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Table 3 ICI combination therapy for advanced HCC

From: Recent advances in systemic therapy for hepatocellular carcinoma

Regimen

Setting

Phase

Name/NCT No.

Results

Approval Status

ICI + MKI

Nivolumab + Ipilimumab

2nd

I/II

CheckMate-040

ORR 32%, DCR 54%, mOS 22.2 months

Conditional second-line, 2020

1st

III

CheckMate-9DW

/

/

Nivolumab + Sorafenib

1st

II

NCT03439891

/

/

Nivolumab + Lenvatinib

1st

Ib

NCT03418922

/

/

Nivolumab + BMS986253

1st

II

NCT04050462

/

/

Nivolumab + Mogamulizumab

2nd

I/II

NCT02705105

/

/

Nivolumab + Galunisertib

2nd

Ib/II

NCT02423343

/

/

Nivolumab + Relatlimab

2nd

II

NCT04567615

/

/

Nivolumab + Cabozantinib

neoadjuvant

Ib

CaboNivo/NCT03299946

/

/

Pembrolizumab + Regorafenib

1st

Ib

NCT03347292

/

/

Pembrolizumab + Lenvatinib

1st

Ib

KEYNOTE524/NCT03006926

ORR 46%, mPFS 9.3 months, mOS 22 months

/

1st

III

LEAP-002/NCT03713593

/

/

Atezolizumab + Bevacizumab

1st

Ib

GO30140

ORR 36%, mPFS 5.6 vs. 3.4 months

(compared to atezolizumab monotherapy, p=0.011)

/

1st

III

IMbrave150

ORR 29.8%, mOS 19.2 vs. 13.4 months

(compared to sorafenib, HR 0.66, p=0.0009)

First-line treatment, 2020

Atezolizumab + Cabozantinib

1st

III

COSMIC-312/NCT03755791

/

/

Avelumab + Axitinib

1st

I

NCT03289533

ORR 31.8%, mPFS 3.8 months

/

Avelumab + Regorafenib

2nd

I/II

REGOMUNE/NCT03475953

/

/

Durvalumab + Cabozantinib

2nd

Ib

NCT03539822 (CAMILLA)

/

/

Durvalumab + Ramucirumab

2nd

I

NCT02572687

/

/

Durvalumab + tivozanib

1st

Ib/ II

DEDUCTIVE/NCT03970616

Ib: 2 of 7 achieving PR

/

Camrelizumab + Apatinib

1st

I

NCT02942329

ORR 50%, mPFS 5.8 months

/

2nd

II

RESCUE/ NCT03463876

/

/

1st

III

NCT03764293

/

/

Emibetuzumab + amucirumab

2nd

I/II

NCT02082210

/

/

ICI + ICI

     

IBI310 + Sintilimab

1st

III

NCT04720716

/

/

Durvalumab + Tremelimumab

1st/2nd

I/II

NCT02519348

ORR 24%, mOS 18.7 months

/

1st

III

HIMALAYA/NCT03298451

/

/

  1. Abbreviations: ICI immune checkpoint inhibitor, MKI multikinase inhibitor, ORR objective response rate, mOS median overall survival, mPFS median progression-free survival, mTTP median time to progression, PR partial response