Table 3.

Association between mild (i.e., grade 1–2) or severe (i.e., grade 3–5) immune-related adverse events and progression-free survival or overall survival in all patients, and 12-week landmark and 24-week landmark cohorts. n/r = not reached. Bold/italics represent statistically significant findings (p < 0.005).

	PFS	HR	p	OS	HR	p
All
No irAE	3.6 (1.3–13.1)	ref	ref	7.8 (2.4–20.5)	ref	ref
Severe irAE	7.8 (2.2–20.2)	0.61 (0.40–0.94)	0.024	16.1 (7.3–34.3)	0.55 (0.35–0.86)	0.008
Mild irAE	24.7 (8.1-n/r)	0.32 (0.22–0.48)	<0.001	35.3 (19.7-n/r)	0.27 (0.18–0.42)	<0.001
12-week Landmark
No irAE	9.8 (4.4–23.0)	ref	ref	11.7 (6.8–30.5)	ref	ref
Severe irAE	14.3 (7.0-n/r)	0.64 (0.38–1.08)	0.094	22.3 (13.9-n/r)	0.51 (0.31–0.86)	0.011
Mild irAE	24.8 (10.4-n/r)	0.43 (0.28–0.66)	<0.001	35.3 (19.8-n/r)	0.33 (0.21–0.52)	<0.001
24-week Landmark
No irAE	17.2 (9.8–33.5)	ref	ref	16.1 (9.7–37.2)	ref	ref
Severe irAE	14.7 (7.8-n/r)	0.81 (0.44–1.47)	0.481	22.3 (13.9-n/r)	0.62 (0.37–1.05)	0.074
Mild irAE	28.8 (14.3-n/r)	0.51 (0.31–0.84)	0.008	43.9 (19.8-n/r)	0.38 (0.23–0.61)	<0.001