Objectives In Study 309/KEYNOTE-775, lenvatinib + pembrolizumab (LEN+pembro) significantly improved PFS, OS, and ORR versus treatment of physician’s choice (TPC) in aEC patients with DNA mismatch repair proficient tumors and all-comers following platinum-based therapy. We report results for dMMR aEC patients.
Methods Patients in Study 309/KEYNOTE-775 were randomized 1:1 to lenvatinib 20 mg orally daily + pembrolizumab 200 mg IV Q3W or TPC (doxorubicin 60 mg/m2 IV Q3W or paclitaxel 80 mg/m2 IV QW [3 weeks on/1 week off]). Patients had aEC with 1 prior platinum-based chemotherapy regimen (2 if one was given in the neoadjuvant/adjuvant setting). Prespecified efficacy (PFS, OS, and ORR) and safety analyses among dMMR patients are reported. P-values are nominal. Tumors were assessed by blinded independent central review per RECIST v1.1.
Results 130 Patients with dMMR aEC were randomized to LEN+pembro (n=65) or TPC (n=65). Median follow-up was 13.5 months for the LEN+pembro group and 8.8 months for the TPC group (data cutoff: October 26, 2020). PFS (median 10.7 vs 3.7 months) and OS (median not reached vs 8.6 months) were longer with LEN+pembro vs TPC. ORR was greater with LEN+pembro (40.0%) vs TPC (12.3%). Additional results are in the Table. Grade ≥3 treatment-emergent adverse events occurred in 95% and 73% of patients in the LEN+pembro and TPC groups, respectively.
Conclusions LEN+pembro improved PFS, OS, and ORR vs TPC in patients with dMMR aEC, with a manageable safety profile generally consistent with all-comers and previous studies.
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