An adaptive, biomarker-directed platform study of durvalumab in combination with targeted therapies in advanced urothelial cancer.

Antibodies, Monoclonal / therapeutic use Antineoplastic Agents, Immunological / therapeutic use Antineoplastic Combined Chemotherapy Protocols / therapeutic use B7-H1 Antigen / antagonists & inhibitors Benzamides / therapeutic use Biomarkers, Tumor / blood Humans Mechanistic Target of Rapamycin Complex 1 / antagonists & inhibitors Mechanistic Target of Rapamycin Complex 2 / antagonists & inhibitors Molecular Targeted Therapy / methods Morpholines / therapeutic use Phosphatidylinositol 3-Kinases / genetics Phthalazines / therapeutic use Piperazines / therapeutic use Poly (ADP-Ribose) Polymerase-1 / antagonists & inhibitors Progression-Free Survival Pyrimidines / therapeutic use Receptors, Fibroblast Growth Factor / antagonists & inhibitors TOR Serine-Threonine Kinases / genetics Urologic Neoplasms / drug therapy Urothelium / pathology

Journal

Nature medicine

ISSN: 1546-170X

Titre abrégé: Nat Med

Pays: United States

ID NLM: 9502015

Informations de publication

Date de publication:
05 2021

Historique:

received: 29 05 2020

accepted: 11 03 2021

pubmed: 5 5 2021

medline: 24 6 2021

entrez: 4 5 2021

Statut: ppublish

Résumé

Durvalumab is a programmed death-ligand 1 (PD-L1) inhibitor with clinical activity in advanced urothelial cancer (AUC)

Identifiants

DOI: 10.1038/s41591-021-01317-6 PMID: 33941921

pubmed: 33941921

doi: 10.1038/s41591-021-01317-6

pii: 10.1038/s41591-021-01317-6

doi:

Substances chimiques

Antibodies, Monoclonal 0

Antineoplastic Agents, Immunological 0

B7-H1 Antigen 0

Benzamides 0

Biomarkers, Tumor 0

CD274 protein, human 0

Morpholines 0

Phthalazines 0

Piperazines 0

Pyrimidines 0

Receptors, Fibroblast Growth Factor 0

vistusertib 0BSC3P4H5X

durvalumab 28X28X9OKV

PARP1 protein, human EC 2.4.2.30

Poly (ADP-Ribose) Polymerase-1 EC 2.4.2.30

MTOR protein, human EC 2.7.1.1

Mechanistic Target of Rapamycin Complex 1 EC 2.7.11.1

Mechanistic Target of Rapamycin Complex 2 EC 2.7.11.1

TOR Serine-Threonine Kinases EC 2.7.11.1

olaparib WOH1JD9AR8

Banques de données

ClinicalTrials.gov

['NCT02546661']

Types de publication

Clinical Trial, Phase I Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

793-801

Commentaires et corrections

Type : CommentIn

Références

Powles, T. et al. Efficacy and safety of durvalumab in locally advanced or metastatic urothelial carcinoma: updated results from a phase 1/2 open-label study. JAMA Oncol. 3, e172411 (2017).

doi: 10.1001/jamaoncol.2017.2411

Grivas, P. & Yu, E. Y. Role of targeted therapies in management of metastatic urothelial cancer in the era of immunotherapy. Curr. Treat. Options Oncol. 20, 67 (2019).

doi: 10.1007/s11864-019-0665-y

Robertson, A. G. et al. Comprehensive molecular characterization of muscle-invasive bladder cancer. Cell 171, 540–556 (2017).

doi: 10.1016/j.cell.2017.09.007

Garcia, J. A. & Danielpour, D. Mammalian target of rapamycin inhibition as a therapeutic strategy in the management of urologic malignancies. Mol. Cancer Ther. 7, 1347–1354 (2008).

doi: 10.1158/1535-7163.MCT-07-2408

Teo, M. Y. et al. DNA damage response and repair gene alterations are associated with improved survival in patients with platinum-treated advanced urothelial carcinoma. Clin. Cancer Res. 23, 3610–3618 (2017).

doi: 10.1158/1078-0432.CCR-16-2520

von der Maase, H. et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J. Clin. Oncol. 18, 3068–3077 (2000).

doi: 10.1200/JCO.2000.18.17.3068

Bellmunt, J. et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N. Engl. J. Med. 376, 1015–1026 (2017).

doi: 10.1056/NEJMoa1613683

Jones, R. J. et al. Randomized phase II study investigating pazopanib versus weekly paclitaxel in relapsed or progressive urothelial cancer. J. Clin. Oncol. 35, 1770–1777 (2017).

doi: 10.1200/JCO.2016.70.7828

Loriot, Y. et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N. Engl. J. Med. 381, 338–348 (2019).

doi: 10.1056/NEJMoa1817323

Wagle, N. et al. Activating mTOR mutations in a patient with an extraordinary response on a phase I trial of everolimus and pazopanib. Cancer Discov. 4, 546–553 (2014).

doi: 10.1158/2159-8290.CD-13-0353

Necchi, A. et al. Exceptional response to olaparib in BRCA2-altered urothelial carcinoma after PD-L1 inhibitor and chemotherapy failure. Eur. J. Cancer 96, 128–130 (2018).

doi: 10.1016/j.ejca.2018.03.021

Friedlander, M. et al. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 20, 1306–1315 (2019).

doi: 10.1016/S1470-2045(19)30396-1

Bellmunt, J. et al. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J. Clin. Oncol. 28, 1850–1855 (2010).

doi: 10.1200/JCO.2009.25.4599

Massard, C. et al. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J. Clin. Oncol. 34, 3119–3125 (2016).

doi: 10.1200/JCO.2016.67.9761

Bellmunt, J., Powles, T. & Vogelzang, N. J. A review on the evolution of PD-1/PD-L1 immunotherapy for bladder cancer: the future is now. Cancer Treat. Rev. 54, 58–67 (2017).

doi: 10.1016/j.ctrv.2017.01.007

Zhang, Q. et al. Prognostic and predictive impact of circulating tumor DNA in patients with advanced cancers treated with immune checkpoint blockade. Cancer Discov. 10, 1842–1853 (2020).

Christensen, E. et al. Early detection of metastatic relapse and monitoring of therapeutic efficacy by ultra-deep sequencing of plasma cell-free DNA in patients with urothelial bladder carcinoma. J. Clin. Oncol. 37, 1547–1557 (2019).

doi: 10.1200/JCO.18.02052

Mariathasan, S. et al. TGFbeta attenuates tumour response to PD-L1 blockade by contributing to exclusion of T cells. Nature 554, 544–548 (2018).

doi: 10.1038/nature25501

Taber, A. et al. Molecular correlates of cisplatin-based chemotherapy response in muscle invasive bladder cancer by integrated multi-omics analysis. Nat. Commun. 11, 4858 (2020).

doi: 10.1038/s41467-020-18640-0

Choi, W. et al. Identification of distinct basal and luminal subtypes of muscle-invasive bladder cancer with different sensitivities to frontline chemotherapy. Cancer Cell 25, 152–165 (2014).

doi: 10.1016/j.ccr.2014.01.009

Kamoun, A. et al. A consensus molecular classification of muscle-invasive bladder cancer. Eur. Urol. 77, 420–433 (2020).

doi: 10.1016/j.eururo.2019.09.006

Rosenberg, J. E. et al. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet 387, 1909–1920 (2016).

doi: 10.1016/S0140-6736(16)00561-4

Grivas, P. et al. Rucaparib for recurrent, locally advanced, or metastatic urothelial carcinoma (mUC): results from ATLAS, a phase II open-label trial. J. Clin. Oncol. 38, 440–440 (2020).

doi: 10.1200/JCO.2020.38.6_suppl.440

Update on the Phase III NEPTUNE Trial of Imfinzi Plus Tremelimumab in Stage IV Non-small Cell Lung Cancer (AstraZeneca, 2019); https://www.astrazeneca.com/media-centre/press-releases/2019/update-on-the-phase-iii-neptune-trial-of-imfinzi-plus-tremelimumab-in-stage-iv-non-small-cell-lung-cancer-21082019.html

Powles, T. et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet 391, 748–757 (2018).

doi: 10.1016/S0140-6736(17)33297-X

Powles, T. et al. Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial. Nat. Med. 25, 1706–1714 (2019).

doi: 10.1038/s41591-019-0628-7

Pairawan, S. et al. Cell-free circulating tumor DNA variant allele frequency associates with survival in metastatic cancer. Clin. Cancer Res. 26, 1924–1931 (2020).

doi: 10.1158/1078-0432.CCR-19-0306

Vandekerkhove, G. et al. Plasma ctDNA is a tumor tissue surrogate and enables clinical-genomic stratification of metastatic bladder cancer. Nat. Commun. 12, 184 (2021).

doi: 10.1038/s41467-020-20493-6

Xing, P. et al. Co-mutational assessment of circulating tumour DNA (ctDNA) during osimertinib treatment for T790M mutant lung cancer. J. Cell Mol. Med. 23, 6812–6821 (2019).

doi: 10.1111/jcmm.14565

Leonetti, A. et al. Resistance mechanisms to osimertinib in EGFR-mutated non-small cell lung cancer. Br. J. Cancer 121, 725–737 (2019).

doi: 10.1038/s41416-019-0573-8

Antonescu, C. R. et al. Acquired resistance to imatinib in gastrointestinal stromal tumor occurs through secondary gene mutation. Clin. Cancer Res. 11, 4182–4190 (2005).

doi: 10.1158/1078-0432.CCR-04-2245