The Phase III study sponsored by Takeda evaluating the PAN + mFOLFOX6 versus BEV + mFOLFOX6 in mCRC patients as first-line treatment in patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC) (Abstract # LBA1)
Panitumumab is a fully human monoclonal antibody targeting the epidermal growth factor receptor (EGFR). In 2019, Panitumumab was approved by the US FDA and EMA for the treatment of RAS wild-type mCRC in combination with FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) in the first-line setting; in combination with FOLFIRI in the second-line setting; and as monotherapy following disease progression after prior chemotherapy treatment.
In the PARADIGM trial, at a median follow-up of 61 months, OS was significantly better with panitumumab in both the population with left-sided tumors and in the overall study population. The median PFS for the overall population was 12.9 months with panitumumab vs. 12 months with bevacizumab. The stratified hazard ratio (HR) for death with panitumumab, compared with bevacizumab, in the left-sided tumor population, was 0.82 (P =.031) and was 0.84 (P =.030) in the full analysis population. The median OS durations for the population with left-sided tumors were 37.9 months in the arm receiving panitumumab and 34.3 months for the arm receiving bevacizumab; however, mPFS duration was not significantly different (13.7 vs. 13.2). However, the Response Rate was also in favor of panitumumab (80.2% vs. 68.6%) in the left-sided tumor population.
“These results support panitumumab plus modified FOLFOX6 in the first-line setting for patients with RAS wild-type and left-sided metastatic colorectal cancer,”- Expert Opinion.
Patients with wild-type RAS metastatic colorectal cancer (mCRC) who had left-sided tumors had a significant overall survival (OS) improvement with the use of modified FOLFOX6 (mFOLFOX6) plus panitumumab compared with mFOLFOX6 plus bevacizumab. The study investigators reported that there were no new safety signals observed. They also concluded that the study demonstrated superiority with panitumumab versus bevacizumab in combination with mFOLFOX6 for left-sided tumors and overall mCRC populations.
Companies- Mirati Therapeutics, Merck Sharp & Dohme, Pfizer, Ono Pharmaceutical, G1 Therapeutics, Daiichi Sankyo, AstraZeneca, and others