KEYNOTE-942 is a randomised phase II trial of pembrolizumab alone or pembrolizumab plus intismeran, a personalised neoadjuvant therapy, in high-risk resected melanoma, really seeing if the addition of intismeran to pembrolizumab can reduce the risk of recurrence.

Could you outline the methodology?

It was an open label, so non-blinded, study randomised 2:1. So we took patients who had had resected stage, high-risk, stage III or IV, melanoma. All those patients needed to have available tissue to determine they could make the intismeran product and once that was confirmed that we could in fact make intismeran for those patients they were randomised 2:1 to either open-label pembrolizumab alone or the combination. Every patient got a year of pembrolizumab and the patients on the combination arm got nine doses of intismeran along with the pembrolizumab.

What did you find?

We found that the addition of intismeran to pembrolizumab reduced the risk of recurrence and also reduced the risk of distant recurrence by 49% and 59% respectively.

What’s next?

This is quite a provoking study because there’s quite a significant difference and there’s also a lot of translational data showing why the intismeran works and that the immune system is responding to the intismeran neoadjuvant. However, it needs confirmation and so the confirmation is a randomised phase III study with a larger melanoma population, including stage II, III and IV patients. That study has actually completed enrolment and results are hopefully awaited some time soon.