Immunomedics Begins Dosing in Pancreatic Cancer Trial

Immunomedics has dosed the first patient in its Phase III registration study of its pancreatic cancer drug, yttrium-90 (90Y)-clivatuzumab tetraxetan. Clivatuzumab tetraxetan contains a humanized, highly specific antibody that targets a mucin antigen found on pancreatic cancer cells, and is conjugated to a linker that facilitates complexing with radiometals.

 

The PANcreatic Cancer RadioImmunotherapy Trial-1 (PANCRIT-1) is a double-blind, randomized study aimed to evaluate the safety and efficacy of 90Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care in patients with metastatic pancreatic cancer who have received at least two prior therapies, one of which must have been a gemcitabine-containing regimen. The primary endpoint of this study is overall survival (OS).

 

The company recently completed a Phase Ib trial in the same patient population with relapsed pancreatic cancer in which the combination of 90Y-clivatuzumab tetraxetan and low-dose gemcitabine produced a median OS of 4.0 months (six of 27 subjects were alive nine months after first dose) with a manageable safety profile. That was statistically significant compared to the median OS of 2.8 months when patients were treated with 90Y-clivatuzumab tetraxetan alone. Additionally, there were two partial responders in the combination arm.

 

The PANCRIT-1 trial will enroll approximately 440 patients with metastatic pancreatic cancer. A majority of these patients will be recruited at clinical trial sites across the U.S., with additional sites in Canada, Europe and Israel. Eligible patients will be randomized 2:1 to the treatment arm of three doses of 90Y-clivatuzumab tetraxetan plus 4 doses of gemcitabine at 200 mg/m2 per cycle or placebo plus low-dose gemcitabine. All patients will receive best supportive care. Treatments are administered during the initial four weeks of each seven-week cycle, and may be repeated up to a maximum of 6 cycles. The company plans to complete patient accrual in 1H15.