Table 1 Clinical trials investigating immunotherapy-based regimens in patients with advanced soft-tissue sarcomas (ASCO 2023)

7

LMS

First line

Ib

Doxorubicin 75mg/m² D1 + DTIC 400mg/m² D1-D2 + Nivolumab (240mg/360mg) D2 q3w for 6 cycles Followed by Nivolumab q3w 1 year as maintenance

16

9 (56.2%)

8.7

–

20% G3 Anemia 30% G3-4 Neutropenia 5% (n = 1) G3 Febrile neutropenia

5

All

First or Second line (no prior anthracycline/ICB)

II

Balsitilimab (αPD-1) 300mg q3w for 2 years Zalifrelimab (αCTLA-4) 1mg/kg q6w 4 cycles Doxorubicin 75mg/m² q3w 6 cycles start at C1 (stage 2, n = 14) or C2 (stage 1, n = 19)

33

10 (33.3%)

5.6

14.5

12% G3 + irAE (2 colitis)

13

LMS

First or Second line (no prior anthracycline)

Ib

TTI-621 (αCD47 IgG1) 0.2mg/kg D1, D8—q3w Doxorubicin 75mg/m² q3w up to 6 cycles

23

5 (21.7%)

–

–

8.7% G3 + Anemia 43.5% G3 + Neutropenia 4.3% (n = 1) G3 + Febrile neutropenia 4.3% (n = 1) G3 + pancreatitis

10

All

Second line and beyond

II

Arm A: cabozantinib 60 mg daily

vs

Arm B: Cabozantinib 40 mg daily + Ipililumab (1mg/kg) + Nivolumab (3 mg/jg) q3w for 4 cycles Followed by Cabozantinib 40 mg daily plus Nivolumab 480 mg q4w 1 year as maintenance

Arm A: 36

Arm B: 69

Arm A:

2 (6%)

Arm B:

7 (11%)

Arm A: 3.75

Arm B: 5.36

Arm A:

22.6

Arm B: not reached

15.9% G3 Liver enzymes increase

8

Angiosarcomas

Previously treated with taxanes

(ICB and VEGFR-TKI naive)

II

Nivolumab 480mg q4w Cabozantinib 40mg daily

22

13 (59.0%)

9.6

NR

36.4% G3 + TRAE