Table 1 HER2-directed immunotherapy trials under development.

From: Clinical development of immunotherapies for HER2+ breast cancer: a review of HER2-directed monoclonal antibodies and beyond

Compound

Classification

Study phase

Patient population

HER2 1-2+, non-amplified allowed, y/n

Lines of therapy, no.

Study population (n), no.

NCT ID

HER2-directed mab

 MCLA-128

HER2/HER2 mAb

2

HER2+ LAD or MBC

Yes

>1

120

03321981

 GBR 1302

CD3 bispecific mAb

1/2

HER2+ LAD or MBC

No

>1

158

03983395

HER2-directed ADC

 RC48

HER2 ADC

1b/2

HER2+ LAD or MBC

No

>1

165

03052634

 DS-8201a

HER2 ADC

3

HER2+ LAD or MBC

No

>1

600

03523585

 DS-8201a

HER2 ADC

3

HER2+ LAD or MBC

No

>1

500

03529110

 DS-8201a

HER2 ADC

3

HER2+ LAD or MBC

Yes

>1

540

03734029

 RC48

HER2 ADC

1b/2

HER2+ LAD or MBC

No

>1

165

03052634

 FS-1502

HER2 ADC

1

HER2+ LAD or MBC

Yes

>1

92

03944499

 SYD985

HER2 ADC

2

HER2+ LAD or MBC

No

>2

345

03262935

 ARX788

HER2 ADC

1

HER2+ LAD or MBC

Yes

>1

60

03255070

PD-1/PD-L1 immune checkpoint inhibitors

 Pembrolizumab

PD-1 mAb

1b

HER2+ LAD or MBC

No

>1

27

03032107

 Pembrolizuab

PD-1 mAb

2

HER2+ stage I-III

No

0

174

03747120

 Atezolizumab

PD-L1 mAb

1b

HER2+ LAD or MBC

Yes

>1

98

02605915

 Atezolizumab

PD-L1 mAb

3

HER2+ LAD or MBC

No

>1

6000

03199885

 Atezolizumab

PD-L1 mAb

2a

HER2+ LAD or MBC

No

0

50

03125928

 Atezolizumab

PD-L1 mAb

3

HER2+ stage I-III

No

0

453

03726879

 Atezolizumab

PD-L1 mAb

2

HER2+ MBC with CNS involvement

No

33

03417544

 KN035

PD-L1 mAb

2

HER2+ LAD or MBC

NR

>1

59

04034823

Cytokine directed therapies

 IFN-γ

Th1 cytokine

2

HER2+ stage I-III

No

N/A

43

03112590

 Tocilizumab

IL-6 receptor inhibitor mAb

1

HER2+ LAD or MBC

No

>1

20

03135171

 Utomilumab

Receptor co-stimulatory of TNF mAb

1b

HER2+ LAD or MBC

No

>1

79

03364348

 Utomilumab

Receptor co-stimulatory of TNF mAb

2

HER2+ LAD or MBC

No

>1

100

03414658

CAR-T-cell

 CAR T-cell

Anti-HER2 CAR T-cell NOS

1/2

HER2+ LAD or MBC

NR

>1

60

02713984

  1. Trials listed at www.clinicaltrials.gov as of 22 August 2019.
  2. ADC antibody-drug conjugate, CAR-T Chimeric antigen receptor T-cell, CNS central nervous system, LAD locally advanced disease, mAb monoclonal antibody, MBC metastatic breast cancer, NCT National Clinical Trial, NOS not otherwise specified, NR no response, TNF tissue necrosis factor.