Celgene International Sàrl (NASDAQ: CELG) reported two REVLIMID (lenalidomide) Phase II studies, presented today at the 50th American Society of Hematology Meeting, both demonstrated high response rates and manageable side effects in patients previously untreated with symptomatic chronic lymphocytic leukemia (CLL).
The studies demonstrated greater than 90 percent disease control across all evaluable patients.
The first CLL trial, presented by Alessandra Ferrajoli, M.D., Assistant Professor of Medicine at M.D. Anderson Cancer Center in Houston, Texas had 45 patients eligible for response (at least three cycles). These patients were previously untreated, symptomatic and ≥65 years of age (median age = 71). Read New therapies changing outlook for blood cancer patients
The preliminary results from this trial demonstrated that REVLIMID induced a rapid reduction in circulating lymphocytes with a 52 percent response rate including 29 percent blood complete responses (CR) and 6 percent nodular partial responses (after cycle nine). The study demonstrated that the REVLIMID response rates improve with continued treatment. Of 33 patients that completed nine cycles of therapy, four have progressed.
CLL is a disease of the elderly with a median age of 72 at the time of diagnosis according to the U.S. National Cancer Institute. Despite elderly patients representing the largest segment living with the disease, they are generally underrepresented in clinical trials and a satisfactory frontline treatment strategy for this group has not been defined. The population in this trial is representative of the broader population in CLL.
"Based on the clinical efficacy of REVLIMID demonstrated in patients with relapsed or refractory CLL, we wanted to evaluate its efficacy and tolerability as an initial treatment for older patients, for which the best treatment strategy is unknown," said Dr. Ferrajoli. "The early results indicate that REVLIMID given as continuous therapy at a starting dose of 5 mg per day followed by slow dose escalation is active, as well as safe and well-tolerated in this patient group."
In the study, patients were eligible if they were age 65 or older and met the criteria for treatment according to the 1996 NCI-WG guidelines. All patients received REVLIMID® orally at a dose of 5 mg daily for the first 56 days. After this time, the dose could be increased by 5 mg increments every 28 days to reach a maximum dose of 25 mg daily. Allopurinol at 300 mg daily was administered from day one to 14 as a tumor lysis prophylaxis.
Side effects were manageable and the most common hematological Grade 3/4 adverse event observed in this trial was neutropenia (27%). Growth factors were not routinely used. Additionally, tumor flare reactions were observed in 46 percent of patients and most were limited to Grade 1/2 and managed with oral steroids. Tumor lysis syndrome was not observed.
The results of a separate Phase II study were presented by Christine Chen, M.D., Assistant Professor at Princess Margaret Hospital in Toronto, Canada. In this 25-patient study of patients with previously untreated CLL, utilizing a 2.5 mg starting dose of REVLIMID on days 1-21 of a 28-day cycle, Dr. Chen reported 96 percent disease control. Based on her preliminary results, there was a 56 percent partial response rate and 20 percent blood CRs. Only one patient progressed to date.
"Preliminary results from this Phase II study suggest that REVLIMID is highly active in previously untreated CLL patients," said Dr. Chen.
No cases of tumor lysis syndrome were noted, and tumor flare and myelosuppression were manageable. The most common hematological Grade 3/4 adverse events observed in this trial were neutropenia (64%) and thrombocytopenia (12%). Seven patients required intermittent granulocyte colony-stimulating factor (GCSF) support (none received routine growth factor support). Based on the data presented today, Celgene plans to open a global Phase III Registration Trial in untreated symptomatic elderly CLL patients in 2009.
Celgene initiated the REVLIMID CLL registration program in 2008. The CONTINUUMTM trial initiated in September and was reviewed by the FDA SPA procedure. This trial is studying the use of REVLIMID as a maintenance therapy for those patients who received a response through their second-line treatment. The study will be a global trial.-Celgene International Sàrl
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