Table 2 Clinical trials of ICIs, ADCs, and their combined application in UC.

From: The combination of immune checkpoint inhibitors and antibody-drug conjugates in the treatment of urogenital tumors: a review insights from phase 2 and 3 studies

Categories

Clinical trials

Phases

Patients

Drugs

Targets

Clinical outcomes

References

ICIs

KEYNOTE-045

3

52 la/mUC

Pemb

PD-1

Pemb vs. Chem: 2-year OS: 26.9% vs. 14.3%; PFS: 2.0 m vs. 4.9 m; ORR: 20.0% vs. 18.2%.

[55]

KEYNOTE-052

2

370 mUC

Pemb

PD-1

Pemb appeared to be consistent regardless of age and/or status.

[56]

KEYNOTE-057

2

334 NMIBC

Pemb

PD-1

Pemb was tolerable and showed promising anti-tumor activity.

[57]

KEYNOTE-361

3

1010 aUC

Pemb

PD-1

PFS changed little; mPFS: 8.3 m vs. 7.1 m; mOS: 17.0 m vs. 14.3 m.

[58]

POLARIS-03

2

151 mUC

Tori

PD-1

ORR: 26% with a DCR of 45%; mDR, PFS, and OS: 19.7 m, 2.3 m, and 14.4 m.

[59]

NCT02527434

2

32 la/mUC

Tori

PD-1

ORR:18.8%, including CR: 6.3%, and PR: 12.5%.

[60]

CheckMate 275

2

270 mUC

Nivo

PD-1

mOS:7.0 m.

[61]

SWOGS1605

2

172 NMIBC

Atez

PD-L1

27% experienced a CR at 6.0 m; mDR: 17.0 m.

[63]

IMvigor 211

3

127 la/mUC

Atez

PD-L1

mOS: 9.2 m vs. 7.7 m.

[64]

IMvigor 210

2

123 la/mUC

Atez

PD-L1

ORR: 23%; CRR: 9%; mOS: 15.9 m.

[65]

IMvigor130

3

1213 la/mUC

(A)Atez+C; (B)Atez; (C)C

PD-L1 + C

mPFS: 8.2 m(A), 6.3 m(C); mOS: 16.0 m(A), 13.4 m(C); mOS: 15.7 m(B).

[66]

NCT02792192

2

24 NMIBC

Atez + BCG

PD-L1 + Immune targets

Atez + BCG was well-tolerated.

[67]

NCT02516241

3

1032 la/mUC

Durv + Trem

PD-L1 + CTLA-4

This study did not meet either of its co-primary endpoints.

[70]

ADCs

RC48-C005

2

43 mUC

RC48-ADC

HER-2

ORR: 51.2%; mPFS: 6.9 m; OS: 13.9 m.

[75]

KAMELEON

2

20 BC

T-DM1

HER-2

5 patients exhibited a PR; ORR: 38.5%.

[77]

NCT01631552

2

515 cancers (including mUC)

SG

TROP-2

TRAEs: nausea (62.6%), diarrhea (56.2%), fatigue (48.3%), alopecia (40.4%), and neutropenia (57.8%).

[80]

TROPHY-U-01

2

113 la/mUC

SG

TROP-2

ORR: 27%; MD of response: 7.2 m; mPFS: 5.4 m; OS: 10.9 m.

[81]

NCT00462488

2

46 BC

OM

EpCAM

44% achieved a CR; Median time to recurrence: 274 and 408 days.

[85]

EV301

3

608 la/mUC

EV

Nectin-4

EV vs. C: mOS: 12.88 m vs. 8.97 m; mPFS: 5.55 m vs. 3.71 m.

[86]

EV201

2

219 la/mUC

EV

Nectin-4

ORR: 52%; 20% achieved a CR; 31% achieved a PR.

[88]

ICIs+ADCs

EV103 Cohort K

2

149 la/mUC

Pemb + EV

PD-1 + Nectin-4

ORR: 64.5% vs. 45.2%; mDOR of EV: 13.2 m.

[91]

EV-302

3

45 la/mUC

Pemb + EV

PD-1 + Nectin-4

ORR: 73.3%; RR: 15.6%; mDOR: 25.6 m; mOS: 26.1 m.

[92]

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