RT Journal Article
T1 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.
A1 Johnson, Melissa L
A1 Zvirbule, Zanete
A1 Laktionov, Konstantin
A1 Helland, Aslaug
A1 Cho, Byoung Chul
A1 Gutierrez, Vanesa
A1 Colinet, Benoît
A1 Lena, Herve
A1 Wolf, Martin
A1 Gottfried, Maya
A1 Okamoto, Isamu
A1 van der Leest, Cor
A1 Rich, Patricia
A1 Hung, Jen-Yu
A1 Appenzeller, Christina
A1 Sun, Zhaowen
A1 Maag, David
A1 Luo, Yan
A1 Nickner, Caroline
A1 Vajikova, Alena
A1 Komarnitsky, Philip
A1 Bar, Jair
K1 DLL3
K1 Maintenance
K1 Phase 3
K1 Platinum-based chemotherapy
K1 Rovalpituzumab tesirine
K1 Small cell lung cancer
AB 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. 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. 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  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.
YR 2021
FD 2021-04-03
LK http://hdl.handle.net/10668/17534
UL http://hdl.handle.net/10668/17534
LA en
DS RISalud
RD Apr 11, 2025