Immunomedics reports favourable phase Ib/II pancreatic cancer study data (Pharmaceutical Business Review (PBR)) - Jan 23, 2012 - P1b/2, N=100; Treatments were well tolerated with no infusion reactions to radiolabeled clivatuzumab and few non-hematologic side effects; Hematologic suppression was transient after cycles 1 and 2
P1/2 data • Pancreatic Cancer
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Immunomedics has announced final data from Phase Ib/II study of Yttrium-90-labeled clivatuzumab tetraxetan and gemcitabine in advanced pancreatic cancer.
The data has suggested that repeated cycles of fractionated doses of clivatuzumab tetraxetan, labeled with yttrium-90 (90Y) and given in combination with gemcitabine, demonstrated therapeutic activity in pancreatic cancer patients.
In the open-label trial, 100 patients with previously untreated Stage III or IV pancreatic cancer were dosed with gemcitabine once-weekly x 4 with 90Y-clivatuzumab tetraxetan on weeks two, three and four.
Treatments were well tolerated with no infusion reactions to radiolabeled clivatuzumab and few non-hematologic side effects.Hematologic suppression was transient after cycles 1 and 2.
Immunomedics president and CEO Cynthia Sullivan said the Part II trial results continue to support the use of antibody-directed radiation therapy with 90Y-clivatuzumab tetraxetan in patients with pancreatic cancer.
"We are in discussions with FDA and opinion leaders regarding further development and eventual registration of this novel therapy modality," Sullivan added.
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