Usually when a clinical study is stopped it spells disaster for the company performing the study, but in this case Bristol-Myers Squibb Co. (NYSE: BMY) is bucking that trend and investors are thrilled. Not to mention the reason for stopping this study is not often seen.
The company announced that it has stopped its CheckMate-214 study evaluating Opdivo in combination with Yervoy, considering the study has already hit its primary and secondary endpoints. Based on this interim analysis, an independent Data Monitoring Committee recommended that the trial be stopped early.
The study treating patients with previously untreated advanced or metastatic renal cell carcinoma met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS versus sunitinib in all randomized patients.
It’s safe to say that this stoppage was a home run, and it will allow for Bristol-Myers to quickly progress with its study.
Vicki Goodman, M.D., head of new asset development, Bristol-Myers Squibb, commented:
This overall survival result from CheckMate -214 highlights the potential of the combination of Opdivo and Yervoy to provide a new treatment option for first-line advanced renal cell carcinoma patients for whom there is a considerable unmet need. The company looks forward to sharing the full results with regulatory authorities and will incorporate these data into the planned European Society for Medical Oncology (ESMO) Congress presentation later this week.
Shares of Bristol-Myers were last seen up about 4% at $62.16, with a consensus analyst price target of $57.86 and a 52-week trading range of $46.01 to $62.42.