Cited 63 times in
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
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2021-09-29T02:25:37Z | - |
dc.date.available | 2021-09-29T02:25:37Z | - |
dc.date.issued | 2021-09 | - |
dc.identifier.issn | 1556-0864 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/184885 | - |
dc.description.abstract | Introduction: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF THORACIC ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use | - |
dc.subject.MESH | Benzodiazepinones / therapeutic use | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunoconjugates* / therapeutic use | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Platinum / therapeutic use | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Melissa L Johnson | - |
dc.contributor.googleauthor | Zanete Zvirbule | - |
dc.contributor.googleauthor | Konstantin Laktionov | - |
dc.contributor.googleauthor | Aslaug Helland | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Vanesa Gutierrez | - |
dc.contributor.googleauthor | Benoît Colinet | - |
dc.contributor.googleauthor | Herve Lena | - |
dc.contributor.googleauthor | Martin Wolf | - |
dc.contributor.googleauthor | Maya Gottfried | - |
dc.contributor.googleauthor | Isamu Okamoto | - |
dc.contributor.googleauthor | Cor van der Leest | - |
dc.contributor.googleauthor | Patricia Rich | - |
dc.contributor.googleauthor | Jen-Yu Hung | - |
dc.contributor.googleauthor | Christina Appenzeller | - |
dc.contributor.googleauthor | Zhaowen Sun | - |
dc.contributor.googleauthor | David Maag | - |
dc.contributor.googleauthor | Yan Luo | - |
dc.contributor.googleauthor | Caroline Nickner | - |
dc.contributor.googleauthor | Alena Vajikova | - |
dc.contributor.googleauthor | Philip Komarnitsky | - |
dc.contributor.googleauthor | Jair Bar | - |
dc.identifier.doi | 10.1016/j.jtho.2021.03.012 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J01909 | - |
dc.identifier.eissn | 1556-1380 | - |
dc.identifier.pmid | 33823285 | - |
dc.subject.keyword | DLL3 | - |
dc.subject.keyword | Maintenance | - |
dc.subject.keyword | Phase 3 | - |
dc.subject.keyword | Platinum-based chemotherapy | - |
dc.subject.keyword | Rovalpituzumab tesirine | - |
dc.subject.keyword | Small cell lung cancer | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 16 | - |
dc.citation.number | 9 | - |
dc.citation.startPage | 1570 | - |
dc.citation.endPage | 1581 | - |
dc.identifier.bibliographicCitation | JOURNAL OF THORACIC ONCOLOGY, Vol.16(9) : 1570-1581, 2021-09 | - |
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