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Table 1 Selected trials for monotherapy checkpoint inhibitor and VEGF TKI in unresectable gastroesophageal cancer

From: The integration of immune checkpoint inhibitors with VEGF targeted agents in advanced gastric and gastroesophageal adenocarcinoma: a review on the rationale and results of early phase trials

Trial

Interventions

Phases

Treatment setting

Results

NCT00548548

Bevacizumab + CTx versus CTx

III

1st line

ORR: 46 versus 37%

PFS: 6.7 versus 5.3 mo

OS: 12.1 versus 10.1 mo

Most common grade 3–4 AE: neutropenia (35%), anemia (10%), anorexia (8%)

REGARD

RAINBOW

Ramucirumab versus BSC

Ramucirumab + CTx versus CTx

III

2nd line

OS:

Ramucirumab versus BSC: 5.2 versus 3.8 mo

Ramucirumab + CTx versus CTx: 9.6 versus 7.4 mo

Grade 3–4 AEs: 57% versus 58% (REGARD)

Grade 3–4 AEs: 47% versus 42% (RAINBOW)

INTEGRATE

Regorafenib versus placebo

II

2 or fewer lines of Tx

PFS: 2.6 versus 0.9 mo

Grade 3–4 AE: 67% versus 52%

NCT00940225

Cabozantinib

II

Advanced, recurrent, or metastatic

ORR: 10%

DCR: 33%

Grade 3–4 AE: 74.5%

KEYNOTE-59

Pembrolizumab

II

3rd line

PD-L1 + 

ORR: 15.5%

mDOR: 16.3 mo

Grade 3–5 AE: 17.8%

KEYNOTE-62

Pembrolizumab or Pembrolizumab + CTx versus CTx

III

1st line

mOS: 10.6 versus 11.1 mo (CPS 1 or higher)

PFS: 6.9 versus 6.4 mo (CPS 1 or higher)

Grade 3–4 AE: 17% versus 73% versus 69% (Pembro versus Pembro + CTx versus CTx)

KEYNOTE-180

Pembrolizumab

II

3rd line

Overall ORR: 9.9%

mDOR: NR (1.9–14.4 mo)

Grade 3–4 AE: 12.4%

KEYNOTE-61

Pembrolizumab versus Paclitaxel

III

2nd line

mOS: 9.1 versus 8.3 mo

mPFS: 1.5 versus 4.1 mo

Grade 3–5 AE: 14% versus 35%

KEYNOTE-181

Pembrolizumab versus CTx

III

2nd line

mOS: 9.3 versus 6.7 mo (CPS 10 or higher)

Grade 3–5 AE: 18.2% versus 40.9%

KEYNOTE-590

Pembrolizumab + CTx versus CTx

III

1st line

mOS: 12.4 versus 9.8 mo

mDOR: 8.3 versus 6.0 mo

Discontinuation rates due to AEs: 19% versus 12%

CheckMate-649

Nivolumab + CTx versus CTx

III

1st line

mOS: 13.8 versus 11.6 mo (overall)

mOS: 14.0 versus 11.3 mo (CPS 1 or higher)

mOS: 14.4 versus 11.1 mo (CPS 5 or higher)

Grade 3–4 AEs: 59% versus 44%

CheckMate-32

Nivolumab w/wo ipilimumab

I/II

2nd line

ORR 12%, 24%

12-mo OS: 39%, 35%

Grade 3–4 AEs: 17% versus 47% versus 27%*

ATTRACTION-2

Nivolumab versus placebo

III

2nd line

mOS: 5.3 versus 4.1 mo

12-mo OS: 26.2 versus 10.9%

Grade 3–4 AEs: 10% versus 4%

JAVELIN Gastric 300

Avelumab versus CTx

III

3rd line

mOS: 4.6 versus 5.0 mo

PFS: 1.4 versus 2.7 mo

ORR: 2.2 versus 4.3%

Grade 3–4 AEs: 9.2% versus 31.6%

NCT02340975

Durvalumab w/wo ipilimumab

I/II

2nd line

ORR: 0%, 7.4%

12 mo OS: 4.6%, 37%

Grade 3–4 AEs: 17% versus 4%, versus 42% versus 16%**

  1. *Nivolumab only versus Nivolumab 1 mg/kg + ipilimumab 3 mg/kg versus nivolumab 3 mg/kg + ipilimumab 1 mg/kg
  2. **Durvalumab + tremelimumab in 2nd line setting versus durvalumab only versus trememlimumab only versus durvalumab + tremelimumab in 3rd line setting