BMS left red-faced as Opdivo+Yervoy fails to beat rival Pfizer drug in kidney cancer

pharmafile | August 16, 2017 | News story | Research and Development BMS, Kidney cancer, Yervoy, life sciences, opdivo, pharma, pharmaceutical 

Bristol-Myers Squibb has been left somewhat red-faced after its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) failed to show any statistically significant benefits in progression-free survival (PFS) versus Pfizer’s Sutent (sunitinib) in the treatment of intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma.

While there was an improvement in PFS, it was not sizeable enough for BMS to reveal directly, though median PFS was 11.56 months against Sutent’s 8.38. Median duration of response was also not reached, compared to the 18.7 months recorded by Sutent.

The combination did, however, achieve an objective response rate (ORR) of 41.6% compared to Sutent’s 26.5%, meeting its second co-primary endpoint, as a larger proportion of patients using BMS’ therapy experienced a shrinkage of their tumours.

The trial is ongoing as BMS seeks to evaluate the therapy’s ability to meet its third co-primary endpoint of overall survival, the data for which requires time to develop, according to the company.

“We are encouraged by the totality of the CheckMate-214 data. The overall response rate and durability of response favored the combination of Opdivo and Yervoy, and the trend for PFS supports the potential of the combination in intermediate and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer,” explained Vicki Goodman, Development Lead, Melanoma and Genitourinary Cancers at BMS. “This is an important study in first-line renal cancer as these patients need new options. We look forward to presenting the full results from this study at an upcoming medical meeting.”

“Opdivo is now well established as standard of care in the treatment of second-line renal cell carcinoma,” she continued. “The company plans to share these important first-line data with regulatory authorities and we look forward to reporting overall survival when these data mature.”

Matt Fellows

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