Table 2 Efficacy endpoints in the bTMB ≥16 and ITT populations

From: Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial

Endpoint

bTMB ≥10

bTMB ≥16

 

Atezo

n = 234

Chemo

n = 237

Atezo

n = 145

Chemo

n = 146

Median INV-PFS (95% CI), months

4.1 (2.9, 5.2)

4.4 (4.3, 5.6)

4.5 (3.9, 5.6)

4.3 (4.2, 5.5)

HR (95% CI)

0.91 (0.74, 1.11)

0.77 (0.59, 1.00)

Median IRF-PFS (95% CI), months

2.8 (2.7, 4.2)

5.5 (4.4, 5.9)

3.6 (2.7, 5.2)

4.9 (4.2, 5.7)

HR (95% CI)

1.22 (0.99, 1.50)

1.11 (0.85, 1.45)

Median OS (95% CI), months

10.8 (8.2, 14.0)

10.4 (9.2, 12.2)

13.3 (8.6, 18.4)

10.3 (8.5, 13.8)

HR (95% CI)

0.99 (0.79, 1.25)

0.87 (0.64, 1.17)

Confirmed INV-ORR (95% CI), %

22 (17, 28)

23 (18, 29)

26 (19, 33)

18 (12, 25)

OR (95% CI)

0.94 (0.61, 1.45)

1.57 (0.89, 2.77)

Confirmed IRF-ORR (95% CI), %

23 (18, 29)a

25 (19, 31)a

24 (17, 32)

20 (14, 28)

OR (95% CI)

0.91 (0.59, 1.39)

1.23 (0.70, 2.19)

Median INV-DOR (95% CI), months

14.0 (11.0, 20.8)

n = 52b

5.6 (4.9, 5.7)

n = 55b

11.9 (9.5, 17.0)

n = 37b

5.7 (4.4, 10.6)

n = 26b

HR (95% CI)

0.28 (0.16, 0.50)

0.33 (0.16, 0.68)

Median IRF-DOR (95% CI), months

12.7 (9.5, 17.0)

n = 53a

5.7 (5.5, 7.1)

n = 57a

12.7 (9.1, 14.8)

n = 34a

5.6 (4.2, 11.9)

n = 29a

HR (95% CI)

0.57 (0.34, 0.97)

0.73 (0.36, 1.46)

  1. Atezo, atezolizumab; Chemo, chemotherapy; IRF, independent review facility–assessed; OR, odds ratio.
  2. a Atezo, n = 232; chemo, n = 232.
  3. b n is the number of patients with complete or partial response.
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