BMS presents new data for Opdivo at ASCO

6 June 2016  •  Author: Victoria White, Digital Content Producer

New data for Bristol-Myers Squibb’s Opdivo has been presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO).


In the CheckMate -032 trial in patients with metastatic urotherlial cancer, the primary endpoint of investigator-assessed confirmed objective response rate (ORR), was 24.4% in patients treated with the therapy, with a minimum follow-up of nine months. Response rates by tumour PD-L1 expression, evaluated as an exploratory endpoint, were similar regardless of PD-L1 expression levels. In patients with PD-L1 <1%, the ORR was 26.8%, and in patients with PD-L1 ≥1%, the ORR was 24%. At one year, patients treated with Opdivo had an overall survival (OS, a secondary endpoint) rate of 45.6%, with a median OS of 9.72 months. 

Padmanee Sharma, M.D., Ph.D., study investigator and professor at The University of Texas MD Anderson Cancer Centre, commented, “We are pleased with the findings from the Phase I/II study, CheckMate -032, which provide support for further study of Opdivo in patients with this cancer to assess outcomes and survival.”

Opdivo in RCC

New long-term OS results from two dose-ranging studies, the Phase I CA209-003 study and the Phase II CA209-010 study, evaluating Opdivo in patients with previously treated advanced renal cell carcinoma (RCC) were also presented. Findings include the first report of four- and five-year survival data from the advanced RCC cohort of study -003, in which OS was an exploratory endpoint. In study -003, 38% of patients were alive at four years, and 34% of patients were alive at five years. In study -010, in which OS was a secondary endpoint, 29% of patients were alive at four years. 

Bristol-Myers Squibb also presenting additional analyses of health-related quality of life data, a secondary endpoint, from the Phase III study, CheckMate -025, which evaluated the therapy versus everolimus in patients with advanced RCC who received prior anti-angiogenic therapy. In this study, 55.4% of patients treated with Opdivo experienced a clinically meaningful improvement in disease-related symptoms, as defined in the study, versus 36.7% of patients treated with everolimus.

Opdivo +Yervoy in colorectal cancer

Interim data was also presented from the Phase II CheckMate -142 trial evaluating Opdivo alone or in combination with Yervoy in patients with previously treated metastatic colorectal cancer, including those with high microsatellite instability (MSI-H). In these first-time clinical results, the primary endpoint of investigator-assessed ORR was 25.5% for Opdivo monotherapy and 33.3% for the combination regimen. The six-month progression-free survival (PFS) rates were 45.9% for Opdivo monotherapy and 66.6% for the Opdivo and Yervoy combination.

Michael J. Overman, M.D., Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, commented, “The response and survival data reported today suggest that this subset of colorectal cancer is responsive to immune therapy and support further investigation into the potential of immune checkpoint inhibition to provide benefits to patients with this type of metastatic colorectal cancer.”

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