 trial of Genasense(R) (oblimersen sodium) Injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In patients who were prospectively stratified as being "non- refractory," Genasense-treated patients were four times more likely to achieve complete remission compared with patients treated with chemotherapy alone. Moreover, these non-refractory patients also achieved a statistically significant increase in overall survival.

These and other analyses comprised information submitted by Genta to the U.S. Food and Drug Administration last month. Highlights of these data were presented today by Dr. Kanti R. Rai, Chief, Hematology and Oncology, North Shore/Long Island Jewish Medical Center, and Professor of Medicine, Albert Einstein College of Medicine, at the 24th Annual Symposium of the Chemotherapy Foundation in New York.

In the Phase 3 trial, 241 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 patient 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). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but exceeding 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone).

Prior to randomization on this trial, patients were prospectively stratified according to three 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. Nonetheless, clear trends were evident across all strata, which suggested the best response to Genasense was achieved in patients who had received less extensive therapy.

Patients who were protocol-defined as "non-refractory" to fludarabine comprised more than 40% of the total population. In non-refractory patients, the Genasense group compared with the chemotherapy-only group achieved:

  • A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)
  • Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.)
  • Increased overall survival (median not reached but exceeding 39+ mos. vs. 33 mos.; P = 0.05)
Similar trends were observed in the two other strata (i.e., patients who received 1-2 prior regimens, and patients whose response to last therapy was longer than 6 months).

"The Genasense Phase 3 trial met its intent-to-treat primary endpoint across the entire population of relapsed/refractory patients. However, these data clearly define a prospectively specified population that derived maximal benefit from adding Genasense to conventional chemotherapy," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer "We are pleased that FDA is taking the additional time to thoughtfully examine these and other new analyses. Together with the community of CLL physician specialists and patients, we look forward to continuing our dialog with the Agency on the pending New Drug Application in CLL."

About Genasense
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

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