Bristol Myers Squibb (BMS) has unveiled groundbreaking results from the Phase 3 CheckMate -8HW trial, marking a significant advancement in the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). The trial evaluated Opdivo (nivolumab) in combination with Yervoy (ipilimumab) as a first-line treatment, compared to conventional chemotherapy.
The Opdivo and Yervoy dual immunotherapy combination demonstrated a remarkable 79% reduction in the risk of disease progression or death when assessed by Blinded Independent Central Review (BICR). This substantial improvement in progression-free survival (PFS) is statistically significant and clinically meaningful. It represents a significant step forward in the treatment of MSI-H/dMMR mCRC, a patient population that typically does not benefit as much from chemotherapy.
Opdivo and Yervoy Combo Breaks Ground in Colorectal Cancer Treatment
The findings from this Phase 3 trial (Abstract #LBA768) will be presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, emphasizing the importance of this breakthrough. The data showed that PFS improvement with Opdivo plus Yervoy became apparent at approximately three months and was sustained throughout the trial. Notably, the median PFS for the Opdivo plus Yervoy group was not yet reached, indicating a substantial and enduring benefit, whereas the chemotherapy arm had a median PFS of 5.9 months.
These positive results were consistent across various patient subgroups, including those with KRAS or NRAS mutations and those with baseline liver, lung, or peritoneal metastases. Importantly, the safety profile of the Opdivo and Yervoy combination was manageable and consistent with prior data, with no new safety concerns identified. Grade 3/4 treatment-related adverse events occurred less frequently in the Opdivo plus Yervoy arm compared to the chemotherapy arm.
Dr. Thierry Andre, Head of the Medical Oncology Department at Sorbonne University and Hospital Saint-Antoine in Paris, France, emphasized the significance of these findings. He noted that patients with MSI-H/dMMR metastatic colorectal cancer typically derive less benefit from chemotherapy. However, the Opdivo and Yervoy combination demonstrated impressive improvements in PFS, providing meaningful efficacy and potentially changing the treatment landscape for this patient population.
This study marks a groundbreaking development in the field of oncology, as Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as a first-line treatment in MSI-H/dMMR metastatic colorectal cancer. These findings underscore the potential of immunotherapy in revolutionizing the treatment of this challenging cancer type.
Transformative Impact in MSI-H/dMMR Colorectal Cancer Treatment
Dr. Dana Walker, Vice President and Global Program Lead for Gastrointestinal and Genitourinary Cancers at Bristol Myers Squibb highlighted the transformative impact of Opdivo plus Yervoy in this trial. She noted that these results build upon the previously demonstrated benefit of Opdivo and Yervoy in MSI-H/dMMR metastatic colorectal cancer, as seen in the CheckMate -142 trial. BMS remains committed to exploring the potential of these therapies to benefit more patients in need.
The CheckMate -8HW trial is ongoing, with additional endpoints yet to be assessed. These include the second dual primary endpoint of PFS in patients receiving Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy, as well as overall survival (OS). The trial has the potential to further solidify the role of Opdivo and Yervoy in MSI-H/dMMR mCRC treatment.
Resource: Bristol Myers Squibb, January 20, 2024
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