The median duration of response (DOR) was 9.2 months versus 5.7 months with the combination and chemotherapy, respectively.Īmong all patients, the ORR was 31.9% with the combination regimen and 14.7% with chemotherapy ( P <. 0001) complete responses were observed in 5.2% and 2.6% of patients, respectively. Objective response rate (ORR) was 30.3% with the combination in pMMR patients treated with the immunotherapy/TKI regimen versus 15.1% with chemotherapy ( P <. Median progression-free survival (PFS) with the combination was 6.6 months versus 3.8 months with chemotherapy in pMMR patients (HR, 0.60 95% CI, 0.50-0.72 P <. Amongst all patients, the median OS was 18.3 months with pembrolizumab and lenvatinib as compared with 11.4 months with chemotherapy (HR, 0.62 95% CI, 0.51-0.75 P <. The immunotherapy/tyrosine kinase inhibitor (TKI) combination led to a median overall survival (OS) of 17.4 months in patients with mismatch repair proficient (pMMR) disease versus 12.0 months with chemotherapy, resulting in a 32% improvement in the risk of death (HR, 0.68 95% CI, 0.56-0.84 P <.
#Keynote 775 trial#
“This approval is an important step forward in helping patients fight this difficult-to-treat malignancy, as physicians can now provide an option that may improve survival outcomes.”Īpproval for the combination was based on findings from the pivotal phase 3 KEYNOTE-775/Study 309 trial (NCT03517449).
“With a five-year survival rate of just 17%, women with advanced endometrial cancer who are not candidates for curative therapy, particularly those with disease progression following prior systemic therapy, have limited treatment options,” said principal investigator Vicky Makker, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, in a statement. The FDA has approved the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced endometrial cancer that is not microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic treatment and who are not candidates for curative surgery or radiation.1
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