Clinical Activity of an hTERT-Specific Cancer Vaccine (Vx-001) in “Immune Desert” NSCLC
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patients and Study Design
2.2. PD-L1 Staining
2.3. Lymphocytic Infiltration
2.4. Immune Response
2.5. Statistical Analysis
3. Results
3.1. TIL Phenotype and PD-L1 Expression
3.2. TILs but Not PD-L1 Predict Vx-001 Efficacy on OS
3.3. TILs but Not PD-L1 Predict Vx-001 Efficacy on TTF
3.4. Functionality of TILs Predicts Activity of Vx-001 on Both OS and TTF
3.5. Vaccine Induced Immune Response and TIL Infiltration
Univariate and Multivariate Analysis
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variable | Total Patients, n = 131 No. of Patients (%) | Vx-001 Arm, n = 63 No. of Patients (%) | Placebo Arm, n = 68 No. of Patients (%) |
---|---|---|---|
Gender | |||
Male | 95 (72.5%) | 44 (69.8%) | 51 (75.0%) |
Female | 36 (27.5%) | 19 (30.2%) | 17 (25.0%) |
Age | |||
<65 years | 63 (48.1%) | 31 (49.2%) | 32 (47.1%) |
≥65 years | 68 (51.9%) | 32 (50.8%) | 36 (52.9%) |
Histology | |||
NSQ/MH | 75 (57.3%) | 34 (54.0%) | 41 (60.3%) |
SQ | 56 (42.7%) | 29 (46.0%) | 27 (39.7%) |
Response to previous treatment | |||
OR | 65 (49.6%) | 27 (49.2%) | 38 (55.9%) |
SD | 66 (50.4%) | 36 (57.1%) | 30 (44.1%) |
Smoking status | |||
Never | 13 (9.9%) | 6 (9.5%) | 7 (10.3%) |
Smokers | 118 (90.1%) | 57 (90.5%) | 61 (89.7%) |
Heavy smokers (>25 years) | 93 (71.0%) | 45 (771.4%) | 48 (70.6%) |
Light smokers (<25 years) | 25 (19.1%) | 12 (19.1%) | 13 (19.1%) |
Univariate Analysis | ||||
---|---|---|---|---|
Covariant Tested vs. Control (HR = 1) | HR a | 95% CI b | p-Value c | Bootstrap p-Value c |
CD3-TILs Low vs. High | 0.395 | 0.194–0.805 | 0.011 | 0.019 |
CD8-TILs Low vs. High | 0.428 | 0.212–0.862 | 0.018 | 0.013 |
GZMB-TILs Low vs. High | 0.310 | 0.122–0.792 | 0.014 | 0.048 |
TAIC Low vs. High | 0.590 | 0.323–1.069 | 0.082 | 0.089 |
Gender Female vs. Male | 1.398 | 0.753–2.595 | 0.288 | 0.285 |
Age ≥65y vs. <65y | 0.963 | 0.543–1.706 | 0.896 | 0.894 |
Response to previous treatment SD vs. OR | 1.349 | 0.748–2.433 | 0.320 | 0.306 |
Histology SQ vs. NSQ/MH | 1.575 | 0.884–2.806 | 0.123 | 0.118 |
Smoking Heavy vs. No/Light | 1.714 | 0.848–3.465 | 0.133 | 0.133 |
Multivariate Analysis d | ||||
CD3-TILs Low vs. High | 0.381 | 0.181–0.799 | 0.011 | 0.015 |
CD8-TILs Low vs. High | 0.388 | 0.182–0.830 | 0.015 | 0.016 |
GZMB-TILs Low vs. High | 0.173 | 0.058–0.520 | 0.002 | 0.003 |
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Pateras, I.S.; Kotsakis, A.; Avgeris, M.; Baliou, E.; Kouroupakis, P.; Patsea, E.; Georgoulias, V.; Menez-Jamet, J.; Kinet, J.-P.; Kosmatopoulos, K. Clinical Activity of an hTERT-Specific Cancer Vaccine (Vx-001) in “Immune Desert” NSCLC. Cancers 2021, 13, 1658. https://doi.org/10.3390/cancers13071658
Pateras IS, Kotsakis A, Avgeris M, Baliou E, Kouroupakis P, Patsea E, Georgoulias V, Menez-Jamet J, Kinet J-P, Kosmatopoulos K. Clinical Activity of an hTERT-Specific Cancer Vaccine (Vx-001) in “Immune Desert” NSCLC. Cancers. 2021; 13(7):1658. https://doi.org/10.3390/cancers13071658
Chicago/Turabian StylePateras, Ioannis S., Athanasios Kotsakis, Margaritis Avgeris, Evangelia Baliou, Panagiotis Kouroupakis, Eleni Patsea, Vassilis Georgoulias, Jeanne Menez-Jamet, Jean-Pierre Kinet, and Kostas Kosmatopoulos. 2021. "Clinical Activity of an hTERT-Specific Cancer Vaccine (Vx-001) in “Immune Desert” NSCLC" Cancers 13, no. 7: 1658. https://doi.org/10.3390/cancers13071658