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Rovalpituzumab Tesirine as a Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Patients With Extensive-Stage-SCLC: Results From the Phase 3 MERU Study

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dc.contributor.author조병철-
dc.date.accessioned2021-09-29T02:25:37Z-
dc.date.available2021-09-29T02:25:37Z-
dc.date.issued2021-09-
dc.identifier.issn1556-0864-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/184885-
dc.description.abstractIntroduction: Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate targeting DLL3, an atypical Notch ligand expressed in SCLC tumors. We evaluated the efficacy of Rova-T versus placebo as maintenance therapy in patients with extensive-stage-SCLC after platinum-based chemotherapy. Methods: MERU was a phase 3 randomized, double-blinded, placebo-controlled study. Patients without disease progression after four cycles of platinum-based, front-line chemotherapy were randomized in a 1:1 ratio to receive 0.3 mg/kg Rova-T or placebo (every 6 wk, omitted every third cycle). Primary efficacy end points were progression-free survival (PFS) evaluated by the Central Radiographic Assessment Committee and overall survival (OS) in patients with DLL3-high tumors. Results: Median age of all randomized patients (N = 748) was 64 years; 78% had TNM stage IV disease. At futility analysis of the subset with DLL3-high tumors, the hazard ratio for OS was 1.07 (95% confidence interval: 0.84-1.36) favoring the placebo arm, with median OS of 8.5 and 9.8 months in the Rova-T and placebo arms, respectively; futility criteria were met. Rova-T significantly improved PFS versus placebo by investigator assessment (4.0 versus 1.4 mo, hazard ratio = 0.48, p < 0.001). Any-grade adverse events (≥20%) in the Rova-T arm were pleural effusion (27%), decreased appetite (27%), peripheral edema (26%), photosensitivity reaction (25%), fatigue (25%), nausea (22%), and dyspnea (21%). Conclusions: Because of the lack of survival benefit in the Rova-T arm, the study did not meet its primary end point and was terminated early. As a result, the Central Radiographic Assessment Committee evaluation of PFS was not performed. The frequency of grade greater than or equal to 3 and drug-related toxicities were higher with Rova-T versus placebo. Rova-T was associated with unique toxicities, such as pleural and pericardial effusions, photosensitivity reaction, and peripheral edema, which should be carefully considered in the population with extensive-stage-SCLC.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfJOURNAL OF THORACIC ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAntibodies, Monoclonal, Humanized-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / therapeutic use-
dc.subject.MESHBenzodiazepinones / therapeutic use-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHHumans-
dc.subject.MESHImmunoconjugates* / therapeutic use-
dc.subject.MESHLung Neoplasms* / drug therapy-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPlatinum / therapeutic use-
dc.titleRovalpituzumab Tesirine as a Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Patients With Extensive-Stage-SCLC: Results From the Phase 3 MERU Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorMelissa L Johnson-
dc.contributor.googleauthorZanete Zvirbule-
dc.contributor.googleauthorKonstantin Laktionov-
dc.contributor.googleauthorAslaug Helland-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorVanesa Gutierrez-
dc.contributor.googleauthorBenoît Colinet-
dc.contributor.googleauthorHerve Lena-
dc.contributor.googleauthorMartin Wolf-
dc.contributor.googleauthorMaya Gottfried-
dc.contributor.googleauthorIsamu Okamoto-
dc.contributor.googleauthorCor van der Leest-
dc.contributor.googleauthorPatricia Rich-
dc.contributor.googleauthorJen-Yu Hung-
dc.contributor.googleauthorChristina Appenzeller-
dc.contributor.googleauthorZhaowen Sun-
dc.contributor.googleauthorDavid Maag-
dc.contributor.googleauthorYan Luo-
dc.contributor.googleauthorCaroline Nickner-
dc.contributor.googleauthorAlena Vajikova-
dc.contributor.googleauthorPhilip Komarnitsky-
dc.contributor.googleauthorJair Bar-
dc.identifier.doi10.1016/j.jtho.2021.03.012-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ01909-
dc.identifier.eissn1556-1380-
dc.identifier.pmid33823285-
dc.subject.keywordDLL3-
dc.subject.keywordMaintenance-
dc.subject.keywordPhase 3-
dc.subject.keywordPlatinum-based chemotherapy-
dc.subject.keywordRovalpituzumab tesirine-
dc.subject.keywordSmall cell lung cancer-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume16-
dc.citation.number9-
dc.citation.startPage1570-
dc.citation.endPage1581-
dc.identifier.bibliographicCitationJOURNAL OF THORACIC ONCOLOGY, Vol.16(9) : 1570-1581, 2021-09-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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