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IMC-C225 Combined with Chemotherapy Shows Encouraging Response in Patients with Advanced Head and Neck Cancer

IMC-C225 Combined with Chemotherapy Shows Encouraging Response in Patients with Advanced Head and Neck Cancer
M. D. Anderson News Release 05/13/01

In a preliminary report of a national Phase II trial led by The University of Texas M. D. Anderson Cancer Center, patients with progressive head and neck cancer have responded favorably to the new biological treatment IMC-C225 combined with a standard chemotherapy.


Dr. Roy S. Herbst, principal investigator for the study and assistant professor of thoracic/head and neck medical oncology at M. D. Anderson, presented the data in San Francisco at the 37th annual meeting of the American Society for Clinical Oncology. The trial included 53 sites around the United States.

"Interim Phase II trial results suggested that IMC-C225 appear have an effect in patients who have previously failed chemotherapy. This is a group of patients who has very few options," said Dr. Herbst. "While it will ultimately require a Phase III trial to give us data on what the combination can mean for a patient's survival, this study shows encouraging potential for this drug combination. This study demonstrates benefit for the patient and proof of concept for this drug."

There were two tracks for the Phase II trial that so far has 96 patients with squamous cell carcinoma of the head and neck. All the patients initially received a combination chemotherapy that included cisplatin. Of those, 22 patients responded to the initial therapy and since they were doing well, did not receive IMC-C225. Eleven other patients dropped out of the study before they could get IMC-C225.

The remaining 63 patients whose disease had either stabilized or progressed on the first combination of chemotherapy with cisplatin went on to receive IMC-C225 plus additional chemotherapy with cisplatin.

Of those 63 patients who received both IMC-C225 and chemotherapy, 20 percent responded to the treatment in each of the two groups.

According to Dr. Herbst, combining the chemotherapy with the anti-epidermal growth factor antibody IMC-C225 was the key to the study's promising outcome.

"Patients with recurrent squamous cell carcinoma of the head and neck who receive cisplatin early in their diagnosis and whose tumors do not respond, rarely do well with a second round of similar treatment. The rate of tumor shrinkage is less than five percent," said Dr. Herbst.  "This study shows that a patient with this type of head and neck cancer is better off getting IMC-C225 with their chemotherapy."

According to Dr. Herbst, IMC-C225 appears to work especially well in head and neck cancers because approximately 90 percent of head and neck cancers are highly dependent on molecules known as Epidermal Growth Factors (EGF) receptors, the target for IMC-C225. 

"Squamous cell carcinoma, which is the most common form of head and neck cancer, has a large number of EGF receptors on the surface of their cells," said Dr. Herbst."That is why we believe this compound may be effective on this type of tumor. It binds to the surface of the cell, interferes with its ability to grow and then delivers a knockout punch with the enhanced chemotherapy."

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

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 IMC-C225. He pioneered the research with IMC-C225 in the early 1980s and has nurtured its development for study in clinical research.

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© 2015 The University of Texas MD Anderson Cancer Center