A phase II trial of mTORC1/2 inhibition in STK11 deficient non small cell lung cancer
Open accessAbstract
There are no current stratified medicine options for STK11-deficient NSCLC. STK11 loss mediates mTORC activation, GLUT1 up-regulation and increased glycolysis. This metabolic reprogramming might represent a therapeutic vulnerability targetable with mTORC1/2 inhibition. In arm B2 of the National Lung Matrix Trial 54 patients with NSCLC received vistusertib, of which 49 were STK11-deficient (30 with KRAS mutation (B2D), 19 without (B2S)). Objective response (OR) and durable clinical benefit (DCB) rates with 95% credible intervals (CrI) were estimated from posterior probability distributions generated using Bayesian beta-binomial conjugate analysis. In B2D, 2 per-protocol patients obtained OR (estimated true OR rate (95%CrI) 9.8% (2.4–24.3). Estimates of true DCB rate (95%CrI): B2D 24.4% (11.1–42.3), B2S 14.6% (3.6–34.7). Overall, vistusertib cannot be recommended in this context. Longitudinal ctDNA analysis demonstrates enrichment of SMARCA4 mutations post-treatment. In vitro studies show adaptive resistance to mTORC1/2 inhibition via AKT reactivation. (NCT02664935, ISRCTN38344105, EudraCT 2014-000814-73, 10 June 2015)
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We did not identify targets related to pathways previously investigated for STK11-mutant cancer therapy, such as glutamine synthesis or mTOR signaling.
“we did not identify targets related to pathways previously investigated for STK11-mutant cancer therapy, such as glutamine synthesis (37) or mTOR signaling (38, 39).”
From TNG260 Is a Small-Molecule CoREST Inhibitor That Sensitizes <i>STK11</i> -Mutant Tumors to Anti–PD-1 Immunotherapy (2025) · cites this paper as [39]
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- Authors
- Middleton, G., Robbins, H. L., Fletcher, P., Savage, J., Mehmi, M., Summers, Y., Greystoke, A., Steele, N., Popat, S., Jain, P., Spicer, J., Cave, J., Shaw, P., Gilligan, D., Power, D., Fennell, D., Bajracharya, M., McBride, D. J., Maheswari, U., Frankell, A. M., Swanton, C., Beggs, A. D., & Billingham, L.
- Affiliations
- University Hospitals Birmingham NHS Foundation Trust (GB)
- Cancer Research UK Clinical Trials Unit (GB)
- The Christie Hospital (GB)
- Newcastle University (GB)
- Beatson West of Scotland Cancer Centre (GB)
- Royal Marsden Hospital (GB)
- St James's University Hospital (GB)
- Guy's Hospital (GB)
- University Hospital Southampton NHS Foundation Trust (GB)
- Velindre Cancer Centre (GB)
- Addenbrooke's Hospital (GB)
- Imperial College Healthcare NHS Trust (GB)
- Leicester Royal Infirmary (GB)
- Illumina (United Kingdom) (GB)
- The Francis Crick Institute (GB)
- Corresponding author
- Middleton, Gary
- ORCID
- Middleton, Gary
- Robbins, Helen L.
- Fletcher, Peter
- Savage, Joshua
- Mehmi, Manita
- Summers, Yvonne
- Greystoke, Alastair
- Steele, Nicola
- Popat, Sanjay
- Jain, Pooja
- Spicer, James
- Cave, Judith
- Gilligan, David
- Fennell, Dean
- McBride, David J.
- Maheswari, Uma
- Frankell, Alexander M.
- Swanton, Charles
- Beggs, Andrew D.
- Billingham, Lucinda
- Venue
- npj Precision Oncology
- Published
- 2025-03-11
- Volume
- 9
- Issue
- 1
- Pages
- 67-67
- ISSN
- 2397-768X (ISSN-L)
- PMC
- PMC11897347
- OpenAlex
- W4408337283
- Cited by
- 7
- References
- 63
- Citations by year
- 2026: 4 · 2025: 3
- FWCI
- 4.60
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
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- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- The Francis Crick Institute (cc-by)
- Funders
- AstraZeneca
- Cancer Research UK (A22209, C22436/A25354, C11497/A19363, A19363)
- National Institute for Health and Care Research
- Imperial Experimental Cancer Medicine Centre
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › PI3K/AKT/mTOR signaling in cancer
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Chromatin Remodeling and Cancer
- Keywords
- non-small cell lung cancer, mTORC1/2 inhibition, vistusertib, KRAS mutation, metabolic reprogramming, glycolysis, SMARCA4 mutation, adaptive resistance, ctDNA, objective response rate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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