Results from the phase 3 clinical trial KEYNOTE-775, recently published on New England Journal of Medicine, shows that a combination between the tyrosine kinase inhibitor lanvatinib and the anti-PD-1 pembrolizumab led to a significantly longer progression-free and overall survival than the physician’s choice of chemotherapy in patients with advanced endometrial cancer.
The trail enrolled a total of 827 patient progressed or recurred after at least one platinum-based chemotherapy regimen; participants received either 20 mg of lenvatinib orally once daily plus 200 mg of pembrolizumab intravenously every 3 weeks or physicians choice chemotherapy. After a median follow-up of 10-12 months, the overall population had an objective response of 31.9% in the combination group and 14.7% in the chemotherapy group; the complete response rate was 6.6% and 2.6%, respectively; the median duration of response was 14.4 months with the combination and 5.7 months with chemotherapy. Patients in the combination group experienced tumor shrinkage and improvement in efficacy across all end points compared with the chemotherapy group: the median progression-free survival was 7.2 months in the combination group and 3.8 months in the chemotherapy group, the median overall survival was 18.3 months vs 11.4 months in the combination and chemotherapy groups, respectively. In the combination group, 66.5% of patients had adverse events that led to dose reduction, 69.2% led to dose interruptions, and 33.0% led to discontinuation. «These benefits in progression-free survival and overall survival were seen across all evaluated subgroups, including subgroups defined according to less-common yet aggressive histologic features, history of pelvic irradiation, and previous lines of therapy» the authors conclude.