Clinical trials in EC

Author Trial/Phase Setting Pts N Treatment Results Grade 3–4 AEs Pts N (%)
Marabelle et al., 2020 [47] KEYNOTE-158
Phase II
MSI-H/dMMR relapsed pretreated 49 Pembrolizumab 200 mg q3w for 2 years ORR 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 therapies 53 20 mg oral lenvatinib daily plus 200 mg pembrolizumab q3w ORR 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 advanced 110 Dostarlimab 500 mg q3w for 4 cycles → 1,000 mg q6w ORR 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)

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