Immunomedics Inc. announced first patient dosing in the Company's Phase III registration study of its pancreatic cancer drug, yttrium-90 ((90) Y)-clivatuzumab tetraxetan. The PANcreatic Cancer RadioImmunotherapy Trial-1 (PANCRIT-1) is a double-blind, randomized study aimed to evaluate the safety and efficacy of (90) Y-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).

In a recently completed Phase Ib clinical trial in the same patient population with relapsed pancreatic cancer, the combination of (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine produced a median OS of 4.0 months (6 of 27 subjects were alive 9 months after first dose) with a manageable safety profile. That was statistically significant (p = 0.021) compared to the median OS of 2.8 months when patients were treated with (90) Y-clivatuzumab tetraxetan alone. Additionally, there were 2 partial responders in the combination arm.

More importantly, the rapid enrollment of the Phase Ib study demonstrated an unmet medical need for treatment options for patients in this late-stage setting.