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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

 Melissa L Johnson  ;  Zanete Zvirbule  ;  Konstantin Laktionov  ;  Aslaug Helland  ;  Byoung Chul Cho  ;  Vanesa Gutierrez  ;  Benoît Colinet  ;  Herve Lena  ;  Martin Wolf  ;  Maya Gottfried  ;  Isamu Okamoto  ;  Cor van der Leest  ;  Patricia Rich  ;  Jen-Yu Hung  ;  Christina Appenzeller  ;  Zhaowen Sun  ;  David Maag  ;  Yan Luo  ;  Caroline Nickner  ;  Alena Vajikova  ;  Philip Komarnitsky  ;  Jair Bar 
 JOURNAL OF THORACIC ONCOLOGY, Vol.16(9) : 1570-1581, 2021-09 
Journal Title
Issue Date
Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Benzodiazepinones / therapeutic use ; Double-Blind Method ; Humans ; Immunoconjugates* / therapeutic use ; Lung Neoplasms* / drug therapy ; Middle Aged ; Platinum / therapeutic use
DLL3 ; Maintenance ; Phase 3 ; Platinum-based chemotherapy ; Rovalpituzumab tesirine ; Small cell lung cancer
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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