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Phase III trial of hPAM4-Cide (90Y-labelled clivatuzumab tetraxetan) in pancreatic cancer terminated early due to low efficacy- Immunomedics

Read time: 1 mins
Last updated:16th Mar 2016
Published:16th Mar 2016
Source: Pharmawand

Immunomedics has announced that the Company is terminating the Phase III PANCRIT-1 trial with hPAM4-Cide (yttrium-90-labeled (90Y) clivatuzumab tetraxetan) in patients with metastatic pancreatic cancer who had received at least two prior therapies, one of which must have been a gemcitabine-containing regimen. The decision to terminate the trial early is based on the recommendation from the independent Data and Safety Monitoring Board (DSMB), following a planned interim analysis of data on overall survival (OS) after more than 50% of the required 371 deaths had occurred.

The interim analysis showed that the treatment arm of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care did not demonstrate a sufficient improvement in OS as compared to placebo plus low-dose gemcitabine and best supportive care.

Comment: Yttrium (90Y) clivatuzumab tetraxetan is a humanized monoclonal antibody designed for the treatment of pancreatic cancer. The antibody itself, clivatuzumab, is conjugated with tetraxetan, a chelator for yttrium-90, a radioisotope which destroys the tumour cells.

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