Immunomedics, Inc. 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.
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