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New Oblimersen Data Show Significantly Longer Remission Duration and Lower Risk of Relapse
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."
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."
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. Genasense has received both Orphan Drug and Fast Track designations by FDA in CLL. The Company plans to seek "Accelerated Approval" for Genasense in CLL. Accelerated Approval requires the Company to conduct a confirmatory study in CLL, and Genta plans to discuss the design of this study with FDA.
About Chronic Lymphocytic Leukemia
CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year. More than 60,000 people in the U.S. currently have CLL. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. Patients with CLL typically develop symptoms that may progress over a period of years, ultimately producing a generalized depression of immunity, marked increases in the size of spleen, liver and lymph nodes, and impaired production of other normal blood cells. Eventually, these problems may cause life-threatening complications, such as overwhelming infections and fatal bleeding. For more information about CLL, visit https://www.lls.org/.
Source: Genta Incorporated