NEW YORK, Nov. 14 ImClone Systems Incorporated(Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) announced todayresults from a multicenter, open-label, randomized Phase III trial, publishedin the New England Journal of Medicine, in which ERBITUX(R) (cetuximab) as asingle agent demonstrated a significant improvement in overall survival inpatients with metastatic colorectal cancer (mCRC) refractory to approvedchemotherapy agents. The study compared ERBITUX plus best supportive care(BSC) to BSC alone in patients with mCRC whose disease had progressed throughtreatment with all approved chemotherapy, including irinotecan, oxaliplatin,and fluoropyrimidines.
The independent study (NCIC CTG CO.17), conducted by the National CancerInstitute of Canada Clinical Trials Group (NCIC CTG) in collaboration with theAustralasian Gastro-Intestinal Trials Group (AGITG), involved 572 patients anddemonstrated that treating patients with ERBITUX as a monotherapy plus BSCsignificantly increased overall survival compared to BSC alone. BSC includedpalliative therapies designed to alleviate pain and treat other effects causedby mCRC.
"This is the first time an antibody used as a single agent in colorectalcancer has demonstrated an overall survival benefit. These outcomes add tothe growing body of evidence supporting the significant clinical benefits ofERBITUX," said Eric K. Rowinsky, M.D., Chief Medical Officer and Senior VicePresident of ImClone Systems.
"These data demonstrate that ERBITUX may provide certain colorectal cancerpatients with additional time -- even when other available treatment optionshave failed," said Maurizio Voi, M.D., Executive Director, Oncology GlobalMedical Affairs, Bristol-Myers Squibb. "The results are part of ourcomprehensive clinical development program designed to fully understand thepotential uses of ERBITUX."
The study enrolled patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer who had been previously treated.ERBITUX was administered at the recommended dose and schedule: 400 mg/m2initial dose, followed by 250 mg/m2 weekly until disease progression orunacceptable toxicity.
In this study, the median survival was 6.1 months for patients treatedwith ERBITUX plus BSC versus 4.6 months for patients on BSC alone (HazardRatio: 0.77, P=0.005). Treatment with ERBITUX monotherapy resulted in asignificant improvement in progression-free survival versus BSC alone (HazardRatio: 0.68, P<0.001). Twenty-three patients (8.0%) treated with ERBITUX andno patients on BSC alone had partial responses (P<0.001).
Grade 3/4 adverse events (occurring in greater than or equal to 10% ofpatients in either group) reported more frequently in the ERBITUX plus BSCtreatment arm compared with the BSC only arm included fatigue (33% vs 26%),other pain (16% vs 7%), dyspnea (16% vs 12%), infection without neutropenia(13% vs 6%) rash/desquamantion (12% vs <1%), and other gastrointestinal (10%vs 8%). Grade 3/4 infusion reactions (hypersensitivity) occurred in 5% ofpatients in the ERBITUX plus BSC arm. The most common (occurring in greaterthan or equal to 25% of patients in either group) adverse events of any gradewere rash/desquamation, fatigue, abdominal pain, other pain, dry skin,dyspnea, constipation, pruritus, diarrhea, vomiting, infection withoutneutropenia, headache, fever, insomnia, cough, other dermatology, andstomatitis.
This study supported the recent label change for ERBITUX -- approved bythe U.S. Food and Drug Administration on October 2, 2007 -- to include overallsurvival data as a monotherapy agent in patients with EGFR-expressing mCRCafter failure of irinotecan- and oxaliplatin-based chemotherapy regimens.
About Colorectal Cancer
In the U.S., approximately 154,000 people will be diagnosed with cancer ofthe colon or rectum this year. More than half of