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ARIAD Pharmaceuticals, Inc.
today announced publication of
results from the Phase 1 study of ponatinib, its investigational, tyrosine
kinase inhibitor in heavily pretreated patients with resistant and refractory
chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute
lymphoblastic leukemia (Ph+ ALL). The paper was published today in the New
England Journal of Medicine (Vol. 367, No. 22, Pages 2075-88). The article is
accompanied by an editorial by John M. Goldman, D.M., F.R.C.P. of the
Department of Haematology, Imperial College London (Pages 2148-49).
The Phase 1 dose-escalation study of ponatinib enrolled 81 patients with
resistant hematologic cancers, including 60 patients with CML and five
patients with Ph+ ALL. With median follow-up at 73 weeks, 72 percent of
patients (31 of 43) with chronic-phase CML enrolled in the study had a major
cytogenetic response (MCyR), including 92 percent (11 of 12) who had the T315I
gatekeeper mutation, which is the most common mutation among resistant
patients. It was estimated that 89 percent of patients with chronic-phase CML
who had a MCyR would remain in response at 1 year (95% confidence interval,
69% to 96% by Kaplan–Meier analysis). Of 22 patients with accelerated-phase or
blast-phase CML or Ph+ ALL, 36 percent (8 of 22) had a major hematologic
response, and 32% (7 of 22) had a MCyR.
Dose-limiting toxicities reported in the study included elevated lipase or
amylase levels and pancreatitis. The most common treatment-related adverse
events included rash (32%), thrombocytopenia (27%), arthralgia (17%),
increased lipase (15%), fatigue (14%), acneiform dermatitis (14%), dry skin
(14%), and nausea (14%). Neutropenia, headache, hypertriglyceridemia and
myalgia occurred less frequently. The incidence of pancreatitis was 14% across
all dose levels in the trial. The onset of pancreatitis, elevated amylase, and
elevated lipase was dose-related with regard to both incidence and timing.
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