BMS’s Opdivo and Yervoy colorectal cancer trials show promising results

On January 22, BMS announced encouraging findings from the CheckMate -8HW clinical trial, showing that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) was effective in treating patients with microsatellite-high instability (MSI-H) or mismatch repair deficiency (dMMR). It has been shown that it is a first-line treatment option for patients. ) Metastatic colorectal cancer (mCRC). BMS presented this data supporting the use of immune checkpoint inhibitors (ICIs) in combination in patients with newly diagnosed advanced colorectal cancer subtypes at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. Announced. Currently, the standard of care (SOC) for CRC is slowly transitioning from fluorouracil-containing chemotherapy to targeted therapy and immunotherapy. However, addressing mCRC poses significant challenges as there is considerable unmet need for effective treatment.

The frontline cohort of the open-label, randomized, Phase III CheckMate -8HW study enrolled 303 participants and was randomized to one of three groups: nivolumab monotherapy, nivolumab plus ipilimumab combination therapy, or chemotherapy. assigned to. After a median follow-up of 24.3 months, median progression-free survival (PFS) remained unknown for 171 patients who received nivolumab plus ipilimumab, compared with 5.8 for 84 patients who received standard therapy. It was a month. This difference between the two groups corresponds to a remarkable 79% reduction in the risk of disease progression or death (hazard ratio) associated with the utilization of two ICI regimens. [HR] 0.21, 95% confidence interval [CI] [0.14, 0.32]; P < 0.0001). A comprehensive safety analysis also demonstrated preference for ICI combination therapy over chemotherapy, despite a different range of adverse events. Overall, grade 3/4 treatment-related adverse events (TRAEs) occurred in 23% of patients receiving ICI combination therapy with or without targeted therapy, compared with 48% in the chemotherapy arm. In contrast to . The incidence of grade 3/4 serious TRAEs was the same in both treatment arms at 16%. Furthermore, treatment discontinuation due to TRAE was observed in 17% of patients receiving dual ICI therapy compared with 32% of patients receiving standard therapy. Of note, two treatment-related deaths were recorded in the dual ICI group, but none in the chemotherapy group.

Opdivo is expected to compete directly with MSD’s PD-1 inhibitor Keytruda (pembrolizumab), which received approval as a first-line monotherapy for MSI-H/dMMR colorectal cancer in 2020, and global data According to patient-based forecasts, last year’s sales reached $2 billion. . At the same time, Opdivo’s total annual sales are expected to increase slightly from $2.0 billion in 2023 to $2.4 billion in 2031. This slight increase may be due to the impending patent expiration in 2026 in the EU and 2028 in the US. Keytruda’s patent will also expire in 2028, but because it has established itself as the first in the market, it is expected to have higher sales than Opdivo. Nevertheless, in indirect comparisons, Opdivo and Yervoy showed more robust data than Keytruda, and in the KEYNOTE-177 study, Keytruda monotherapy, whether administered alone or in combination with targeted therapy, It reduced the risk of progression or death by 40% compared to chemotherapy. Untreated MSI-H/dMMR colorectal cancer. Nivolumab plus ipilumab showed a substantial 79% risk reduction compared to chemotherapy, a notable improvement.