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Preliminary results of the first-in-human (FIH) study of MK-1454, an agonist of stimulator of interferon genes (STING), as monotherapy or in combination with pembrolizumab (pembro) in patients with advanced solid tumors or lymphomas
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“early-phase clinical trials with these agents in cancer patients, either as monotherapy or in combination with immune checkpoint inhibitors, have so far shown lack of efficacy26–28.”
From Epigenetic state determines the in vivo efficacy of STING agonist therapy (2023) · cites this paper as [26]
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“However, clinical trials in cancer patients currently testing STING activating drugs as a monotherapy or in combination with immune checkpoint inhibitors have so far provided little, if any, evidence of objective responses26–28.”
From Epigenetic state determines the in vivo efficacy of STING agonist therapy (2023) · cites this paper as [26]
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“The preliminary data showed that some combination therapies (e.g. ADU-S100 plus spartalizumab, MK-1454 plus pembrolizumab, manganese plus α-PD-1) had encouraging antitumor activity with a tolerable safety profile [270, 275, 276].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [276]
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DNA sensing by the cGAS–STING pathway in health and disease
Motwani, M., Pesiridis, S., & Fitzgerald, K. A. (2019) · Nature Reviews Genetics · doi:10.1038/s41576-019-0151-1 · Cited by 1,467
Combination strategies with PD-1/PD-L1 blockade: current advances and future directions
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“ADU-S100 plus spartalizumab, MK-1454 plus pembrolizumab, manganese plus α-PD-1) had encouraging antitumor activity with a tolerable safety profile [270, 275, 276].”
BackgroundThe Cytosolic DNA-Sensing cGAS–STING Pathway in Cancer
Kwon, J., & Bakhoum, S. F. (2020) · Cancer Discovery · doi:10.1158/2159-8290.cd-19-0761 · Cited by 1,293
The tumour microenvironment in pancreatic cancer — clinical challenges and opportunities
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Harnessing innate immunity in cancer therapy
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The cGAS–STING pathway and cancer
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Combination strategies to maximize the benefits of cancer immunotherapy
Zhu, S., Zhang, T., Zheng, L., Liu, H., Song, W., Liu, D., Li, Z., & Pan, C.-X. (2021) · Journal of Hematology & Oncology · doi:10.1186/s13045-021-01164-5 · Cited by 654
“Because of the important roles of the cGASSTING pathway in stimulating the anti-cancer immunity, several STING agonists have entered into clinical trials with the combination of ICBs to improve their clinical efficacy [240].”
BackgroundcGAS-STING, an important pathway in cancer immunotherapy
Jiang, M., Chen, P., Wang, L., Li, W., Chen, B., Liu, Y., Wang, H., Zhao, S., Ye, L., He, Y., et al. (2020) · Journal of Hematology & Oncology · doi:10.1186/s13045-020-00916-z · Cited by 647
“The preliminary clinical phase 1 trial of STING agonist (MK-1454) in solid tumors and lymphomas has shown only a modest clinical response using single-agent treatment with no marked activity seen, and the coadministration of it with ICIs in advanced cancers showed only partial responses [80].”
BackgroundImproving cancer immunotherapy through nanotechnology
Goldberg, M. S. (2019) · Nature reviews. Cancer · doi:10.1038/s41568-019-0186-9 · Cited by 628
Roles of natural killer cells in immunity to cancer, and applications to immunotherapy
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Intratumoural administration and tumour tissue targeting of cancer immunotherapies
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Self-citationSTING Agonists as Cancer Therapeutics
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“The preliminary data of a phase I, open-label, multi-arm first-in-human study on MK-1454 was first publicly released at ESMO 2018 [74].”
BackgroundChemical and Biomolecular Strategies for STING Pathway Activation in Cancer Immunotherapy
Garland, K. M., Sheehy, T. L., & Wilson, J. T. (2022) · Chemical Reviews · doi:10.1021/acs.chemrev.1c00750 · Cited by 372
Adaptive immune resistance at the tumour site: mechanisms and therapeutic opportunities
Kim, T. K., Vandsemb, E. N., Herbst, R. S., & Chen, L. (2022) · Nature Reviews Drug Discovery · doi:10.1038/s41573-022-00493-5 · Cited by 361
SLC19A1 is an importer of the immunotransmitter cGAMP.
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Development of Immunotherapy Combination Strategies in Cancer
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“Initial studies of intratumoral STING agonists have also demonstrated the ability of these agents to activate local immune responses and synergize with anti-PD-1 therapy (112,113), although mixed results from trials to date have demonstrated the need for patient selection for these approaches, and further pre-clinical…”
BackgroundProlonged activation of innate immune pathways by a polyvalent STING agonist
Li, S., Luo, M., Wang, Z., Feng, Q., Wilhelm, J., Wang, X., Li, W., Wang, J., Cholka, A., Fu, Y., et al. (2021) · Nature Biomedical Engineering · doi:10.1038/s41551-020-00675-9 · Cited by 327
Trial watch: STING agonists in cancer therapy
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Challenges and Opportunities in the Clinical Development of STING Agonists for Cancer Immunotherapy
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“Merck announced that the combination therapy arm resulted in robust and durable responses which had lasted for at least 6 months, with 24% of patients achieving PR compared to 0% (0/20) in the monotherapy arm and only 20% of patients receiving MK-1454 alone achieved SD [110].”
BackgroundTrial watch: TLR3 agonists in cancer therapy
Le Naour, J., Galluzzi, L., Zitvogel, L., Kroemer, G., & Vacchelli, E. (2020) · OncoImmunology · doi:10.1080/2162402x.2020.1771143 · Cited by 239
ZnS@BSA Nanoclusters Potentiate Efficacy of Cancer Immunotherapy
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Hydrogel drug delivery systems for minimally invasive local immunotherapy of cancer
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The interactions between cGAS-STING pathway and pathogens
Cheng, Z., Dai, T., He, X., Zhang, Z., Xie, F., Wang, S., Zhang, L., & Zhou, F. (2020) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-020-0198-7 · Cited by 216
“Two phase I clinical trials with STING agonists (ADUS100 and MK1454) have received good feedback, showing that dose escalation was tolerated and that CD8 T-cell infiltration in tumours was evident.(161,162) However, both STING agonists showed maximum efficacy only when delivered intratumourally, which might limit thei…”
BackgroundHuman Anti-tumor Immunity: Insights from Immunotherapy Clinical Trials
Egen, J. G., Ouyang, W., & Wu, L. C. (2020) · Immunity · doi:10.1016/j.immuni.2019.12.010 · Cited by 198
The cGAS/STING Pathway: A Novel Target for Cancer Therapy
Gan, Y., Li, X., Han, S., Liang, Q., Ma, X., Rong, P., Wang, W., & Li, W. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2021.795401 · Cited by 194
“PRs observed in head and neck squamous cell carcinoma, triple-negative breast cancer and undifferentiated thyroid cancer (87).”
BackgroundDendritic cell maturation in cancer
Moon, C. Y., Belabed, M., Park, M. D., Mattiuz, R., Puleston, D. J., & Mérad, M. (2025) · Nature reviews. Cancer · doi:10.1038/s41568-024-00787-3 · Cited by 189
“Despite such challenges, STING agonists have shown initially encouraging results in combination with immunotherapy in clinical trials 362,363 .”
The cGAS‒STING pathway in cancer immunity: mechanisms, challenges, and therapeutic implications
Shen, M., Jiang, X., Qiu, P., Oyang, L., Ren, Z., Wang, J., Peng, M., Zhou, Y., Deng, X., & Liao, Q. (2025) · Journal of Hematology & Oncology · doi:10.1186/s13045-025-01691-5 · Cited by 210
“Preliminary data suggest that although MK-1454 has limited efficacy as a mono-therapy, its combination with pembrolizumab has shown encouraging results, including tumor regression in both injectable and noninjectable lesions [104].”
ExoSTING, an extracellular vesicle loaded with STING agonists, promotes tumor immune surveillance
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“However, drug delivery challenges, including rapid clearance from the TME, poor cell internalization and systemic toxicity, have limited CDN efficacy in preclinical and clinical trials 17,18 .”
BackgroundThe 6th R of Radiobiology: Reactivation of Anti-Tumor Immune Response
Boustani, J., Grapin, M., Laurent, P.-A., Apétoh, L., & Mirjolet, C. (2019) · Cancers · doi:10.3390/cancers11060860 · Cited by 178
Clinical landscape of macrophage-reprogramming cancer immunotherapies
Rannikko, J. H., & Hollmén, M. (2024) · British Journal of Cancer · doi:10.1038/s41416-024-02715-6 · Cited by 169
STING suppresses bone cancer pain via immune and neuronal modulation
Wang, K., Donnelly, C. R., Jiang, C., Liao, Y., Luo, X., Tao, X., Bang, S., McGinnis, A., Lee, M. S., Hilton, M. J., et al. (2021) · Nature Communications · doi:10.1038/s41467-021-24867-2 · Cited by 140
Targeting Stimulator of Interferon Genes (STING): A Medicinal Chemistry Perspective
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Dendritic Cells, the T-cell-inflamed Tumor Microenvironment, and Immunotherapy Treatment Response
Garris, C., & Luke, J. J. (2020) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-19-1321 · Cited by 146
“Clinical data have been disclosed for ADU-S100 and MK-1454 (79), demonstrating the induction of systemic type I IFN response, however little intratumoral biomarker data have been released.”
The Development of STING Agonists and Emerging Results as a Cancer Immunotherapy
Hines, J. B., Kacew, A. J., & Sweis, R. F. (2023) · Current Oncology Reports · doi:10.1007/s11912-023-01361-0 · Cited by 133
Targeting Innate Immunity in Cancer Therapy
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“MK1454 is undergoing clinical evaluation as monotherapy or in combination with pembrolizumab for the treatment of advanced solid tumors [NCT03010176, NCT04220866] [116].”
BackgroundOvercoming cold tumors: a combination strategy of immune checkpoint inhibitors
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Type I IFN activating type I dendritic cells for antitumor immunity
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Myeloid Cells as Clinical Biomarkers for Immune Checkpoint Blockade
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“The combination of intratumoral MK-1454 plus Pembrolizumab resulted in encouraging efficacy and an acceptable safety profile in solid tumors or lymphomas (163).”
BackgroundImmunotherapy in non-small cell lung cancer: Past, present, and future directions
Punekar, S. R., Shum, E., Grello, C., Lau, S. C. M., & Velcheti, V. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.877594 · Cited by 89
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cGAS-STING pathway as a potential trigger of immunosenescence and inflammaging
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“In 2018, preliminary clinical study data were released, which also demonstrated a better efficacy profile in patients treated with MK-1454 in combination with pembrolizumab compared with MK-1454 monotherapy [23].”
BackgroundResultLifting the innate immune barriers to antitumor immunity
Rothlin, C. V., & Ghosh, S. (2020) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2020-000695 · Cited by 83
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cGAS–STING, an important signaling pathway in diseases and their therapy
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Agonists and Inhibitors of the cGAS-STING Pathway
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“Similarly, MK-1454 showed no overall response for monotherapy when administered intratumorally, and a 24% overall response when combined with the anti-PD-1 monoclonal antibody pembrolizumab [144].”
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The Evolution of STING Signaling and Its Involvement in Cancer
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Overcoming resistance to STING agonist therapy to incite durable protective antitumor immunity
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Activation of Stimulation of Interferon Genes (STING) Signal and Cancer Immunotherapy
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“The prior phase I study (NCT03010176) on MK-1454 demonstrated good activity and safety in patients with advanced solid tumors or lymphomas when injected with MK-1454 alone or in combination with ICI pembrolizumab [61].”
BackgroundLipid‐based nanoparticles as drug delivery systems for cancer immunotherapy
Hao, Y., Ji, Z., Zhou, H., Wu, D., Gu, Z., Wang, D., & ten Dijke, P. (2023) · MedComm · doi:10.1002/mco2.339 · Cited by 71
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“This has been corrected”
Promising targets based on pattern recognition receptors for cancer immunotherapy
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Self-citationPathogen Molecular Pattern Receptor Agonists: Treating Cancer by Mimicking Infection
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“MK-1454 (Merck), a similar cyclic dinucleotide agonist currently in a phase I trial in combination with PD-1 blockade (NCT03010176) has shown favorable safety profiles and an objective response rate of 20% across several cancer types, with a median depth of response of approximately 80% (90).”
BackgroundSelf-citationSTING Agonists and How to Reach Their Full Potential in Cancer Immunotherapy
Gehrcken, L., Deben, C., Smits, E., & Audenaerde, J. R. M. V. (2025) · Advanced Science · doi:10.1002/advs.202500296 · Cited by 66
Evading the STING: LKB1 Loss Leads to STING Silencing and Immune Escape in KRAS-Mutant Lung Cancers
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“Preliminary data from the phase I trial of MK-1454 with pembrolizumab (NCT03010176) showed a safe tolerability profile and encouraging efficacy, with serum levels of STING-dependent cytokines increased posttreatment, confirming STING activation (8).”
MethodStrategies targeting tumor immune and stromal microenvironment and their clinical relevance
Hu, M., & Huang, L. (2022) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2022.114137 · Cited by 60
Opportunities and challenges of targeting cGAS–STING in cancer
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“MK-1454, administered weekly via intratu-moural injection, showed no antitumour activity as a monotherapy and only limited clinical responses in the combination 127 .”
Putting the STING back into BH3-mimetic drugs for TP53-mutant blood cancers
Diepstraten, S. T., Yuan, Y., Marca, J. E. L., Young, S., Chang, C. W. T., Whelan, L., Ross, A. M., Fischer, K. C., Pomilio, G., Morris, R., et al. (2024) · Cancer Cell · doi:10.1016/j.ccell.2024.04.004 · Cited by 56
Targeting Myeloid Cells in Combination Treatments for Glioma and Other Tumors
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Current strategies for intratumoural immunotherapy – Beyond immune checkpoint inhibition
Yuan, J. D., Khilnani, A. D., Brody, J., Andtbacka, R. H. I., Hu‐Lieskovan, S., Luke, J. J., Diab, A. K., Marabelle, A., Snyder, A., Cao, Z. A., et al. (2021) · European Journal of Cancer · doi:10.1016/j.ejca.2021.08.004 · Cited by 50
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“Notably, ongoing clinical trials investigating the effect of the STING agonists ADU-S100 and MK-1454 in combination with PD-1/PD-L1 blockade show preliminary but encouraging outcomes in patients with solid tumors and lymphomas (95, 96).”
BackgroundSadagopan, A., Michelakos, T. P., Boyiadzis, G., Ferrone, C. R., & Ferrone, S. (2021) · JAMA Oncology · doi:10.1001/jamaoncol.2021.5970 · Cited by 49
Targeting STING in cancer: Challenges and emerging opportunities
Zhao, K., Huang, J., Zhao, Y., Wang, S., Xu, J., & Yin, K. (2023) · Biochimica et Biophysica Acta (BBA) - Reviews on Cancer · doi:10.1016/j.bbcan.2023.188983 · Cited by 57
Responsive manganese-based nanoplatform amplifying cGAS-STING activation for immunotherapy
He, Q., Zheng, R., Ma, J., Zhao, L., Shi, Y., & Qiu, J. (2023) · Biomaterials Research · doi:10.1186/s40824-023-00374-x · Cited by 49
“Nevertheless, single drugs that rely solely on STING agonists, such as cyclic dinucleotide (CDN), are not significantly effective in two phase I clinical trials against solid tumors or lymphomas [17], which could attribute to rapid clearance and poor internalization of STING agonists [18] and immunosuppression of exce…”
BackgroundTherapeutic Development by Targeting the cGAS-STING Pathway in Autoimmune Disease and Cancer
Li, Q., Tian, S., Liang, J., Fan, J., Lai, J., & Chen, Q. (2021) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.779425 · Cited by 47
“MK-1454 has entered a clinical trial (NCT03010176) to treat advanced solid tumors (Harrington et al., 2018).”
BackgroundQu, C. F., Shao, X., Jia, R., Song, G., Shi, D., Wang, H., Wang, J., & An, H. (2024) · ACS Nano · doi:10.1021/acsnano.4c05483 · Cited by 49
Phase I dose-escalation and pharmacodynamic study of STING agonist E7766 in advanced solid tumors
Luke, J. J., Pinato, D. J., Juric, D., LoRusso, P. M., Hosein, P. J., Desai, A. M., Haddad, R. I., de Miguel, M., Cervantes, A. M. R., Kim, W. S., et al. (2025) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2024-010511 · Cited by 51
Self-citationIFNγ Signaling in Natural and Therapy-Induced Antitumor Responses
Martínez, A., Arenas, E. J., & Arribas, J. (2021) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-21-3226 · Cited by 47
Xu, H., Wedn, A. M., Wang, J., Gu, Y., Liu, H., Zhang, J., Lin, Z., Zhou, R., Pang, X., & Cui, Y. (2024) · Pharmacological Research · doi:10.1016/j.phrs.2024.107063 · Cited by 49
Wolf, N. K., Blaj, C., Picton, L. K., Snyder, G., Zhang, L., Nicolai, C. J., Ndubaku, C. O., McWhirter, S. M., García, K. C., & Raulet, D. H. (2022) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.2200568119 · Cited by 46
“At the same time, early-phase clinical trials of STING agonists in patients have not yielded sustained clinical remissions (33, 34), indicating a need for improvements in this immunotherapy approach.”
BackgroundPP2Ac/STRN4 negatively regulates STING-type I IFN signaling in tumor-associated macrophages
Ho, W. S., Mondal, I., Xu, B., Das, O., Sun, R., Chiou, P., Cai, X., Tahmasebinia, F., McFadden, E., Wu, C. Y.-J., et al. (2023) · Journal of Clinical Investigation · doi:10.1172/jci162139 · Cited by 45
“Despite promising preclinical studies, several small-molecule agonists of STING have shown limited clinical efficacy in early phase clinical trials (9).”
SHR1032, a novel STING agonist, stimulates anti-tumor immunity and directly induces AML apoptosis
Song, C., Liu, D., Liu, S., Li, D., Horecny, I., Zhang, X., Li, P., Chen, L., Miller, M., Chowdhury, R., et al. (2022) · Scientific Reports · doi:10.1038/s41598-022-12449-1 · Cited by 43
Álvarez, M., Molina, C., de Andrea, C. E., Fernández-Sendin, M., Villalba-Esparza, M., González-Gomariz, J., Ochoa, M. C., Teijeira, Á., Glez‐Vaz, J., Aranda, F., et al. (2021) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2021-002953 · Cited by 44
Huang, Y., Nahar, S., Alam, M. M., Hu, S., McVicar, D. W., & Yang, D. (2023) · ACS Nano · doi:10.1021/acsnano.3c03195 · Cited by 43
Current status of intralesional agents in treatment of malignant melanoma
Zawit, M., Swami, U., Awada, H. K., Arnouk, J., Milhem, M. M., & Zakharia, Y. (2021) · Annals of Translational Medicine · doi:10.21037/atm-21-491 · Cited by 44
“PRs in head and neck squamous cell carcinoma, triple-negative breast cancer, and anaplastic thyroid carcinoma were observed (41).”
BackgroundXian, S., Chen, X., Ren, S., Chen, X., & Wang, H. (2024) · Cancer Research · doi:10.1158/0008-5472.can-23-3511 · Cited by 41
Zhang, W., & Huang, X. (2025) · Biomarker Research · doi:10.1186/s40364-025-00750-w · Cited by 44
Beyond DNA sensing: expanding the role of cGAS/STING in immunity and diseases
Seok, J. K., Kim, M., Kang, H. C., Cho, Y., Lee, H. S., & Lee, J. Y. (2023) · Archives of Pharmacal Research · doi:10.1007/s12272-023-01452-3 · Cited by 45
Immunomodulatory metal-based biomaterials for cancer immunotherapy
Yuan, K., Zhang, C., Pan, X., Hu, B., Zhang, J., & Yang, G. (2024) · Journal of Controlled Release · doi:10.1016/j.jconrel.2024.09.008 · Cited by 40
Advances in polymer nanomaterials targeting cGAS-STING pathway for enhanced cancer immunotherapy
Peng, S., Hou, X., Liu, J., & Huang, F. (2025) · Journal of Controlled Release · doi:10.1016/j.jconrel.2025.02.056 · Cited by 39
Innate sensors that regulate vaccine responses
Georg, P., & Sander, L. E. (2019) · Current Opinion in Immunology · doi:10.1016/j.coi.2019.02.006 · Cited by 36
Metadata
- Authors
- Harrington, K. J., Brody, J., Ingham, M., Strauss, J., Cemerski, S., Wang, M., Tse, A., Khilnani, A., Marabelle, A., & Golan, T.
- Affiliations
- Institute of Cancer Research (GB)
- Mount Sinai Hospital (US)
- Columbia University Irving Medical Center (US)
- Mary Crowley Cancer Research Center (US)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Institut Gustave Roussy (FR)
- Sheba Medical Center (IL)
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2018-10
- Volume
- 29
- Pages
- viii712
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2898106814
- Cited by
- 280
- References
- 0
- Citations by year
- 2026: 34 · 2025: 50 · 2024: 37 · 2023: 28 · 2022: 42 · 2021: 50 · 2020: 18 · 2019: 20
- FWCI
- 9.57
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- Funders
- Amgen
- Pfizer
- AstraZeneca
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › interferon and immune responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Keywords
- STING agonist, cyclic dinucleotides, pembrolizumab, immune checkpoint inhibitor combination, advanced solid tumors, lymphoma, antitumor immunity, intratumoral administration
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