Table 2

Clinical trials evaluating anti-programmed death 1/programmed death ligand 1 therapies in patients with previously treated endometrial cancer

StudyPhaseTherapyDiseasePrevious therapyBiomarkersNObjective response rate (%)
KEYNOTE-02812 1bPembrolizumab
(anti-PD-1)
Locally advanced or metastatic endometrial cancerPatients had disease that had progressed after standard therapy, or for which no standard therapy exists, or for which standard therapy is not appropriatePD-L1-positive24 (23 in efficacy analysis)13.0% (RECIST v1.1 by investigator review)
KEYNOTE-1588 2Pembrolizumab
(anti-PD-1)
Unresectable and/or metastatic incurable endometrial carcinomaPatients had disease that had progressed on or was intolerant to previous standard therapyMSI-H/dMMR4957.1% (RECIST v1.1 by independent central radiologic review)
GARNET14 1Dostarlimab
(anti-PD-1)
Recurrent or advanced endometrial cancerPatients had disease that had progressed during or after chemotherapy with ≤2 previous lines of therapydMMR11045.5% (RECIST v1.1 by blinded independent central review)
pMMR14413.9% (immune-related RECIST by investigator assessment)
PHAEDRA (ANZGOG1601)15 2Durvalumab
(anti-PD-L1)
Advanced endometrial cancerPatients had disease that had progressed after 0–3 previous lines of chemotherapydMMR3540% (immune-related RECIST)
Patients had disease that had progressed after 1–3 previous lines of chemotherapypMMR363% (immune-related RECIST)
NCT0291257216 2Avelumab
(anti-PD-L1)
Recurrent endometrial cancerPatients had received ≥1 previous lines of chemotherapydMMR1526.7% (RECIST v1.1)
pMMR166.25% (RECIST v1.1)
KEYNOTE-146/
Study 11110
1b/2Pembrolizumab + lenvatinib
(anti-PD-1 + tyrosine kinase inhibitor)
Advanced endometrial cancerPatients had received ≤2 previous lines of systemic therapy (≥2 lines allowed at sponsor’s discretion)dMMR or pMMR12439.5% (immune-related RECIST by investigator assessment)
dMMR1163.6% (immune-related RECIST by investigator assessment)
pMMR9436.2% (immune-related RECIST by investigator assessment)
KEYNOTE-775/
Study 30911
3Pembrolizumab + lenvatinib
(anti-PD-1 + tyrosine kinase inhibitor) vs
doxorubicin or paclitaxel
Advanced endometrial cancerPatients had received 1‒2 previous platinum-based chemotherapy regimens (including neoadjuvant/adjuvant)dMMR or pMMR82731.9% vs 14.7% (RECIST v1.1 by blinded independent central review)
pMMR69730.3% vs 15.1% (RECIST v1.1 by blinded independent central review)
  • dMMR, mismatch repair-deficient; MSI-H, microsatellite instability high; PD-1, programmed death 1; PD-L1, programmed death ligand 1; pMMR, mismatch repair-proficient; RECIST, Response Evaluation Criteria in Solid Tumors.