Table 2 Summary of tumor response per RECIST 1.1 by independent review committee in the intention-to-treat patient population

From: Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial

Response

Cemiplimab + chemotherapy (n = 312)

Placebo + chemotherapy (n = 154)

Objective response

 Patients, n

135

35

 % (95% CI)

43.3 (37.7–49.0)

22.7 (16.4–30.2)

 Odds ratio (95% CI)

2.68 (1.72–4.19); P < 0.0001

Best overall response, n (%)

 Complete response

8 (2.6)

0

 Partial response

127 (40.7)

35 (22.7)

 Stable disease

121 (38.8)

74 (48.1)

 Progressive disease

22 (7.1)

24 (15.6)

 NE

30 (9.6)

20 (13.0)

Kaplan–Meier estimated DOR, median (95% CI), months

15.6 (12.4–NE)

7.3 (4.3–12.6)

Observed time to response, median (IQR), months

2.1 (2.0–2.3)

2.1 (2.1–3.9)

  1. Objective response and the corresponding two-sided 95% CI were calculated using the Clopper–Pearson method. The odds ratio and corresponding two-sided 95% CI of the objective response were calculated by the Cochran–Mantel–Haenszel method. The median DOR and corresponding two-sided 95% CI were estimated by the Kaplan–Meier method. Observed time to response and the corresponding IQR were summarized descriptively.
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