Colorectal Cancer Breakthrough: Bristol Myers Squibb Secures EC Approval for Opdivo + Yervoy in MSI-High mCRC
Bristol Myers Squibb has announced that the Colorectal Cancer European Commission (EC) has approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as the first-line treatment for adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). This approval represents a significant milestone for patients in the European Union (EU) suffering from this aggressive form of cancer, which has historically had limited treatment options and poor prognosis.
MSI-H or dMMR mCRC occurs in a small subset of patients (approximately 5-7%) who do not respond well to conventional chemotherapy. The approval of Opdivo and Yervoy offers these patients a promising new option that targets the immune system to fight cancer. The combination has been shown to provide clinically meaningful improvements in progression-free survival, significantly reducing the risk of disease progression or death compared to standard chemotherapy.
This approval is valid across all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway. It further expands the range of indications for Opdivo-based therapies in the EU, which already includes treatments for various cancer types, such as melanoma, non-small cell lung cancer, and renal cell carcinoma.
A Significant Step in Colorectal Cancer Treatment
Is the second leading cause of cancer death in Europe, and patients diagnosed with metastatic colorectal cancer (mCRC) often face challenges with disease progression and poor survival outcomes. Among these patients, approximately 5-7% present with MSI-H or dMMR tumors, which are less likely to respond to conventional chemotherapy. These Colorectal Cancer patients often experience limited benefits from standard treatments and typically have a more unfavorable prognosis. The EC’s approval of Opdivo plus Yervoy provides a promising new treatment avenue for this difficult-to-treat group, aiming to delay disease progression and improve overall survival outcomes.
Colorectal Cancer Dana Walker, M.D., M.S.C.E., vice president and global program lead for Opdivo at Bristol Myers Squibb, emphasized the importance of this approval, stating, “Colorectal cancer is a leading cause of Colorectal Cancer mortality, and patients with MSI-H/dMMR tumors face particularly poor prognoses. The EC’s decision to approve Opdivo plus Yervoy offers a much-needed treatment option for these patients, and underscores our commitment to advancing treatment options for this underserved population.”
Key Results from the CheckMate -8HW Trial
The approval Colorectal Cancer of Opdivo plus Yervoy in the treatment of MSI-H or dMMR mCRC is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier in the year. The data demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), which was one of the dual primary endpoints of the trial. Patients receiving the combination therapy showed a remarkable 79% reduction in the risk of Colorectal Cancer disease progression or death compared to those receiving the investigator’s choice of chemotherapy. This improvement in PFS was confirmed by Blinded Independent Central Review (BICR).
The Colorectal Cancer CheckMate -8HW trial also provided valuable safety data for the Opdivo plus Yervoy combination therapy. The safety profile was consistent with prior studies, with no new safety concerns identified. The combination therapy for metastatic colorectal cancer was manageable using established protocols. Notably, grade 3/4 treatment-related adverse events (TRAEs) were less common in the Opdivo plus Yervoy group (23%) compared to the chemotherapy group (48%). Furthermore, 17% of patients in the Opdivo plus Yervoy group had to discontinue treatment due to TRAEs, significantly lower than the 32% discontinuation rate in the chemotherapy group. These findings highlight the tolerability of Opdivo plus Yervoy, making it a promising option for patients with MSI-high metastatic colorectal cancer.
Pivotal Efficacy and Safety Data
The CheckMate -8HW trial followed Colorectal Cancer patients for a median duration of approximately 31.5 months, with the following key efficacy findings:
- Progression-Free Survival (PFS): The combination of Opdivo plus Yervoy reduced the risk of Colorectal Cancer disease progression or death by 79%. The median PFS in the Opdivo plus Yervoy arm was not reached (95% CI: 38.4-NE), compared to 5.9 months in the chemotherapy arm (95% CI: 4.4-7.8). The PFS benefit was consistent across all pre-specified subgroups, including those with KRAS or NRAS mutations and colorectal Cancer patients with baseline liver, lung, or peritoneal metastases.
- Safety: The safety profile for Opdivo plus Yervoy remained consistent with previous reports. The occurrence of severe treatment-related adverse events (grade 3/4) was lower in the Opdivo plus Yervoy arm (23%) compared to the chemotherapy arm (48%). Additionally, the rate of any-grade treatment-related discontinuations was 17% for the Opdivo plus Yervoy group, compared to 32% for the chemotherapy group.
Implications for Treatment in the European Union
The European Commission’s approval of Colorectal Cancer Opdivo plus Yervoy for MSI-H or dMMR metastatic colorectal cancer (mCRC) extends across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. This approval further expands the range of indications for Opdivo-based therapies in the EU, which already includes treatments for colorectal cancers, melanoma, non-small cell lung cancer, and renal cell carcinoma.
Bristol Myers Squibb Colorectal Cancer expressed its gratitude to the patients and investigators involved in the CheckMate -8HW trial, recognizing their vital role in advancing treatment options for patients with MSI-H/dMMR mCRC. This approval represents a significant milestone for the company and underscores its commitment to improving outcomes for colorectal cancer patients across Europe.
