Data from Phase 3 Trial of Genasense(R) Confirm Extended Durability of Remission and Benefit in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia Monday September 19, 8:00 am ET Rolling NDA on Schedule for Completion in Fourth-Quarter 2005
BERKELEY HEIGHTS, N.J., Sept. 19 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) today announced the presentation of results from extended follow-up of patients enrolled in the Company's Phase 3 randomized trial of Genasense® (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In addition to the previously announced significant increase in major response (the trial's primary endpoint), the new data show significantly longer remission duration and significantly lower risk of relapse. The data were presented in New York at meetings of the International World Congress on CLL and also at the First Annual Meeting of the Oligonucleotide Therapeutic Society. Genta has initiated a New Drug Application for accelerated approval of Genasense in CLL. The Company has requested a meeting with the Food and Drug Administration to discuss plans for a confirmatory post-approval study.
ADVERTISEMENT 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. The trial 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%, respectively; P=0.025).
To date, 6 of the 8 patients (75%) who achieved CR/nPR with chemotherapy alone have relapsed compared with 5 of 20 patients (25%) in the Genasense treatment group. The median duration of CR/nPR was 22 months in the chemotherapy alone group; the median has not been reached in the Genasense group (P=0.03). All CR/nPR responses have been "durable" (i.e., exceeding 6 months duration).
"Extended followup has shown that most patients treated with chemotherapy alone have relapsed, whereas the remissions achieved by adding Genasense are continuing to prove quite durable," commented Dr. Kanti Rai, the trial's Principal Investigator. "These emerging differences have translated into real clinical benefit for patients."
"These new data provide important supportive evidence of the substantial clinical benefit for patients who receive Genasense in addition to standard chemotherapy for their disease," commented Dr. Loretta Itri, President and Chief Medical Officer of Genta. "The NDA submission process remains on track for completion later this year, and we look forward to our discussion with FDA regarding our Phase 4 study proposal."
Safety
Grade 3 or Grade 4 adverse events that occurred during treatment or within 30 days from last treatment in an increased percentage of patients in the Genasense group included, but were not limited to, thrombocytopenia, nausea, and intravenous-catheter complications. Adverse events resulted in discontinuation of therapy in an equal percentage of patients in both groups. Nine patients in the Genasense group and 5 patients in the chemotherapy-alone group had adverse events that resulted in death, including two patients in the Genasense group who died from complications associated with tumor lysis and "cytokine release syndrome."
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