Phase III study (20050181) of panitumumab (pmab) with FOLFIRI versus FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC): Pooled safety results

Abstract

4064 Background: Pmab is a fully human anti-EGFr monoclonal antibody (MAb) with activity as a single agent in refractory mCRC. Study 20050181 is the first global, phase III trial investigating an anti-EGFr MAb combined with FOLFIRI as 2nd-line tx for pts with mCRC. Methods: This is a randomized, multicenter, phase III study with pt eligibility criteria that include: histologically/cytologically- confirmed adenocarcinoma of the colon or rectum with metastatic disease; only 1 prior fluoropyrimidine-based chemotherapy regimen for mCRC; ECOG performance status (PS) 0 to 2. No prior EGFr staining is required for inclusion. Pts are randomized 1:1 to receive Pmab 6.0 mg/kg Q2W + FOLFIRI Q2W (Pmab+FOLFIRI) or FOLFIRI Q2W alone (FOLFIRI). Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include overall objective response rate, time to progression, duration of response, and safety. Study endpoints will be investigated by pts’ KRAS mutational status in both arms as a poten...