On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) colorectal cancer (CRC). This approval marks the first globally for this indication and signifies Bristol-Myers Squibb’s achievement of a “global first launch” for a new drug indication in China.
The approval was based on the CheckMate-8HW study, the first phase III trial to demonstrate that the dual immune combination therapy of Opdivo and Yervoy, compared to standard chemotherapy, brings significant clinical benefits to patients with MSI-H/dMMR metastatic CRC in the first-line setting. According to a blinded independent central review assessment, the primary endpoint of progression-free survival (PFS) showed a statistically significant and clinically meaningful improvement with the Opdivo plus Yervoy combination over the chemotherapy control, reducing the risk of disease progression or death by 79% (P<0.0001). At 24 months, the PFS rate for the Opdivo plus Yervoy group was 72%, compared to 14% for the chemotherapy group. Consistent benefits were observed across all prespecified subgroups, including patients with RAS and BRAF mutations and those with liver, lung, and peritoneal metastases at baseline. The safety profile of Opdivo plus Yervoy was favorable, with no new safety signals detected, and the rate of grade 3/4 treatment-related adverse events was 23%, compared to 48% for the chemotherapy group.
Opdivo and Yervoy are two distinct immunotherapies targeting different immune checkpoints (PD-1 and CTLA-4), activating the body’s immune system to fight cancer. Their combination therapy is the first dual immune combination therapy approved globally and in China, with a clear synergistic effect: the CTLA-4 inhibitor Yervoy promotes the activation and proliferation of T cells, while the PD-1 inhibitor Opdivo helps the activated T cells recognize and kill cancer cells. Some of the T cells activated by Yervoy can also differentiate into memory T cells, improving long-term immune surveillance and achieving effective, durable anti-tumor effects. Opdivo and Yervoy are the only immune checkpoint inhibitors globally developed with direct involvement from a Nobel laureate in Physiology or Medicine.- Flcube.com
