Bristol-Myers Squibb (BMS) announced that its Phase III CheckMate-8HW study of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of metastatic colorectal cancer has received co-leading results in a planned interim analysis. It was announced that one of the evaluation items had been achieved.
The randomized, open-label CheckMate-8HW study (NCT04008030) enrolled 974 subjects and tested Opdivo alone or chemotherapy in patients with microsatellite high instability (MSI-H) or mismatch repair deficiency (dMMR). We evaluated Opdivo and Yervoy compared to therapy. Metastatic colorectal cancer.
The co-primary endpoint of a statistically significant improvement in progression-free survival (PFS) with the combination therapy compared to chemotherapy in the first-line setting was met. The trial will also evaluate his PFS in combination with Opdivo alone across different treatment lines.
Opdivo, a PD-1 inhibitor monoclonal antibody (mAb), was first approved in 2015 for the treatment of metastatic renal cell carcinoma. The drug has since received approval for several indications, including gastric cancer, B-cell Hodgkin lymphoma, and hepatocellular carcinoma.
In a statement accompanying the study results, Dana Walker, vice president and global program leader for gastrointestinal and genitourinary cancers at BMS, said: “These results further support the benefits of dual inhibition of PD-1 and CTLA-4 and demonstrate our continued efforts to pursue combination strategies.” may help improve outcomes. ”
BMS is studying Opdivo in multiple combination clinical trials for various indications. For example, in October, the company reported that its Phase III CheckMate-67T trial of subcutaneous Opdivi in advanced or metastatic clear cell renal cell carcinoma (ccRCC) met its co-primary endpoint.
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MerckMerck & Co.’s (MSD) 2022 financial results show the company’s Keytruda (pembrolizumab) is one of BMS’s major competitors, and the PD-1 inhibitor generated $21 billion in sales last year. . GlobalData’s patient-based forecasts predict that Opdivo’s total annual sales will decline significantly from $8.7 billion in 2028 to $85 million in 2030, with sales expected to decline significantly by 2026 in the EU and 2028 in the US. The patent has expired, threatening the drug’s sales growth. Although Keytruda’s patent expires in 2028, the drug is expected to maintain higher sales due to its first-to-market advantage.
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