Phase Ib evaluation of a self-adjuvanted protamine formulated mRNA-based active cancer immunotherapy, BI1361849 (CV9202), combined with local radiation treatment in patients with stage IV non-small cell lung cancer

Table 3 Best overall response (safety analysis set)

Parameter	Patients with response, n (%) [95% confidence interval]
Parameter	Stratum 1 (n = 16)	Stratum 2 (n = 8)	Stratum 3 (n = 2)	Overall (n = 26)
Response (CR + PR) rate	1 (6.3) [0.2–30.2]	0 [0.0–36.9]	0 [0.0–84.2]	1 (3.8) [0.1–19.6]
Best overall response
CR	0 [0.0–20.6]	0 [0.0–36.9]	0 [0.0–84.2]	0 [0.0–13.2]
PR	1 (6.3) [0.2–30.2]	0 [0.0–36.9]	0 [0.0–84.2]	1 (3.8) [0.1–19.6]
SD	8 (50.0) [24.7–75.3]	3 (37.5) [8.5–75.5]	1 (50.0) [1.3–98.7]	12 (46.2) [26.6–66.6]
PD	7 (43.8) [19.8–70.1]	4 (50.0) [15.7–84.3]	1 (50.0) [1.3–98.7]	12 (46.2) [26.6–66.6]
NE	0 [0.0–20.6]	1 (12.5) [0.3–52.7]	0 [0.0–84.2]	1 (3.8) [0.1–19.6]

Confirmed response according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1
Abbreviations: CR complete response, NE not evaluable, PD progressive disease, PR partial response, SD stable disease