WT1-mRNA dendritic cell vaccination of patients with glioblastoma multiforme, malignant pleural mesothelioma, metastatic breast cancer, and other solid tumors: type 1 T-lymphocyte responses are associated with clinical outcome

Table 1 Clinical responses and overall survival by patient group

	GBM	MBC	MPM	Other*
Clinical response at T1
CR (%)	0/13 (0%)	0/12 (0%)	0/10 (0%)	0/4 (0%)
PR (%)	1/13 (7.7%)	0/12 (0%)	0/10 (0%)	1/4 (25%)
SD (%)	8/13 (61.5%)	6/12 (50%)	7/10 (70%)	2/4 (25%)
PD (%)	4/13 (30.8%)	6/12 (50%)	3/10 (30%)	1/4 (25%)
ORR	1/13 (7.7%)	0/12 (0%)	0/10 (0%)	1/4 (25%)
DCR	9/13 (69.2%)	6/12 (50%)	7/10 (70%)	3/4 (75%)
Clinical response at T2
CR (%)	0/13 (0%)	0/12 (0%)	0/10 (0%)	1/4 (25%)
PR (%)	3/13 (23.1%)	0/12 (0%)	0/10 (0%)	1/4 (25%)
SD (%)	3/13 (23.1%)	6/12 (50%)	4/10 (40%)	1/4 (25%)
PD (%)	7/13 (53.8%)	6/12 (50%)	5/10 (50%)	1/4 (25%)
Death (%)	0/13 (0%)	0/12 (0%)	1/10 (10%)	0/4 (0%)
ORR	3/13 (23.1%)	0/12 (0%)	0/10 (0%)	2/4 (50%)
DCR	6/13 (46.2%)	6/12 (50%)	4/10 (40%)	3/4 (75%)
Clinical response at T1 ± T2
ORR	3/13 (23.1%)	0/12 (0%)	0/10 (0%)	2/4 (50%)
DCR	9/13 (69.2%)	9/12 (75%)	7/10 (70%)	4/4 (100%)
DCR without cancer Tx at T1 ± T2	1/13 (7.7%)	3/12 (25%)	7/10 (70%)	3/4 (75%)
DCR without other Tx at T1 ± T2	1/13 (7.7%)	2/12 (16.7%)	7/10 (70%)	2/4 (50%)
Overall survival^#
N patients alive (%)	0/13 (0%)	0/12 (0%)	0/10 (0%)	2/4 (50%)
Median OS from V1 (range), mo	23.5 (5.0–56.4)	26.7 (8.4–58.3)	28.2 (5.6–63.0)
Median OS from Dx (range), mo	43.7 (13.8–70.4)	41.9 (14.5–117.7)	48.8 (21.8–134.8)
Frequency of OS > Reference	12/13	7/12	9/10
HR⁻/HER2⁻ MBC		3/4
HR⁺/HER2⁻ MBC		2/5
HER2⁺ MBC		2/3

# = observed survival calculated from V1 or from diagnosis until death or up to December 31, 2023
Abbreviations: GBM = glioblastoma multiforme. MBC = metastatic breast cancer. MPM = malignant pleural mesothelioma. Other = mixed cohort of other tumor types. T1 = 8 weeks after the start of vaccination. T2 = 6 months after the start of vaccination. CR = complete remission. PR = partial response. SD = stable disease. PD = progressive disease. ORR = overall response rate (CR, PR). DCR = disease control rate (CR, PR, SD). T1 ± T2 = T1 and/or T2. Tx = treatment (cancer Tx = chemotherapy, radiotherapy, and/or tumor surgery; other Tx = chemotherapy, radiotherapy, (tumor) surgery, antihormonal treatment, and/or monoclonal antibodies). N = number of. OS = overall survival. V1 = first WT1-mRNA/DC vaccination. mo = months. Dx = diagnosis (for MBC = diagnosis of metastatic disease). OS > Reference = OS higher than expected median OS based on historical controls reported in the literature [3,4,5].
*SOL02 died prematurely (before WT1-mRNA/DC vaccination) and was excluded from the analysis

ISSN: 1756-8722