Bristol-Myers releases interim data on Opdivo plus Yervoy

Bristol-Myers Squibb (NYSE: BMY) has announced data from a Phase II trial evaluating Opdivo (nivolumab) as a monotherapy and in combination with Yervoy (ipilimumab), in colorectal cancer (CRC).

The study, dubbed CheckMate-142, shows an objective response rate of 54.8%. Median overall survival was not reached and the overall survival rate at 9-months was 87.6% for patients receiving Opdivo plus Yervoy. The data were presented at the American society of Clinical Oncology (ASCO) meeting taking place in Chicago.

“The clinically meaningful survival and response data for patients with dMMR or MSI-H colorectal cancer treated with Opdivo in combination with Yervoy are very promising,” said Thierry Andre of St. Antoine Hospital in Paris.

“These interim data are important as they build on the study results observed with Opdivo monotherapy in these patients and show the potential of an Immuno-Oncology combination in this advanced type of colorectal cancer for which there is a significant unmet need.”

Approximately 5% of metastatic CRC patients have dMMR or MSI-H biomarkers, and these patients are less likely to benefit from conventional chemotherapy than patients whose tumors are mismatch repair proficient.

Ian Waxman, development lead in gastrointestinal cancers at Bristol-Myers, said: “We are encouraged by these interim results for Opdivo plus Yervoy, and we look forward to further evaluating the efficacy and safety of our immuno-oncology combination therapies in metastatic colorectal cancer, as well as across a broad range of other tumor types.”

Treatment-related adverse events occurred in 67.9% of patients, with 13.1% of patients discontinuing treatment. No treatment-related deaths were reported.

Colorectal cancer is the third most common form of cancer, with a worldwide incidence of 1.4 million cases, and is the fourth most common cause of cancer deaths.

In the USA, CRC is the second leading cause of cancer-related deaths among men and women combined, with more than 135,000 new cases expected to be diagnosed annually.