Table Info

Table 2.

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)

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

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

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

Declarations

Author contributions

DL contributed to conception and design of the study; VC wrote the first draft of the manuscript; GD, AP, VS, MM, CN, FC, GS wrote sections of the manuscript. All authors contributed to manuscript revision, read and approved the submitted version.

Conflicts of interest

VC, MM, CN, FC declare that they have no conflicts of interest. Outside the submitted work:

DL has served on advisory boards for Clovis Oncology, AstraZeneca, Genmab/Seattle Genetics, MSD, ImmunoGen, PharmaMar, Roche, and Tesaro/GSK, received support for travel or accommodation from AstraZeneca, GSK and Roche and institutional research funding from Merck, GSK, Clovis, Pharmamar.

GD has served on advisory board of Beigene and received support for travel and accomodation from Roche.

VS has served on advisory board of Roche, Astra Zeneca, MSD, GSK and Clovis and received support for travel and accomodation from Pharmamar, GSK, Roche.

AP worked at Astra Zeneca Medical Affair Division until Dec 2018.

GS has served on advisory boards for TESARO Bio Italy S.r.l, Johnson & Johnson, Clovis Oncology Italy S.r.l. He received support for travel or accommodation from MSD Italy S.r.l and Clovis Oncology Italy S.r.l, and institutional research funding from MSD Italy S.r.l.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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