Table 2.
Clinical trials evaluating anti-programmed death 1/programmed death ligand 1 therapies in patients with previously treated endometrial cancer
| Study | Phase | Therapy | Disease | Previous therapy | Biomarkers | N | Objective response rate (%) |
| KEYNOTE-02812 | 1b | Pembrolizumab (anti-PD-1) |
Locally advanced or metastatic endometrial cancer | Patients had disease that had progressed after standard therapy, or for which no standard therapy exists, or for which standard therapy is not appropriate | PD-L1-positive | 24 (23 in efficacy analysis) | 13.0% (RECIST v1.1 by investigator review) |
| KEYNOTE-1588 | 2 | Pembrolizumab (anti-PD-1) |
Unresectable and/or metastatic incurable endometrial carcinoma | Patients had disease that had progressed on or was intolerant to previous standard therapy | MSI-H/dMMR | 49 | 57.1% (RECIST v1.1 by independent central radiologic review) |
| GARNET14 | 1 | Dostarlimab (anti-PD-1) |
Recurrent or advanced endometrial cancer | Patients had disease that had progressed during or after chemotherapy with ≤2 previous lines of therapy | dMMR | 110 | 45.5% (RECIST v1.1 by blinded independent central review) |
| pMMR | 144 | 13.9% (immune-related RECIST by investigator assessment) | |||||
| PHAEDRA (ANZGOG1601)15 | 2 | Durvalumab (anti-PD-L1) |
Advanced endometrial cancer | Patients had disease that had progressed after 0–3 previous lines of chemotherapy | dMMR | 35 | 40% (immune-related RECIST) |
| Patients had disease that had progressed after 1–3 previous lines of chemotherapy | pMMR | 36 | 3% (immune-related RECIST) | ||||
| NCT0291257216 | 2 | Avelumab (anti-PD-L1) |
Recurrent endometrial cancer | Patients had received ≥1 previous lines of chemotherapy | dMMR | 15 | 26.7% (RECIST v1.1) |
| pMMR | 16 | 6.25% (RECIST v1.1) | |||||
| KEYNOTE-146/ Study 11110 |
1b/2 | Pembrolizumab + lenvatinib (anti-PD-1 + tyrosine kinase inhibitor) |
Advanced endometrial cancer | Patients had received ≤2 previous lines of systemic therapy (≥2 lines allowed at sponsor’s discretion) | dMMR or pMMR | 124 | 39.5% (immune-related RECIST by investigator assessment) |
| dMMR | 11 | 63.6% (immune-related RECIST by investigator assessment) | |||||
| pMMR | 94 | 36.2% (immune-related RECIST by investigator assessment) | |||||
| KEYNOTE-775/ Study 30911 |
3 | Pembrolizumab + lenvatinib (anti-PD-1 + tyrosine kinase inhibitor) vs doxorubicin or paclitaxel |
Advanced endometrial cancer | Patients had received 1‒2 previous platinum-based chemotherapy regimens (including neoadjuvant/adjuvant) | dMMR or pMMR | 827 | 31.9% vs 14.7% (RECIST v1.1 by blinded independent central review) |
| pMMR | 697 | 30.3% 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.