Table 5 Overall summary of AEs (safety population as of July 7, 2023)

From: Dostarlimab or pembrolizumab plus chemotherapy in previously untreated metastatic non-squamous non-small cell lung cancer: the randomized PERLA phase II trial

AE (n, %)

Dostarlimab + chemotherapy (N = 121)

Pembrolizumab + chemotherapy (N = 122)

AEs

119 (98)

119 (98)

TRAEs

103 (85)

99 (81)

Dostarlimab or pembrolizumab-related AEs

86 (71)

70 (57)

Grade ≥3 AEs

78 (64)

78 (64)

Grade ≥3 TRAEs

78 (64)

77 (63)

AEs leading to treatment discontinuation

35 (29)

46 (38)

Dostarlimab or pembrolizumab-related AEs leading to treatment discontinuation

20 (17)

29 (24)

SAEs

50 (41)

58 (48)

Dostarlimab or pembrolizumab-related SAEs

14 (12)

17 (14)

Fatal AEsa

15 (12)

12 (10)

Fatal TRAEb

3 (2)

5 (4)

 Immune-mediated lung disease

1 (<1)

0

 Myelosuppression

0

1 (<1)

 Pneumonia

0

1 (<1)

 Pneumonitis

1 (<1)

0

 Septic shock

0

1 (<1)

 Thrombocytopenia

0

1 (<1)

Fatal dostarlimab or pembrolizumab-related AEs

3 (2)c

2 (2)d

irAEse

38 (31)

47 (39)

irSAEs

12 (10)

11 (9)

  1. AE adverse event, ir immune-related, SAE serious adverse event, TRAE treatment-related adverse event.
  2. aPatients who had a fatal AE recorded and death was not recorded as due unequivocally to disease under study.
  3. bAEs described as treatment-related could be related to any study treatment agent.
  4. cPneumonitis; immune-related pneumonitis, urosepsis.
  5. dMyelosuppression, respiratory failure.
  6. eNo new immune-related deaths were observed.
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