Opdivo Combination Missed Goal in Phase III Kidney Cancer Study

Bristol-Myers Squibb (BMS) reported mixed results for its promising immunotherapy combination in a late-stage study labeled Checkmate -214.

Investigators were comparing nivolumab (Opdivo) in combination with ipilimumab (Yervoy) on intermediate and poor-risk patients with previously untreated advanced or metastatic renal cell carcinoma against sunitinib (Sutent), the traditional standard of care for this form of cancer.

BMS announced the Opdivo and Yervoy combination achieved the co-primary endpoint of objective response rate (ORR) where patients experienced a 41.6 percent ORR compared to 26.5 percent for the Sutent group. Progression-free survival (PFS) improved slightly where the median rate was 11.56 months for the Opdivo combination while it reached 8.38 months for Sutent. However, the PFS results were not considered to be statistically significant.

Median duration of response was 18.17 months for Sutent, while the treatment combination has not reached the response measure.

Compared to Sutent, this lack of data for median duration of response indicates Opdivo and Yervoy failed to produce enough of a difference to keep the cancer from spreading.

“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. This is an important study in first-line renal cancer as these patients need new options,” said Vicki Goodman, M.D., the development lead for Melanoma and Genitourinary Cancers at BMS.

The company will continue the study as planned in order to allow the third co-primary endpoint of overall survival to mature.

Still, this news is emblematic of how the development process can be a struggle for these next-gen cancer therapies.

Merck’s Keytruda, the closest competitor to BMS’s offerings, missed a primary endpoint of overall survival in a Phase III study focusing on previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma.