The KEYNOTE-716 study is an adjuvant study of pembrolizumab versus placebo in resected stage 2b and 2c melanoma. This is a phase III randomised trial comparing 12 months of pembrolizumab versus 12 months of placebo to reduce the risk of recurrence in patients with resected stage 2b or 2c melanoma. These patients, the natural history is that many recur by 24 months and after and these patients do not do well. So giving 12 months of pembrolizumab our goal, our hypothesis, was that it would reduce the risk of recurrence.
We found that pembrolizumab indeed did reduce the risk of recurrence but at ASCO 2022 I also presented the first analysis of the distant metastasis free survival. This is very important because distant metastases are what causes death from cancer, from melanoma. We found that pembrolizumab significantly reduces the risk of distant metastasis with a hazard ratio of 0.64, that’s a 36% reduction in the risk of distant metastasis compared with placebo. The p-value was highly significant, it was a p-value of 0.0029 and, furthermore, the 12 month and 24 month distant metastasis free survival rates were higher in the pembrolizumab arm versus the placebo arm.
We also gave an update on the relapse free survival and we showed a sustained improvement in the relapse free survival of pembrolizumab given adjuvantly compared with placebo. Looking at all the subgroups, the key subgroups, they all favoured pembrolizumab compared with placebo, including the highest risk and that is T sub-stage T4b.
So the summary analysis from this very latest analysis, it’s actually the third interim analysis but the first analysis of distant metastasis free survival, is that indeed pembrolizumab 12 months after resection, complete resection of stage 2b and 2c melanoma, reduces both the risk of recurrence and, importantly, the distant metastases.