Drbio - For Cetuximab this data seems to contridict what YM is saying. The fact that YM had such good results with H&N would suggest that their drug obviously does not need a rash to be effective. The billion dollar question is will it be as effective erbitux and the other mabs with no skin rash?
Cetuximab Trials in Colon Cancer: Combination Therapy
Cetuximab has been found to be active as a single agent in colon cancer. Like most monoclonal antibodies, however, its application is expected to be in combination with other therapies. The antibody is given intravenously as a 400 mg/m2 initial dose followed by a 250mg/m2 weekly maintenance dose, with no hospitalization required. In a phase II trial involving 120 highly treatment-experienced patients with advanced disease, the partial response rate of the combination of cetuximab and irinotecan (Camptosar) was 22.5% on independent radiological review. Stable disease was achieved in 7.5% of patients and lasted for a minimum of 12 weeks. Response rate was independent of EGFR expression levels. However, there was a correlation between the grade of skin rash — the most common side effect of this therapy — and tumor inhibition. Objective response rates climbed from 3.8% in those with no skin rash to 14.0% with grade 1 skin rash, 23.5% with grade 2, and 70.6% with grade 3. A similar stepwise correlation was seen with skin rash and median duration of survival (124, 193, 320, and 395 days, respectively).
"Skin rash may be a marker of EGFR blockade," reported Michael Needle, MD, vice president of clinical affairs, ImClone Systems, Inc., Somerville, New Jersey. However, this correlation is not perfect. In a second phase II trial in which cetuximab was used alone in patients with colon cancer refractory to irinotecan, the majority of patients developed a skin rash, "but one patient who responded to treatment did not have a skin rash."
Randy
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