Dec 7 2009
Gloucester Pharmaceuticals announced today the presentation of positive
data from an analysis of ISTODAX® (romidepsin) in a subset of
patients from Gloucester’s registration study in cutaneous T-cell
lymphoma (CTCL) at the 51st American Society of Hematology
(ASH) Annual Meeting being held in New Orleans, LA. This analysis is an
assessment of patients with CTCL who—in addition to skin disease and
potential lymph node and visceral involvement—also had blood
involvement. Blood involvement is characterized as having greater than
five percent circulating Sézary (malignant) cells and is typically
associated with advanced stage, aggressive disease. ISTODAX is a member
of a new class of cancer drugs known as histone deacetylase (HDAC)
inhibitors and was recently approved by the U.S. Food and Drug
Administration for the treatment of cutaneous T-cell lymphoma in
patients who have received at least one prior systemic therapy.
“CTCL that includes blood involvement represents a major therapeutic
challenge and the results of this analysis suggest that ISTODAX may help
address a treatment void for these patients,” said Dr. Youn Kim, an
investigator in studies of ISTODAX and Professor, Department of
Dermatology and Director, Multidisciplinary Cutaneous Lymphoma Program,
Stanford Cancer Center, Stanford, CA. “In this subset of 37 patients
with blood involvement, the response rate is consistent with the
response rate from the overall population of 96 patients in the
registration trial. Additionally, the rapid and sustained reduction in
Sézary counts observed in many patients with a higher blood tumor
burden, which is typically associated with advanced stage, more
aggressive disease, is noteworthy."
The results were described in a poster presentation entitled,
“Clinically Significant Responses Achieved with Romidepsin in 37
Patients with Cutaneous T-Cell Lymphoma (CTCL) with Blood Involvement.”
Of the 96 patients enrolled in the registration study, 37 patients had
blood involvement. In this subset of patients with blood involvement> The composite assessment included
measurement of skin, lymph node and visceral involvement in addition to
measurement of circulating malignant T-cells (Sézary cells). The median
duration of response in the 37 patients with blood involvement has not
been reached; however, the current maximum duration of response is 20
months. Pruritus, intense itching, was measured in these patients
using a 100mm visual analog scale (VAS). 14 of 24 patients (58%) with
moderate to severe pruritus at baseline (≥30 mm VAS) had a clinically
meaningful decrease (≥30 mm) in VAS. The safety profile in this subset
of 37 patients was similar to the overall safety profile of ISTODAX in
the registration study which was characterized principally by mild
(grade 1 and 2) gastrointestinal disturbances, hematologic toxicities,
clinical chemistry abnormalities and asthenic conditions. The only
study-drug related serious adverse event occurring in more than one
patient was tumor lysis syndrome (2 patients).
“We’re pleased to see that the results in this subset of patients with
more challenging disease are similar to those observed overall in the
registration study,” commented Jean Nichols, President and Chief
Operating Officer of Gloucester Pharmaceuticals. “These data demonstrate
that ISTODAX has the potential to provide sustained clinical benefit to
patients with CTCL with blood involvement who have received at least one
prior systemic therapy. In addition, the observed improvements in
pruritus are encouraging because pruritus can be a particularly
troubling symptom for this patient population."
SOURCE Gloucester Pharmaceuticals
Clinical Frailty Scale can quickly predict mortality in patients with heart failure