| BSNS WIRE) Amgen Discontinues Vectibix(TM) Treatment in PACCE Trial Evaluatig Vectibix(TM) as Part of Triple Combination RegimenAmgen Discontinues Vectibix(TM) Treatment in PACCE Trial Evaluating Vectibix(TM)as Part of Triple Combination Regimen Business Editors / Health/Medical Writers THOUSAND OAKS, Calif.--(BUSINESS WIRE)----Amgen (NASDAQ:AMGN) today announced that it has discontinuedVectibix(TM) (panitumumab) treatment in the PACCE trial evaluating theaddition of Vectibix to standard chemotherapy and Avastin(R)(bevacizumab) for the treatment of first-line metastatic colorectalcancer (mCRC). The PACCE trial investigated a treatment regimen thatused dual biologics combined with oxaliplatin- or irinotecan-basedchemotherapy. This regimen is not currently used in clinical practice. The decision to discontinue Vectibix treatment in the trial wasbased on a preliminary review of data from a pre-planned interimefficacy analysis scheduled after the first 231 events (death ordisease progression). This analysis revealed a statisticallysignificant difference in progression-free survival in favor of thecontrol arm. An unplanned analysis of overall survival alsodemonstrated a statistically significant difference favoring thecontrol arm. Additional analyses are ongoing, and Amgen plans topresent the results at an upcoming scientific forum. "Patient safety is Amgen's top priority. For this reason, we havedecided to discontinue Vectibix treatment in the PACCE trial while wecomplete additional analyses of these preliminary results. We hadhoped that adding Vectibix to the current U.S. standard-of-care forpatients newly-diagnosed with mCRC would improve outcomes withoutexcessive added toxicity. Unfortunately, it appears that addingVectibix to Avastin, when used in combination with oxaliplatin- oririnotecan-based chemotherapy, increased toxicity, without improvingefficacy," said Roger M. Perlmutter, M.D., Ph.D., executive vicepresident of Research and Development at Amgen. Amgen has notified the FDA and study investigators that patientswho are still receiving treatment in the PACCE study shoulddiscontinue Vectibix treatment. Patients will have the option ofcontinuing per protocol treatment without Vectibix. In January 2007, Amgen informed all investigators and regulatoryauthorities about safety information arising from a planned interimsafety analysis of the PACCE trial. A review of the interim analysisshowed an increased incidence of grade 3 severe events of diarrhea,dehydration and infections in the Vectibix-treated patients. Inaddition, an increased incidence of pulmonary embolism was observed inpatients who received Vectibix compared with those who did not (4percent and 2 percent, respectively). One (less than 1 percent) fatalevent of pulmonary embolism occurred in a patient receiving Vectibix. Amgen is continuing to explore Vectibix as a single biologiccombined with chemotherapy in Phase 3 first- and second-lineregistrational trials. No other clinical studies are being modified atthis time. However Amgen is evaluating data across all studies. |
