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Release from Immunomedics Shows Updated Results from 90Y-Clivatuzumab Tetraxetan, Overall Survival of 7.9 Mos. Receiving Multiple Cycles

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Immunomedics, Inc. (Nasdaq: IMMU) today announced that patients receiving multiple cycles of the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (^90Y), in combination with low-dose gemcitabine, had increased survival advantage.

Vincent J. Picozzi Jr., M.D., Director of the Pancreas Center of Excellence at the Virginia Mason Medical Center's Digestive Disease Institute, Seattle, WA, presented the updated Phase Ib study at a press conference hosted by AACR at its special conference on Pancreatic Cancer. This is one of only 3 studies that have been selected by AACR to participate in the media outreach program. The full poster presentation will occur on Tuesday, May 20, 2014 from 12:30-3:00 p.m. Central Time.

"We found that ^90Y-clivatuzumab tetraxetan, when used with low-dose gemcitabine, is a safe, low-side effect therapy that can prolong survival for at least some patients with metastatic pancreatic cancer, even when no chemotherapy options exist," remarked Dr. Picozzi. "Our studies imply that radiolabeled antibodies are safe to use in advanced pancreatic cancer, and that it may be possible to attach other anticancer agents besides ^90Y to clivatuzumab tetraxetan to fight pancreatic cancer," he added.

A total of 58 patients with pancreatic cancer who had received two or more prior therapies were enrolled in this multicenter study. Twenty-nine patients received the combination of ^90Y-labeled-clivatuzumab tetraxetan once-a-week for 3 weeks and gemcitabine given weekly for 4 weeks (Arm A) while another group of 29 patients were administered 4 doses of ^90Y-labeled-clivatuzumab tetraxetan alone (Arm B). This treatment cycle was repeated every 4 weeks until unacceptable toxicity, patient deterioration or patient withdrawal. Twenty-three patients completed more than one cycle of treatment, with 12 patients in Arm A and 11 in Arm B.

Notwithstanding the late-stage setting with a difficult-to-treat cancer, patients in Arm A had a median overall survival (OS) of 7.9 months, which was statistically significant (p = 0.004) over the median OS of 3.4 months in patients treated repeatedly with the radiolabeled antibody alone (Arm B). Additionally, 2 patients in Arm A had a partial response and 2 patients are still alive 13 and 15 months after the start of their combination treatment.

The only clinically significant side effect was reduction in blood counts, especially platelets, which was transient and manageable.

"We have launched the Phase III PANCRIT-1 registration trial to confirm these encouraging results," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We plan to complete patient accrual by the middle of 2015, with top-line results expected in the first half of 2016," Ms. Sullivan added.

Posted-In: News FDA Press Releases


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