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A Phase 1 study of gefitinib combined with durvalumab in EGFR TKI-naive patients withEGFRmutation-positive locally advanced/metastatic non-small-cell lung cancer

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dc.contributor.authorCreelan, Benjamin C.-
dc.contributor.authorYeh, Tammie C.-
dc.contributor.authorKim, Sang-We-
dc.contributor.authorNogami, Naoyuki-
dc.contributor.authorKim, Dong-Wan-
dc.contributor.authorChow, Laura Q. M.-
dc.contributor.authorKanda, Shintaro-
dc.contributor.authorTaylor, Rosemary-
dc.contributor.authorTang, Weifeng-
dc.contributor.authorTang, Mei-
dc.contributor.authorAngell, Helen K.-
dc.contributor.authorRoudier, Martine P.-
dc.contributor.authorMarotti, Marcelo-
dc.contributor.authorGibbons, Don L.-
dc.date.accessioned2022-04-20T10:27:51Z-
dc.date.available2022-04-20T10:27:51Z-
dc.date.issued2021-01-
dc.identifier.citationBritish Journal of Cancer, Vol.124 No.2, pp.383-390-
dc.identifier.issn0007-0920-
dc.identifier.other122024-
dc.identifier.urihttps://hdl.handle.net/10371/179091-
dc.description.abstractBackground EGFR tyrosine kinase inhibitors (TKIs) induce cytolysis and release of tumour proteins, which can stimulate antigen-specific T cells. The safety and efficacy of durvalumab and gefitinib in combination for TKI-naive patients with advancedEGFRm NSCLC was evaluated. Methods This Phase 1 open-label, multicentre trial (NCT02088112) was conducted in 56 patients with NSCLC. Dose expansion permitted TKI-naive patients, primarily with activating L858R or Ex19delEGFRm. Arms 1 + 1a received concurrent therapy; Arm 2 received 4 weeks of gefitinib induction followed by concurrent therapy. Results From dose escalation, the recommended dose of durvalumab was 10 mg/kg Q2W with 250 mg QD gefitinib. Pharmacokinetics were as expected, consistent with inhibition of soluble PD-L1 and no treatment-emergent immunogenicity. In dose expansion, 35% of patients had elevated liver enzymes leading to drug discontinuation. In Arms 1 + 1a, objective response rate was 63.3% (95% CI: 43.9-80.1), median progression-free survival (PFS) was 10.1 months (95% CI: 5.5-15.2) and median response duration was 9.2 months (95% CI: 3.7-14.0). Conclusions Durvalumab and gefitinib in combination had higher toxicity than either agent alone. No significant increase in PFS was detected compared with historical controls. Therefore, concurrent PD-L1 inhibitors with gefitinib should be generally avoided in TKI-naive patients withEGFRm NSCLC.-
dc.titleA Phase 1 study of gefitinib combined with durvalumab in EGFR TKI-naive patients withEGFRmutation-positive locally advanced/metastatic non-small-cell lung cancer-
dc.typeArticle-
dc.contributor.AlternativeAuthor김동완-
dc.identifier.doi10.1038/s41416-020-01099-7-
dc.citation.journaltitleBritish Journal of Cancer-
dc.identifier.scopusid2-s2.0-85092048603-
dc.citation.endpage390-
dc.citation.number2-
dc.citation.startpage383-
dc.citation.volume124-
dc.identifier.rimsid122024-
dc.identifier.sci000575032800002-
dc.description.isOpenAccessY-
dc.contributor.affiliatedAuthorKim, Dong-Wan-
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