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Two Pivotal Vectibix® Phase 3 Studies in First and Second-Line Treatment of Metastatic Colorectal Cancer Published in the Journal of Clinical Oncology
Date:10/4/2010

an EGFR inhibitor based on KRAS status in patients with previously treated mCRC.

Results from both trials were previously presented at Europe's largest cancer conference, ECCO 15 – ESMO 34, in September 2009, at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in January, and at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in June.

About the PRIME '203' TrialPatients enrolled in the '203' or PRIME trial (Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy) were randomized to receive either 6.0 mg/kg of Vectibix and FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint of the study was progression-free survival by KRAS status and secondary endpoints included overall survival, objective response rate, time to progression, duration of response and safety. Long-term follow up for overall survival is ongoing.

About the '181' Trial The '181' trial is a global, multicenter, randomized Phase 3 study. Patients enrolled in the study were randomized to receive either 6.0 mg/kg of Vectibix and FOLFIRI Q2W or FOLFIRI alone Q2W. The co-primary endpoints were progression-free survival (which was independently tested) and overall survival. Secondary endpoints included objective response rate, time to progression, duration of response and safety by KRAS status.

About KRASResults from studies performed over the last 25 years indicate that KRAS plays an important role in cell growth regulation. In mCRC, EGFR transmits signals through a set of intracellular proteins. Upon reaching the nucleus, these signals instruct the cancer cell to reproduce and metastasize, leading to cancer progression. Anti-EGFR antibody therapies work by inhibiting the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, in patien
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SOURCE Amgen
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