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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STING-activating agents have shown limited efficacy in early-phase clinical trials in cancer patients, either as monotherapy or in combination with immune checkpoint inhibitors.
“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]
The Abstract reports no complete or partial responses with MK-1454 monotherapy, but six partial responses among 25 evaluated patients receiving MK-1454 plus pembrolizumab. Its conclusion calls the combination’s efficacy “encouraging,” contrary to the claim that the combination showed a lack of efficacy. (LLM, conf=0.88)
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Experimental — accuracy not yet measuredClinical trials in cancer patients currently testing STING activating drugs as monotherapy or in combination with immune checkpoint inhibitors have so far provided little, if any, evidence of objective responses.
“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]
The Results (abstract, p. viii712) report no complete or partial responses with MK-1454 monotherapy, but six partial responses among 25 patients (24%) receiving MK-1454 plus pembrolizumab. Those objective responses contradict the claim that the trials provided little, if any, evidence of objective responses, although the monotherapy result is consistent with it. (LLM, conf=0.87)
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Experimental — accuracy not yet measuredPreliminary data showed that some combination therapies (ADU-S100 plus spartalizumab, MK-1454 plus pembrolizumab, manganese plus α-PD-1) had encouraging antitumor activity with a tolerable safety profile.
“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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“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].”
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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].”
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“This has been corrected”
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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).”
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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).”
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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 .”
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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 49 · see citing works
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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 · see citing works
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Responsive manganese-based nanoplatform amplifying cGAS-STING activation for immunotherapy
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“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 · see citing works
“MK-1454 has entered a clinical trial (NCT03010176) to treat advanced solid tumors (Harrington et al., 2018).”
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Phase I dose-escalation and pharmacodynamic study of STING agonist E7766 in advanced solid tumors
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Self-citationIFNγ Signaling in Natural and Therapy-Induced Antitumor Responses
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“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
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“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
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Current status of intralesional agents in treatment of malignant melanoma
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“PRs in head and neck squamous cell carcinoma, triple-negative breast cancer, and anaplastic thyroid carcinoma were observed (41).”
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Beyond DNA sensing: expanding the role of cGAS/STING in immunity and diseases
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Immunomodulatory metal-based biomaterials for cancer immunotherapy
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- 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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