: BMS’ Opdivo plus Yervoy snags FDA nod as first-line treatment for certain colorectal cancer patients

Title

"FDA Grants First-Line Approval to BMS’ Opdivo-Yervoy Combo for MSI-H/dMMR Metastatic Colorectal Cancer"

Keywords

Opdivo-Yervoy approval
FDA first-line treatment
MSI-H/dMMR colorectal cancer
Bristol Myers Squibb
CheckMate-8HW trial
Dual immunotherapy
Progression-free survival

Key Facts

- Approval Details:
The U.S. FDA approved Bristol Myers Squibb's combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adults and children aged 12 and older with unresectable or metastatic colorectal cancer characterized by microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) biomarkers1 4.

- Clinical Trial Support:
The approval was based on the Phase III CheckMate-8HW trial. The combination demonstrated a 79% reduction in the risk of disease progression or death compared to investigator’s choice of chemotherapy, with median progression-free survival (PFS) not reached in the Opdivo-Yervoy arm versus 5.8 months with chemotherapy1 4 9.

- Trial Outcomes:

Progression-free survival at 24 months was significantly higher (72%) for the combo compared to 14% for chemotherapy3.
In comparison with Opdivo monotherapy, the combination reduced the risk of progression or death by 38%, with an overall response rate (ORR) of 71% versus 58% for monotherapy9.

- Implications of Approval:
This is the first FDA-approved dual checkpoint inhibitor for first-line metastatic MSI-H/dMMR colorectal cancer, addressing a population with high unmet medical need due to poor response to chemotherapy4 8.

- Safety Profile:
Common adverse events included fatigue, diarrhea, abdominal pain, pruritus, musculoskeletal pain, and nausea, with a higher rate of grade 3 or 4 events (22%) compared to monotherapy (14%)6 9.

- Global Perspective:
This combination has also been approved in the EU and China for similar indications, reflecting its global recognition as a frontline treatment option for MSI-H/dMMR colorectal cancer2 5.