BMS Launches Phase IIIb Trial of Opdivo ± Yervoy vs Chemotherapy in MSI-H/dMMR Metastatic Colorectal Cancer in China

Text | Baihuawen

On June 23, BMS initiated the registration of a Phase IIIb study in China evaluating Opdivo monotherapy, Opdivo plus Yervoy, or investigator’s choice of chemotherapy for the treatment of metastatic colorectal cancer with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

Source: Drug Clinical Trial Registration and Information Publicity Platform

This study is planned to be conducted across 147 centers globally, with a target enrollment of 494 patients, including 20 patients from China. The study aims to directly compare the clinical benefits of Opdivo plus Yervoy versus Opdivo monotherapy in patients with dMMR/MSI-H mCRC, as assessed by PFS, ORR, and OS. Additionally, it seeks to fill the data gap regarding the comparative efficacy of immunotherapy versus chemotherapy in patients with dMMR/MSI-H mCRC who have either not previously received systemic therapy or have received only one prior line of systemic therapy.

The indication for Opdivo monotherapy in previously treated metastatic colorectal cancer with microsatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR) received accelerated approval from the FDA in August 2017, and the indication for the Opdivo plus Yervoy combination therapy in MSI-H or dMMR metastatic colorectal cancer was approved by the FDA in July 2018.