H&NC wasn't first priority for nati-EGF type cancer drugs, but IMCL investors may not be happy with outcome. Remain to be seen what PIII will bring?
However, based on IMCL-BMY effort to influence size of the Merck refractory CC in EU I am not expecting miracle.
Miljenko
Saturday May 18, 5:45 pm Eastern Time Press Release SOURCE: Bristol-Myers Squibb; ImClone Systems Incorporated Study Demonstrates Utility of ERBITUX (TM) (Cetuximab) Combined With Cisplatin for Treatment of Refractory Head and Neck Cancer ORLANDO, Fla., May 18 /PRNewswire-FirstCall/ -- ImClone Systems Incorporated (Nasdaq: IMCL - News) and Bristol-Myers Squibb (NYSE: BMY - News) announced data today on the use of the investigational monoclonal antibody, ERBITUX(TM) (cetuximab) in combination with cisplatin in treating refractory squamous cell head and neck cancer (SCCHN).
Data were presented by Merrill S. Kies, M.D. (MD Anderson Cancer Center, Houston, TX) during a poster session (#925) at the American Society of Clinical Oncology (ASCO) annual meeting.
The Phase II study involved patients with SCCHN who failed to respond to platinum-based chemotherapy (cisplatin). Of the 78 evaluable patients in the study who had progressive disease while receiving cisplatin, 9 patients (11.5 percent) achieved a partial response (characterized as greater than 50 percent tumor regression) and 13 patients (16.7 percent) achieved stable disease when treated with the combination of cisplatin plus cetuximab. The overall rate of disease control (partial response plus stable disease) is 28.2 percent.
The most common adverse events reported during the study using the combination of cetuximab and cisplatin were nausea (occurring in 51 percent of patients) and asthenia (occurring in 49 percent of patients).
"The data seen in this study is encouraging as it suggests that the combination of cetuximab and cisplatin will be an active regimen in patients with recurrent head and neck cancer," said Dr. Kies, professor of medicine, department of thoracic/head and neck medical oncology, MD Anderson Cancer Center.
Cetuximab, also known as C225, is an investigational drug designed to target and block the Epidermal Growth Factor Receptor (EGFR), which, according to research, is expressed in many solid tumor types. Cetuximab is being co-developed by ImClone Systems Incorporated and Bristol-Myers Squibb in the United States and Canada. The companies also maintain co-development rights in Japan.
According to the American Cancer Society, more than 40,000 Americans are diagnosed with head and neck cancer each year. Nearly 12,000 Americans die from head and neck cancer annually. |