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Aeterna Zentaris: Final Phase 2 Data Demonstrate Perifosine and Sorafenib Combination Therapy Well Tolerated by Heavily Pretreated Lymphoma Patients
Promising clinical response activity observed in patients with Hodgkin lymphoma QU&#x...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nPromising clinical response activity observed in patients with Hodgkin\n lymphoma\n\n\nQUÉBEC CITY, Dec. 11, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) today announced that final Phase 2 data demonstrated\n that the combination of perifosine, its oral AKT inhibitor, and\n sorafenib, was well tolerated by heavily pretreated patients with\n relapsed/refractory lymphomas. Furthermore, promising clinical response\n activity was observed in patients with classical Hodgkin Lymphoma\n (\"HL\"), suggesting that this subgroup could represent the target\n population for future studies. Data were presented yesterday by Anna\n Guidetti, MD, of the Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy, during a poster session at the American Society of\n Hematology annual meeting in Atlanta, Georgia.\n\n\nThe Study\n\n\nThis investigator-driven Phase 2 trial sponsored by the Fondazione IRCCS Istituto Nazionale Tumori, involved 40 patients with relapsed/refractory lymphomas who had failed\n second or subsequent-line salvage chemotherapy: there were 3 patients\n with diffuse large B-cell lymphoma, 3 with follicular lymphoma, 1 with\n Waldenstrom macroglobulinemia, 8 with chronic lymphocytic leukemia\n (\"CLL\") and 25 with classical Hodgkin lymphoma (\"HL\"). At study entry,\n 12 patients (30%) had relapsed and 28 (70%) refractory disease.\n Treatment plan included an initial 4 week treatment with perifosine (50\n mg BID, per os) to assess tolerability and tumor response.\n Subsequently, patients achieving less than partial response (\"PR\") were\n given perifosine (50 mg BID, per os) combined with sorafenib (400 mg\n BID, per os) until progression of disease (\"PD\") or significant\n clinical toxicity. Patients achieving at least a PR went off-study and\n continued with perifosine (50 mg BID, per os) alone until PD or\n clinical toxicity. Tumor response was assessed according to the revised\n response criteria for malignant lymphoma of the International Working\n Group.\n\n\nResults\n\n\nBased on tumor response to the initial 4 week perifosine therapy, 36 of\n 40 patients who achieved less than PR were subsequently administered\n the perifosine/sorafenib combination therapy. Median duration of\n combination therapy was 4 months (range: 2-18). Four CLL patients who\n achieved at least a PR wi...