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Articles & Key Literature

Recent peer-reviewed evidence behind patient-derived organoid drug screening: clinical studies from the last few years showing organoids predicting patient response across solid tumor types, current expert reviews, and the regulatory shift toward human-relevant models.

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Clinical Evidence

Organoid Drug Screening Predicts Patient Response Across Solid Tumors

Recent clinical studies, all published since 2022, comparing patient-derived organoid drug responses with the treatment outcomes of the same patients. Indication by indication, the same picture: what the organoid does in the assay tracks what the tumor does in the clinic.

Colorectal cancer

Patient-derived organoids predict treatment response in metastatic colorectal cancer

Smabers LP, Wensink GE, Verissimo CS, et al. · Clinical Cancer Research, 2025; 31(23): 5015–5026

A prospective clinical study in metastatic colorectal cancer showing that ex vivo drug screening on patient-derived organoids predicted the treatment response of the patients they came from: current, trial-grade evidence for organoid-guided response prediction in the most screened indication.

Read the paper →DOI: 10.1158/1078-0432.CCR-25-1564

Ovarian cancer

In vitro drug testing using patient-derived ovarian cancer organoids

Chen LY, Chou YT, Liew PL, et al. · Journal of Ovarian Research, 2024; 17: 194

Organoids generated from surgically resected ovarian cancers and screened against chemotherapy agents, with in vitro sensitivities correlating well with the clinical responses of the corresponding patients: a route toward personalised chemotherapy selection in a disease where second-line response rates are low.

Read the paper →DOI: 10.1186/s13048-024-01520-2

Gastric cancer

Personalized drug screening using patient-derived organoid and its clinical relevance in gastric cancer

Zhao Y, et al. · Cell Reports Medicine, 2024; 5(7): 101627

Organoids established from 78% of a 73-patient gastric cancer cohort, with drug-response profiling validated in organoid-derived xenografts and matching the actual clinical response in 11 of 12 patients (92%), alongside expression biomarkers separating 5-FU- and oxaliplatin-sensitive from resistant tumors.

Read the paper →DOI: 10.1016/j.xcrm.2024.101627

Head & neck cancer

Patient-derived head and neck cancer organoids allow treatment stratification and serve as a tool for biomarker validation and identification

Millen R, et al. · Med (Cell Press), 2023; 4(5): 290–310

Head and neck squamous cell carcinoma organoids whose ex vivo radiotherapy response correlated with relapse-free survival in patients treated with adjuvant radiotherapy, and which supported drug testing of radiosensitizers: functional stratification where treatment decisions are hardest.

Read the paper →DOI: 10.1016/j.medj.2023.04.003

Lung cancer

Using patient-derived organoids to predict locally advanced or metastatic lung cancer tumor response: a real-world study

Wang H-M, et al. · Cell Reports Medicine, 2023; 4(1): 100911

Fifty-four organoid lines from 36 lung cancer patients, tested against osimertinib, chemotherapy, and combination regimens in a real-world setting: organoid drug sensitivity predicted clinical response with 84% sensitivity, 83% specificity, and 83% overall accuracy.

Read the paper →DOI: 10.1016/j.xcrm.2022.100911

Pancreatic cancer

Pancreatic cancer patient-derived organoids can predict response to neoadjuvant chemotherapy

Demyan L, Habowski AN, et al. · Annals of Surgery, 2022; 276(3): 450–462

In a prospective 2017–2021 cohort, organoids were established from resected pancreatic adenocarcinoma at high success rates and screened within days of surgery; organoid chemotherapy responses correlated with the pathological response to neoadjuvant treatment, most clearly for oxaliplatin.

Read the paper →DOI: 10.1097/SLA.0000000000005558

Reviews & Perspectives

Where the Field Stands Today

Current expert syntheses of functional precision oncology and patient-derived organoid drug screening, for readers who want the full scientific context in one sitting.

Review

Functional precision oncology using patient-derived assays: bridging genotype and phenotype

van Renterghem AWJ, van de Haar J, Voest EE. · Nature Reviews Clinical Oncology, 2023; 20(5): 305–317

The current reference review of functional precision oncology: why genomics alone leaves most patients unmatched, and how patient-derived models, organoids foremost, close the genotype-to-phenotype gap by testing therapies directly on living tumor tissue.

Read the paper →DOI: 10.1038/s41571-023-00745-2

Regulatory Landscape

Regulators Are Moving the Same Way

Drug development no longer has to run through animal models by default. Since 2022 the regulatory ground has shifted decisively toward human-relevant new approach methodologies, and organoids are named among them.

FDA policy

Roadmap to reducing animal testing in preclinical safety studies

U.S. Food and Drug Administration, announced 10 April 2025 · FDA press announcement and policy roadmap

The FDA’s plan to phase out animal-testing requirements for monoclonal antibodies and other drugs in favor of human-relevant new approach methodologies, naming lab-grown human organoids and organ-on-a-chip systems among the replacement technologies.

Read the paper →

US legislation

FDA Modernization Act 2.0

United States Congress, S.5002, signed into law 29 December 2022 · Public Law 117-328

Removes the statutory requirement that new drugs be tested in animals before human trials, explicitly allowing alternatives including cell-based assays, organoids, organs-on-chips, and computational models to support investigational applications.

Read the paper →

Foundational Literature

The Studies That Built the Field

The recent clinical evidence above stands on a decade of landmark work: the first tumor organoid biobanks, the first prospective response-prediction trials, and the perspectives that defined functional precision oncology.

Systematic review

Patient-derived organoids as a predictive biomarker for treatment response in cancer patients

Wensink GE, Elias SG, Mullenders J, et al. · npj Precision Oncology, 2021; 5: 30

A systematic review pooling the published evidence on organoid-based response prediction across tumor types, assessing analytical validity, clinical validity, and clinical utility. Useful as a single entry point into the predictive-biomarker literature this field is built on.

Read the paper →DOI: 10.1038/s41698-021-00168-1

Rectal cancer

Patient-derived organoids predict chemoradiation responses of locally advanced rectal cancer

Yao Y, Xu X, Yang L, et al. · Cell Stem Cell, 2020; 26(1): 17–26

A living organoid biobank built alongside a phase III trial in locally advanced rectal cancer. Organoid responses matched patient chemoradiation outcomes with 84% accuracy (78% sensitivity, 92% specificity), supporting organoid testing as a companion tool for treatment stratification.

Read the paper →DOI: 10.1016/j.stem.2019.10.010

Colorectal cancer

Patient-derived organoids can predict response to chemotherapy in metastatic colorectal cancer patients

Ooft SN, Weeber F, Dijkstra KK, et al. · Science Translational Medicine, 2019; 11(513): eaay2574

A prospective study showing that organoids generated from metastatic colorectal cancer biopsies predicted response to irinotecan-based chemotherapy in more than 80% of patients, without misclassifying any patient who would have benefited. A template for using organoids to spare non-responders ineffective treatment.

Read the paper →DOI: 10.1126/scitranslmed.aay2574

Rectal cancer

A rectal cancer organoid platform to study individual responses to chemoradiation

Ganesh K, Wu C, O’Rourke KP, et al. · Nature Medicine, 2019; 25(10): 1607–1614

Rectal cancer organoids retained the histopathology and genomic alterations of their matched tumors, and their ex vivo responses to chemotherapy and radiation paralleled patients’ progression-free survival: independent confirmation that organoid drug testing tracks clinical outcome.

Read the paper →DOI: 10.1038/s41591-019-0584-2

Lung cancer

Patient-derived lung cancer organoids as in vitro cancer models for therapeutic screening

Kim M, Mun H, Sung CO, et al. · Nature Communications, 2019; 10: 3991

Lung cancer organoids spanning five histological subtypes that preserved the architecture and genomic alterations of the primary tumors through long-term expansion, and responded to targeted drugs in line with the underlying genotype: subtype-aware screening for the world’s deadliest cancer.

Read the paper →DOI: 10.1038/s41467-019-11867-6

Perspective

Cancer modeling meets human organoid technology

Tuveson D, Clevers H. · Science, 2019; 364(6444): 952–955

A field-defining perspective from two pioneers of the technology on how self-organizing 3D cultures recapitulate the structure and function of the tissues they model, and what that means for cancer research and drug development.

Read the paper →DOI: 10.1126/science.aaw6985

Prospective trial

Patient-derived organoids model treatment response of metastatic gastrointestinal cancers

Vlachogiannis G, Hedayat S, Vatsiou A, et al. · Science, 2018; 359(6378): 920–926

Organoids from 110 metastatic biopsies of patients in phase I/II trials mirrored the mutation spectrum and phenotype of the original tumors. Drug responses in the dish forecast responses in the clinic with 100% sensitivity, 93% specificity, 88% positive and 100% negative predictive value: the landmark demonstration that ex vivo organoid testing carries real clinical signal.

Read the paper →DOI: 10.1126/science.aao2774

Pancreatic cancer

Organoid profiling identifies common responders to chemotherapy in pancreatic cancer

Tiriac H, Belleau P, Engle DD, et al. · Cancer Discovery, 2018; 8(9): 1112–1129

A pancreatic cancer organoid library recapitulating the mutational spectrum and transcriptional subtypes of the primary disease, paired with a drug-testing pipeline (“pharmacotyping”) shown to parallel patient responses to chemotherapy: functional testing in one of the hardest-to-treat solid tumors.

Read the paper →DOI: 10.1158/2159-8290.CD-18-0349

Gastric cancer

A comprehensive human gastric cancer organoid biobank captures tumor subtype heterogeneity and enables therapeutic screening

Yan HHN, Siu HC, Law S, et al. · Cell Stem Cell, 2018; 23(6): 882–897

A 63-line biobank from 34 patients spanning normal, dysplastic, primary, and metastatic gastric tissue with whole-exome and transcriptome characterization, in which large-scale drug screening surfaced sensitivities to agents in clinical development.

Read the paper →DOI: 10.1016/j.stem.2018.09.016

Breast cancer

A living biobank of breast cancer organoids captures disease heterogeneity

Sachs N, de Ligt J, Kopper O, et al. · Cell, 2018; 172(1–2): 373–386

More than 100 primary and metastatic breast cancer organoid lines reproducing the genetic and pathological diversity of the disease, with organoid drug responses matching tumor subtype biology. Demonstrates that organoid panels can represent patient heterogeneity at scale.

Read the paper →DOI: 10.1016/j.cell.2017.11.010

Prostate cancer

A PDX/organoid biobank of advanced prostate cancers captures genomic and phenotypic heterogeneity for disease modeling and therapeutic screening

Beshiri ML, Tice CM, Tran C, et al. · Clinical Cancer Research, 2018; 24(17): 4332–4345

Organoids derived from advanced, castration-resistant prostate cancers, built explicitly as a therapeutic-screening resource: the models retained the genomic and phenotypic heterogeneity of the disease and supported drug testing across clinically relevant agents.

Read the paper →DOI: 10.1158/1078-0432.CCR-18-0409

Esophageal cancer

Organoid cultures recapitulate esophageal adenocarcinoma heterogeneity providing a model for clonality studies and precision therapeutics

Li X, Francies HE, Secrier M, et al. · Nature Communications, 2018; 9: 2983

Clinically annotated esophageal adenocarcinoma organoids reproducing the mutations, copy-number changes, and clonal architecture of the primary tumors, with medium-throughput drug sensitivity testing demonstrating their value as a precision-therapeutics screening tool.

Read the paper →DOI: 10.1038/s41467-018-05190-9

Review

Organoids in cancer research

Drost J, Clevers H. · Nature Reviews Cancer, 2018; 18(7): 407–418

The standard review of organoid cancer models: why physiologically relevant 3D human models translate basic research into treatment regimens more efficiently than conventional systems, and where the technology is heading.

Read the paper →DOI: 10.1038/s41568-018-0007-6

Liver cancer

Human primary liver cancer–derived organoid cultures for disease modeling and drug screening

Broutier L, Mastrogiovanni G, Verstegen MMA, et al. · Nature Medicine, 2017; 23(12): 1424–1435

Organoids from the major primary liver cancer subtypes retained the histology and molecular features of their tissue of origin even in long-term culture, and drug screening on them surfaced a candidate therapeutic vulnerability: platform utility beyond the colorectal setting.

Read the paper →DOI: 10.1038/nm.4438

Perspective

Functional precision cancer medicine—moving beyond pure genomics

Letai A. · Nature Medicine, 2017; 23(9): 1028–1035

The case for functional testing: genomics alone leaves most patients without an actionable match, while directly perturbing living tumor cells with candidate therapies yields decision-grade information. The conceptual backbone of functional precision oncology.

Read the paper →DOI: 10.1038/nm.4389

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