Abstract 1808TiP
Background
Despite many attempts to develop effective systemic therapies for ES-SCLC, very little progress has been made in the last several decades. According to the results of the IMpower133 trial (N Engl J Med 2018), the combination of the PD-L1 inhibitor ATZ and Cb-Eto should be currently considered the standard front-line treatment for ES-SCLC. This combination was associated with longer progression free survival (PFS) and overall survival (OS) compared to placebo-Cb-Eto. The median OS at follow-up of 22.9 months confirmed the data of primary analysis with 12.3 months in the ATZ arm vs 10.3 months in the placebo arm (HR, 0.76; 95% CI, 0.60-0.95; P = .0154) (Reck et al. ESMO Congress 2019). The safety profile of ATZ combination has been consistent with the defined toxic effects of the individual agents. Additional studies that evaluate the safety and efficacy also in subsets of patients not included in the pivotal trial can give further support to daily clinical practice.
Trial design
MAURIS is a multi-center, open-label, one arm, phase IIIb trial that evaluate the safety and efficacy of ATZ plus Cb and Eto in patients with newly diagnosed ES- SCLC. Unlike the IMpower133 trial, also patients with ECOG PS2 and untreated asymptomatic brain metastases are eligible for this study. Patients will be addressed to receive chemotherapy plus ATZ 1200 mg every 3 weeks for a total of 4–6 cycles in the induction phase, followed by ATZ maintenance every 3 weeks up to progression, unacceptable toxicity or clinical deterioration. Thoracic consolidation radiotherapy is allowed. Primary endpoints are incidence of serious adverse events (SAEs) related to treatment and incidence of serious and non-serious immune-mediated AEs among patients receiving at least one dose of study therapy. Secondary endpoints include efficacy by RECIST v1.1 (PFS, overall response rate (ORR) and OS. Enrollment is ongoing with 131 out of 150 recruited in 26 Italian centers.
Clinical trial identification
NCT04028050.
Editorial acknowledgement
Legal entity responsible for the study
Roche.
Funding
Roche.
Disclosure
G. Martini: Advisory/Consultancy, Research grant/Funding (self): Merck; Advisory/Consultancy, Research grant/Funding (self): Bayer; Advisory/Consultancy, Research grant/Funding (institution): Amgen; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy: Servier; Research grant/Funding (institution): Ipsen. E. Bria: Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Celgene; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Helsinn; Advisory/Consultancy: Eli-Lilly; Advisory/Consultancy: BMS; Advisory/Consultancy: Novartis; Research grant/Funding (institution): AIRC, IASLC, Cariverona. C. Gridelli: Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca, BMS, Merck, Roche. M.C. Garassino: Advisory/Consultancy: AstraZeneca, BMS, Merck, Roche, Sharp & Dohme, Boehringer Ingelheim, Eli Lilly. A. Ardizzoni: Honoraria (self): Eli Lilly, Pfizer; Honoraria (self), Honoraria (institution), Advisory/Consultancy: BMS; Advisory/Consultancy: MSD, AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Roche; Research grant/Funding (institution): Celgene. F. De Marinis: Honoraria (self), Advisory/Consultancy: Roche, AstraZeneca; Advisory/Consultancy: Takeda; Research grant/Funding (self): Boehringer Ingelheim; Honoraria (institution), Research grant/Funding (self): Merck Sharp and Dohme.