Therefore, there are multiple ongoing phase III combination trials with VEGF and immunotherapy. Some have completely enrolled, and we are awaiting the final results and follow-up for these patients while others are still ongoing. In the setting of the ipilimumab (Yervoy)/nivolumab (Opdivo) data coming out from CheckMate-214 earlier this year at the 2017 ESMO Congress, the ongoing studies may have trouble enrolling patients and randomizing them to sunitinib as the standard-of-care treatment arm.
What do you believe to be the biggest advancement in kidney cancer this year?
In 2017 in RCC, the major breakthrough was the report of the CheckMate-214 study. The study randomized patients to the combination of nivolumab and ipilimumab for 4 doses, followed by nivolumab maintenance versus standard-of-care sunitinib. It showed that, in metastatic patients with intermediate- and poor-risk disease, the combination improved OS. The median OS was not yet reached at the time of report at [the meeting]. In addition, it numerically extended progression-free survival by about 3 months, but it did not reach statistical significance…We look forward to hearing further results as the OS endpoint matures, but the landscape is certainly changing for first-line treatment of [patients with] metastatic RCC based on these data.
Importantly, the study showed a complete response (CR) rate of 9% for patients with intermediate- and poor-risk disease in the metastatic setting. We haven't seen this type of CR rate since the era of interleukin-2 studies. This is a promising area of creating durable, lasting responses for our patients, and we are really excited about the opportunities that immunotherapy—particularly the combination of nivolumab plus ipilimumab—affords.
There may be patients who develop treatment resistance at some point, so there are always opportunities to improve upon these response rates. We are currently proposing further studies to build upon the results of CheckMate-214.