Genta Incorporated announced the release of new survival analyses based on extended follow-up of patients in a randomized phase III trial of oblimersen sodium (Genasense) for relapsed or refractory chronic lymphocytic leukemia (CLL). The new data demonstrate that patients who achieved complete remission (CR, the primary endpoint of the trial) with oblimersen plus chemotherapy have shown extended survival compared with patients whose CR was induced with chemotherapy alone. The data were presented in December at the American Society of Hematology (ASH) annual meeting in Atlanta, by Susan O'Brien, MD, professor of medicine, M.D. Anderson Cancer Center, Houston.
The new data show that the median survival of patients treated with oblimersen plus chemotherapy who achieved CR (defined as complete plus nodular partial response) has still not been reached but currently exceeds 55+ months, compared to a median of 45 months in the chemotherapy-alone group. Of 20 patients in the oblimersen group who achieved CR, 12 (60%) remain alive compared with 3 of the 8 patients who achieved CR with chemotherapy alone (38%). With a minimum follow-up of 54 months, 9 of the 12 CR patients in the oblimersen group have not required additional therapy, and 5 (25%) remain in continuous CR. In the chemotherapy-alone group, all 3 survivors who previously achieved CR have relapsed, and all have required additional antileukemic therapy.
"The addition of Genasense to chemotherapy has resulted in a clinically meaningful survival benefit for patients who achieved CR," commented Dr. O'Brien. "These data strongly confirm the high degree of clinical benefit that accrues to patients who achieve CR. Achievement of CR remains an essential goal of CLL treatment."