From:  Immunotherapy in gynecological cancers

Clinical trials in EC

AuthorTrial/PhaseSettingPts NTreatmentResultsGrade 3–4 AEs Pts N (%)
Marabelle et al., 2020 [47]KEYNOTE-158
Phase II		MSI-H/dMMR relapsed pretreated49Pembrolizumab 200 mg q3w for 2 yearsORR 57.1%

Median DoR
NR (2.9 to 27.0+)		Treatment related:

  • -fatigue n = 2 (0.9)

  • -asthenia n = 1 (0.4)

Immune-mediated:

  • -hyperthyroidism n = 1 (0.4)

  • -pneumonitis n = 3 (1.3)

  • -colitis n = 2 (0.9)

  • -hepatitis n = 2 (0.9)

  • -severe skin reactions n = 3 (1.3)

  • -diabetes mellitus 1 n = 1 (0.4)

  • -Guillain-Barre syndrome n = 1 (0.4)

  • -pancreatitis n = 1 (0.4)

Makker et al., 2019 [31]KEYNOTE-146
Phase II		Metastatic, no more than two prior systemic therapies5320 mg oral lenvatinib daily plus 200 mg pembrolizumab q3wORR 39.6% investigator review

ORR 45.3% independent review		Treatment-related:

  • Grade 3: n = 36 (68)

  • Grade 4: none

Most common:

  • -hypertension n = 18 (34)

  • -diarrhoea n = 4 (8)

  • -palmar-plantar erythrodysesthesia syndrome n = 3 (6)

SGO 2019 Annual meeting [48]GARNET
Phase I		Previously treated recurrent or advanced110Dostarlimab 500 mg q3w for 4 cycles → 1,000 mg q6wORR 27.7% (50.0% in MSI-H; 19.1% in MSS)

DCR 48.9%		Treatment-related:

  • Grade 3–4 n = 13 11.8%

Most common:

  • -AST increased (2.7)

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Pts N: patient number; Mo.: month; NR not reached