A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies

Figures & data

Figure 1. Best percentage change from baseline and best overall responses in all patients (naive to prior anti-PD-1/L1 and pretreated) with mesothelioma, NSCLC, melanoma, RCC, and TNBC.

Figure 2. Duration of response per RECIST v1.1 in patients naive to prior anti-PD-1/L1 and pretreated patients.

Table 1. Summary of best overall response, disease control rate, and progression-free survival by RECIST v1.1.

RECIST v1.1	Naive to anti-PD-1/PD-L1, n (%)						Pretreated with anti-PD-1/PD-L1, n (%)
Response by RECIST v1.1	Mesothelioma n = 41	NSCLC n = 20	Melanoma n = 20	RCC n = 19	TNBC Q3W n = 21	TNBC Q4W n = 21	Mesothelioma n = 16	NSCLC n = 22	Melanoma n = 22	RCC n = 19	TNBC n = 14
Best overall response
Complete response (CR)	2 (4.9)	0	0	0	0	0	0	0	1 (4.5)	0	0
Partial response (PR)	5 (12.2)	3 (15.0)	3 (15.0)	5 (26.3)	3 (14.3)	1 (4.8)	1 (6.3)	0	1 (4.5)	1 (5.3)	0
Stable disease (SD)	20 (48.8)	7 (35.0)	6 (30.0)	7 (36.8)	4 (19.0)	4 (19.0)	8 (50.0)	11 (50.0)	7 (31.8)	7 (36.8)	3 (21.4)
Progressive disease (PD)	9 (22.0)	9 (45.0)	6 (30.0)	4 (21.1)	11 (52.4)	12 (57.1)	7 (43.8)	8 (36.4)	12 (54.5)	9 (47.4)	8 (57.1)
ORR (CR+PR), [90% CI]	7 (17.1), [8.3–29.7]	3 (15.0), [4.2–34.4]	3 (15.0), [4.2–34.4]	5 (26.3), [11.0–47.6]	3 (14.3), [4.0–32.9]	1 (4.8), [0.2–20.7]	1 (6.3), [0.3–26.4]	0, [0.0–12.7]	2 (9.1), [1.6–25.9]	1 (5.3), [0.3–22.6]	0, [0.0–19.3]

Abbreviations: CI, confidence interval; DOR, duration of overall response; NSCLC, non-small cell lung cancer; ORR, overall response rate; PD-1, programmed cell death-1; PD-L1, programmed death ligand 1;; RECIST, Response Evaluation Criteria in Solid Tumors; RCC, renal cell cancer; TNBC, triple-negative breast cancer; Q3W, every 3 weeks; Q4W, every 4 weeks.

Figure 3. (a) AEs (=10%) regardless of study drug in patients naive to prior anti-PD-1/L1 and pretreated patients and (b) AEs (=5%) suspected to be study drug related in patients naive to prior anti-PD-1/L1 and pretreated patients.

Figure 4. RNAseq and IHC biomarker assessment: (a) T-cell-inflamed signature at baseline by best overall response, (b) LAG3 gene expression at baseline by best overall response, (c) on-treatment changes in T-cell-inflamed gene signature, and (d) on-treatment changes in LAG3 and CD8 by IHC.