US-based biopharmaceutical firm Immunomedics (IMMU) has dosed the first patient in its Phase III registration trial of its pancreatic cancer drug, yttrium-90 (90Y)-clivatuzumab tetraxetan.
The double-blind, randomised PANcreatic Cancer RadioImmunotherapy Trial-1 (PANCRIT-1) is designed to assess the safety and efficacy of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care in patients with metastatic pancreatic cancer.
The primary endpoint of the Phase III study is overall survival (OS).
Patient's participating in the trial must have received at least two prior therapies, with one being a gemcitabine-containing regimen.
Immunomedics president and chief executive officer Cynthia Sullivan said: "If the results from the Phase Ib study are confirmed by the PANCRIT-1 trial, clivatuzumab tetraxetan could become the first antibody-directed radiation therapy approved to treat patients with solid tumours."
The PANCRIT-1 trial was designed to enrol around 440 patients with metastatic pancreatic cancer and a majority of these patients will be recruited at clinical trial sites across the US, with additional sites in Canada, Europe and Israel participating.
The company said that it is planning to complete patient accrual in the first half of 2015.
Eligible patients will be randomised two to one to the treatment arm of three doses of 90Y-clivatuzumab tetraxetan plus four doses of gemcitabine at 200mg/m2 per cycle or placebo plus low-dose gemcitabine, the company added.
All patients will be administered during the initial four weeks of each seven-week cycle, and may be repeated up to a maximum of six cycles.
The combination of 90Y-clivatuzumab tetraxetan and low-dose gemcitabine produced a median OS of four months with a manageable safety profile, in a recently completed Phase Ib clinical trial in the same patient group with relapsed pancreatic cancer.
According to the company, that was statistically significant (p = 0.021) compared with the median OS of 2.8 months when patients were treated with 90Y-clivatuzumab tetraxetan alone.
In addition, there were two partial responders in the combination arm and more importantly, the rapid enrolment of the Phase Ib trial showed an unmet medical need for treatment options for patients in this late-stage setting.
Previously, 90Y-clivatuzumab tetraxetan has received orphan drug designation in both the US and Europe, and fast-track designation in the US for the treatment of patients with pancreatic cancer.
Image: Histopathogic image of pancreatic adenocarcinoma arising in the pancreas head region. Photo: courtesy of KGH.