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Patients with Advanced Pancreatic Cancer Respond Combination Chemotherapy and IMC-C225

Patients with Advanced Pancreatic Cancer Respond Combination Chemotherapy and IMC-C225
M. D. Anderson News Release 05/13/01

In an interim report of a national Phase II trial led by The University of Texas M. D. Anderson Cancer Center, a combination of a new biological agent with standard chemotherapy is showing some positive response in patients with advanced pancreatic cancer.

Dr. James Abbruzzese, lead investigator for the study and chairman of the Department of Gastrointestinal Medical Oncology at M. D. Anderson, presented the data at the 37th annual meeting of the American Society of Clinical Oncology in San Francisco. 

Of the 40 patients with advanced pancreatic cancer, five patients (12.5 percent), showed a partial response to the combination of the new monoclonal antibody, IMC-C225, with the chemotherapy agent, gemcitabine.  In addition, 16 patients (39 percent) who received the combination had disease that stabilized or had a minor response.

"Cancer of the pancreas is a devastating disease.  It is one in which gemcitabine, the standard chemotherapy for treatment of this cancer, produces a response rate of less than 10 percent," said Dr. Abbruzzese. "This study suggests that patients who receive chemotherapy with IMC-C225 benefit from the addition of this targeted therapeutic agent."

Dr. Abbruzzese noted that Phase III trial will be needed to demonstrate how IMC-C225
and chemotherapy will affect long-term survival. 

"Thus far, it is an encouraging combination of a less-toxic, specifically-targeted agent combined with a more toxic drug that affects not only cancer cells, but healthy cells as well," he said.

In the study, when the gemcitabine was combined with IMC-C225 and compared with prior studies of gemcitabine, overall survival at one year was 32.5 percent compared to only 18 percent with gemcitabine alone.  Median survival was 202.5 days for the combination compared with 169.5 days for the chemotherapy alone. Progression-free survival at one year was 17.5 percent for the combination, compared to nine percent for the chemotherapy only, reported Dr. Abbruzzese.

The most common adverse reactions reported during the study using gemcitabine and IMC-C225 were nausea, fatigue and an acne-like rash.

Dr. Abbruzzese said cancer of the pancreas is similar in molecular structure to cancers of the colon, esophagus, cervix, prostate, ovaries, kidneys, lungs and head and neck in that there are a high number of epidermal growth factor (EGF) receptors on the surface of the cancer cells.  IMC-C225 targets the EGF receptors, possibly altering their resistance to chemotherapy and breaking down the cancer cells' ability to grow. Of the 54 patients screened for this study, more than 90 percent of them tested positive for EGFr expression.

"This new molecular approach to pancreatic cancer is an exciting one, but the vital next step is to conduct a Phase III trial," said Dr. Abbruzzese. "The results of such a trial will tell us if we can have a measurable impact on a devastating disease."

Dr. Abbruzzese cautions patients with pancreatic cancer to remain on their standard course of treatment.  He emphasized that researchers' focus now is strictly to learn if the drug is effective in a much larger group of patients.  A Phase III trial is currently being planned.

IMC-C225 is licensed and manufactured by ImClone Systems, Inc.  Dr. John Mendelsohn, president of M. D. Anderson and a member of ImClone's board of directors, is the inventor of MC-C225.  He pioneered the research with IMC-225 in the early 1980s and has nurtured its development for study in clinical research.

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