O-0012UPDATED RESULTS OF THE RANDOMIZED PHASE 2 IMPACT TRIAL: MAINTENANCE WITH TLR-9 AGONIST MGN1703 VS PLACEBO IN PATIENTS WITH METASTATIC COLORECTAL CARCINOMA (MCRC)

摘要: Background: The PRIME study reported significantly improved progression-free survival (PFS) and overall (OS) with panitumumab + FOLFOX vs in patients WT RAS (exons 2, 3 4 of KRAS NRAS) mCRC a prospective-retrospective analysis (unpublished data). PEAK study, presented here, was an estimation the treatment effect FOLFOX6 or bevacizumab 1st-line wild-type (WT) mCRC. Methods: This designed to assess on PFS (primary endpoint) OS study. exon 2 tumors were required for entry. Transgenomic SURVEYOR/WAVE™ bidirectional Sanger sequencing conducted independently banked specimens detect mutations (codons 59/61), 117/ 146); NRAS 12/13), 117/146); BRAF 15 (codon 600). Results: Of 285 (exon 2) randomized, 278 received treatment. ascertainment rate is currently 75%. For RAS, HRs (pmab:bev) 0.63 (95% CI, 0.43-0.94; p = 0.02) 0.55 0.30-1.01; 0.06) (Table). Worst grade 3-5 adverse event rates consistent primary analysis. Conclusion: favored relative this mCRC, suggesting that activating appear be predictive effect. Safety profiles both arms previously studies.