Allos Therapeutics, Inc. (NASDAQ: ALTH) announced updated data from its ongoing dose finding Phase 1 study of FOLOTYN™ (pralatrexate injection) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). These data were showcased during an oral presentation at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA.
Data were presented on 31 patients with relapsed or refractory CTCL who received a median of 4 prior systemic therapies. The dosing regimen of 15 mg/m2 weekly for three weeks out of a four-week cycle was determined to be the optimal starting dose and schedule that provided activity with tolerability. In this dose de-escalating study, 18 patients who received FOLOTYN at the optimal dose or higher, responses were observed in 11 patients (61%). In the overall study, which included doses lower than the optimal dose, responses were observed in 12 patients (39%), including two complete responses and nine partial responses in patients who received FOLOTYN. An expansion cohort at the optimal dose of 15 mg/m2 weekly for three out of a four week cycle is actively enrolling.
"We really need new therapies for our patients with relapsed or refractory CTCL," said Steven Horwitz, M.D., assistant attending, medical oncologist, Memorial Sloan-Kettering Cancer Center, who is serving as the study chair. "We are encouraged by the responses we've seen so far. Many of these patients have had excellent responses, even at relatively low doses of pralatrexate."
About the Study
This ongoing, open-label, multi-center, dose finding, Phase 1 study is evaluating FOLOTYN in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who received at least one prior systemic therapy. The study employed a dose de-escalating strategy to determine an active, well tolerated dose and schedule of FOLOTYN in this population. To date, 31 patients with CTCL have received FOLOTYN, including 18 (58%) men and 13 (42%) women, with a median age of 57 years. Patients were randomized into various dosing regimens to determine the optimal dose and schedule.
The most common Grade 3 adverse events were stomatitis (13%). The incidence of hematological adverse events were low with thrombocytopenia (3%) and neutropenia (3%) observed in one patient. No Grade 4 adverse events were observed. The most common adverse events, any grade, were nausea (52%) and fatigue (48%).
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphomas, or CTCLs, are comprised of a number of non-Hodgkin's T-cell lymphomas, including mycosis fungoides and Sézary syndrome, which have their primary manifestations in the skin. According to the Lymphoma Research Foundation, CTCL accounts for approximately 2% to 3% of the estimated 66,000 new cases of non-Hodgkin's lymphoma diagnosed each year in the United States. According to the Cutaneous Lymphoma Foundation, the estimated annual prevalence of CTCL in the United States is between 16,000 and 20,000 cases.1
1Cutaneous Lymphoma Foundation. CTCL-MF fast facts. . Accessed December 6, 2009.
Source
Allos Therapeutics
Data were presented on 31 patients with relapsed or refractory CTCL who received a median of 4 prior systemic therapies. The dosing regimen of 15 mg/m2 weekly for three weeks out of a four-week cycle was determined to be the optimal starting dose and schedule that provided activity with tolerability. In this dose de-escalating study, 18 patients who received FOLOTYN at the optimal dose or higher, responses were observed in 11 patients (61%). In the overall study, which included doses lower than the optimal dose, responses were observed in 12 patients (39%), including two complete responses and nine partial responses in patients who received FOLOTYN. An expansion cohort at the optimal dose of 15 mg/m2 weekly for three out of a four week cycle is actively enrolling.
"We really need new therapies for our patients with relapsed or refractory CTCL," said Steven Horwitz, M.D., assistant attending, medical oncologist, Memorial Sloan-Kettering Cancer Center, who is serving as the study chair. "We are encouraged by the responses we've seen so far. Many of these patients have had excellent responses, even at relatively low doses of pralatrexate."
About the Study
This ongoing, open-label, multi-center, dose finding, Phase 1 study is evaluating FOLOTYN in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who received at least one prior systemic therapy. The study employed a dose de-escalating strategy to determine an active, well tolerated dose and schedule of FOLOTYN in this population. To date, 31 patients with CTCL have received FOLOTYN, including 18 (58%) men and 13 (42%) women, with a median age of 57 years. Patients were randomized into various dosing regimens to determine the optimal dose and schedule.
The most common Grade 3 adverse events were stomatitis (13%). The incidence of hematological adverse events were low with thrombocytopenia (3%) and neutropenia (3%) observed in one patient. No Grade 4 adverse events were observed. The most common adverse events, any grade, were nausea (52%) and fatigue (48%).
About Cutaneous T-Cell Lymphoma
Cutaneous T-cell lymphomas, or CTCLs, are comprised of a number of non-Hodgkin's T-cell lymphomas, including mycosis fungoides and Sézary syndrome, which have their primary manifestations in the skin. According to the Lymphoma Research Foundation, CTCL accounts for approximately 2% to 3% of the estimated 66,000 new cases of non-Hodgkin's lymphoma diagnosed each year in the United States. According to the Cutaneous Lymphoma Foundation, the estimated annual prevalence of CTCL in the United States is between 16,000 and 20,000 cases.1
1Cutaneous Lymphoma Foundation. CTCL-MF fast facts. . Accessed December 6, 2009.
Source
Allos Therapeutics
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