Opdivo adn Stivarge *nivolumab and regorefanib) for colorectal cancer –
Results of a single-arm phase 2 study of regorafenib (Stivarga) plus nivolumab (Opdivo) in patients with mismatch repairproficient (pMMR)/microsatellite stable (MSS) colorectal cancer (CRC) found a discrepancy in efficacy between the Japanese and North American Population, according to a presentation at the 2021 American Society of Clinical Oncology Annual Meeting.
The benefit and efficacy of immunotherapy for the treatment of pMMR/MSS metastatic CRC has yet to be established. However, a recent Japanese phase 1b trial found that the combination of regorafenib plus nivolumab had encouraging activity and a manageable safety profile,2 putting it at odds with a study of this combination in North America.
The Japanese REGONIVO phase 1b trial showed that the combination of the multi-kinase inhibitor regorafenib plus nivolumab had encouraging activity with an objective responserate of 33% in patients with microsatellite stable metastatic colorectal cancer and had manageable safety. he efficacy of combination treatment with regorafenib plus nivolumab in the North American population was not consistent with the results in the Japanese population,” said Fakih. The objective response rate was 7%. For the subgroup of patients without liver metastases, the overall response rate was 22%.
Wang C, Chevalier D, Saluja J, Sandhu J, Lau C, Fakih M. Regorafenib and Nivolumab or Pembrolizumab Combination and Circulating Tumor DNA Response Assessment in Refractory Microsatellite Stable Colorectal Cancer. Oncologist. 2020 Aug;25(8):e1188-e1194.
Fakih M, Raghav KPS, Chang DZ, et al. Single-arm, phase 2 study of regorafenib plus nivolumab in patients with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) colorectal cancer (CRC). J Clin Oncol. 2021;39(suppl 15):3560. doi:10.1200/JCO.2021.