Seattle Genetics, Inc. SGEN today presented interim results from a
phase I clinical trial evaluating ASG-5ME for the treatment of metastatic
pancreatic ductal adenocarcinoma (PDA) at the American Society of Clinical
Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium being held January
24-26, 2013 in San Francisco, CA. ASG-5ME is an antibody-drug conjugate (ADC)
targeting the SLC44A4 antigen and is being co-developed by Seattle Genetics
and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., for the
treatment of solid tumors. The phase I data from the ASG-5ME clinical trial in
advanced pancreatic cancer identified the maximum tolerated dose (MTD) for
weekly administration, demonstrated tolerability and provided preliminary
evidence for antitumor activity.
“Pancreatic cancer is a terrible disease, with a median survival of only six
months for metastatic disease and a five-year survival rate of less than six
percent,” said Jonathan Drachman, M.D., Senior Vice President, Research and
Translational Medicine of Seattle Genetics. “There is an urgent need to
identify more effective therapeutic options for these patients, and we are
encouraged by the tolerability and evidence of antitumor activity observed in
this phase I trial. We look forward to further results from ongoing trials of
ASG-5ME in prostate and gastric cancer.”
ADCs are monoclonal antibodies that are designed to deliver cytotoxic agents
selectively to tumor cells. This approach is designed to spare non-targeted
cells and thus reduce many of the toxic effects of traditional chemotherapy
while enhancing antitumor activity. With over a decade of experience and
knowledge in ADC innovation, Seattle Genetics has developed proprietary
technology employing synthetic cytotoxic agents, such as monomethyl auristatin
E (MMAE), and stable linker systems that attach these cytotoxic agents to the
antibody. Seattle Genetics' linker systems are designed to be stable in the
bloodstream and release the cell-killing agent once inside targeted cancer
cells. ADCETRIS^® (brentuximab vedotin) is the first drug approved utilizing
Seattle Genetics' ADC technology.
A Phase I Study of ASG-5ME, a Novel Antibody-Drug Conjugate, in Pancreatic
Ductal Adenocarcinoma (Abstract #176)
A phase I clinical trial was conducted to evaluate the safety and activity and
to identify the MTD of ASG-5ME in patients with metastatic PDA. At the time of
data analysis, 35 patients with metastatic PDA were enrolled in the trial.
These patients had a median age of 63 and were heavily pretreated with a
median of three prior therapies. The median time since initial PDA diagnosis
and time since identification of metastatic disease was 1.4 years and 0.59
years, respectively. Patients received doses ranging from 0.3 milligrams per
kilogram (mg/kg) to 1.5 mg/kg administered weekly for three out of every four
weeks.
Key findings included:
* The MTD was identified as 1.2 mg/kg weekly. Of the 35 patients who
participated in the trial at the time of analysis, 18 were treated at the
MTD.
* Best response for the 18 patients treated at 1.2 mg/kg weekly included one
patient (six percent) who achieved a partial response, six patients (33
percent) with stable disease and four patients (22 percent) who had
progressive disease. Seven patients (39 percent) were not evaluable for
response.
* The most common adverse events occurring in patients at the MTD included
fatigue (50.0 percent), vomiting (44.4 percent), decreased appetite (38.9
percent), abdominal pain (33.3 percent) and nausea (33.3 percent).
* The most common Grade 3 or 4 adverse events occurring in patients at the
MTD included fatigue (27.8 percent), abdominal pain (22.2 percent),
vomiting (16.7 percent) and neutropenia (16.7 percent).
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