TEAE-related dose reductions occurred in 66.5 and 12.9 percent, respectively, and discontinuations in 33.0 and 8.0 percent, respectively.Īmong lenvatinib + pembrolizumab recipients, 30.8 percent of patients discontinued lenvatinib, 18.7 percent discontinued pembrolizumab, and 14.0 percent discontinued both drugs due to TEAEs. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 88.9 and 72.7 percent of patients in the lenvatinib + pembrolizumab and TPC groups, respectively. Patients in the lenvatinib + pembrolizumab and TPC groups were treated for a median 231 and 104.5 days, respectively. Median duration of response was 9.2 vs 5.7 months (pMMR) and 14.4 vs 5.7 months (overall), while median time to response was 2.1 vs 3.5 months in the pMMR population and 2.1 months in both groups in the overall population. Complete and partial response rates were also twofold in the lenvatinib + pembrolizumab vs TPC groups in both the pMMR and overall populations. Objective response rate (ORR) was twofold in the lenvatinib + pembrolizumab vs TPC group in the pMMR (30.3 percent vs 15.1 percent) and overall population (31.9 percent vs 14.7 percent p<0.0001 for both). The PFS and OS benefits with lenvatinib + pembrolizumab over TPC were consistent in various subgroups analysed including histology and number of prior treatments. ![]() There was also a significant improvement in overall survival (OS) with lenvatinib + pembrolizumab compared with TPC in both the pMMR (median 17.4 vs 12.0 months HR, 0.68, 95 percent CI, 0.56–0.84 p=0.0001) and overall populations (median 18.3 vs 11.4 months HR, 0.62, 95 percent CI, 0.51–0.75 p<0.0001). Progression-free survival (PFS) was significantly longer with lenvatinib + pembrolizumab compared with TPC in both the pMMR (median 6.6 vs 3.8 months hazard ratio, 0.60, 95 percent confidence interval, 0.50–0.72) and the overall population (median 7.2 vs 3.8 months HR, 0.56, 95 percent CI, 0.47–0.66 p<0.0001 for both). Median follow-up for the lenvatinib + pembrolizumab group was 12.2 months, and 10.7 months for the TPC group. Endometrioid carcinoma was the most common histology (~60 percent), followed by serous carcinoma. ![]() Of these, 697 and 130 were DNA mismatch repair-proficient (pMMR) and -deficient (dMMR), respectively.īaseline characteristics (age, race, ECOG status, and prior pelvic radiation exposure) were comparable between groups. In patients with advanced endometrial cancer with prior platinum chemotherapy exposure, a combination of lenvatinib + pembrolizumab improved survival compared with physician’s choice of treatment (TPC), results of the phase III Study 309/KEYNOTE-775 trial showed.Ī total of 827 patients with advanced, metastatic, or recurrent endometrial cancer, prior exposure to platinum-based therapy*, and ECOG performance score 0–1 were randomized 1:1 to receive oral lenvatinib (20 mg QD) + intravenous (IV) pembrolizumab (200 mg Q3W for ≤35 doses) or TPC (IV paclitaxel 80 mg/m 2 QW or doxorubicin 60 mg/m 2 Q3W ).
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