Phase III PARADIGM trial of Vectibix shows superiority over bevacizumab in colorectal cancer.
Amgen and Takeda announced that new data from the Phase III PARADIGM clinical trial of Vectibix (panitumumab) in Japanese patients with previously untreated unresectable wild-type RAS metastatic colorectal cancer (mCRC) are being featured during the June 5 Plenary Session (Abstract #LBA1) of the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago and online.
PARADIGM is a randomized trial conducted in Japan comparing the efficacy and safety of Vectibix plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 in chemotherapy-naive patients with unresectable advanced mCRC (n=823). This is the first prospective trial to evaluate treatment options for patients with wild-type RAS mCRC and left-side primary tumor (descending colon, sigmoid colon, and rectum). The results of the trial showed that the mFOLFOX6 + Vectibix combination provides a statistically significant improvement in overall survival (OS) over the mFOLFOX6 + bevacizumab combination in patients with a left-sided primary tumor or regardless of tumor locations (median OS for left-sided tumors: 37.9 vs. 34.3 months, HR=0.82 [95.798% CI: 0.68-0.99], p=0.031, overall median OS: 36.2 vs. 31.3 months, HR=0.84 [95% CI: 0.72-0.98], p=0.030). The safety profile of Vectibix in this study was similar to clinical study results previously published.
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