KEYNOTE-426 was a global phase III trial that looked at the combination of axitinib, a very potent VEGF receptor inhibitor, and pembrolizumab, a PD-1 inhibitor, in patients with previously untreated advanced kidney cancer compared to sunitinib. As you may know, there are six of these phase III trials going on with an immune agent and a VEGF agent or an immune agent plus an immune agent – ipilimumab plus nivolumab – compared to Sutent as a control; this is one of those trials, obviously.
There had been a phase I trial that showed very robust activity: 70% response rate, over a 20 month progression free survival, almost unbelievable activity, and therefore this phase III was conducted. It was over 800 patients, again globally, and the results really were quite astounding. The hazard ratio for survival in favour of what we call axi-pembro is 0.53, so almost a halving of the risk of dying, 47% reduction, for patients who got randomised the combo. There were also advantages in progression free survival, about 15 versus 11 months, and response rate, a nearly 60% response rate. So the robust activity from the phase I/II held up and it translated into a very impressive survival. It’s the first time in kidney cancer ever in a front line setting that all three of those endpoints have been met.
This is going to be the new standard of care. Ipi-nivo is currently the standard of care and this is going to assume a large part of the standard of care, I think, one of those two regimens. More broadly speaking it means that kidney cancer patients walking in the door, they’re all going to get an IO-based combo. The days of giving TKI monotherapy are pretty much over.