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Clinical Trial
. 2024 May 3;29(5):e690-e698.
doi: 10.1093/oncolo/oyad342.

Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial

Emilio Bria  1 , Floriana Morgillo  2 , Marina Chiara Garassino  3 , Fortunato Ciardiello  4 , Andrea Ardizzoni  5 , Alessio Stefani  6 , Francesco Verderame  7 , Alessandro Morabito  8 , Antonio Chella  9 , Giuseppe Tonini  10 , Marina Gilli  11 , Ester Del Signore  12 , Rossana Berardi  13 , Manlio Mencoboni  14 , Alessandra Bearz  15 , Angelo Delmonte  16 , Marta Rita Migliorino  17 , Cesare Gridelli  18 , Antonio Pazzola  19 , Manuela Iero  20 , Filippo De Marinis  21
Affiliations
Clinical Trial

Atezolizumab Plus Carboplatin and Etoposide in Patients with Untreated Extensive-Stage Small-Cell Lung Cancer: Interim Results of the MAURIS Phase IIIb Trial

Emilio Bria et al. Oncologist. .

Abstract

Background: MAURIS is an Italian multicenter, open-label, phase IIIb ongoing trial, aiming at evaluating the safety and effectiveness of atezolizumab + carboplatin/etoposide in patients with newly diagnosed, extensive-stage small-cell lung cancer (ES-SCLC). The primary objective is the safety evaluation.

Materials and methods: Patients received atezolizumab + carboplatin/etoposide Q3W for 4-6 cycles in the induction phase, followed by atezolizumab maintenance Q3W. We presented the interim analysis on safety (referring to the induction phase) and clinical effectiveness, in all patients (N = 154) and in subgroups that received ≤3 (N = 23), 4 (N = 43), and 5-6 cycles (N = 89) of induction.

Results: At a median follow-up of 10.5 months, 139 patients (90.3%) discontinued treatment. Serious adverse events occurred in 29.9% of patients overall, and the rate was lower in patients with 5-6 cycles (19.1%) than in those with 4 (34.9%) or ≤3 (63.6%) cycles. Immune-mediated adverse events were reported in 14.9%, 15.7%, 11.6%, and 18.2% of patients, overall and by subgroup, respectively. The median overall survival and progression-free survival were 10.7 and 5.5 months, respectively. Overall, 111 patients (71.6%) had a tumor response.

Conclusions: Interim results provide further evidences about safety and efficacy profile of atezolizumab + carboplatin/etoposide treatment in a ES-SCLC patient population closer to that observed in clinical practice.

Clinical trial registration: Eudract No. 2019-001146-17, NCT04028050.

Keywords: atezolizumab; chemotherapy; extensive-stage small cell lung cancer; induction.

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Conflict of interest statement

Prof. Bria has received grants or contracts from Italian Association for Cancer Research, Università Cattolica del Sacro Cuore, Italian Ministry of Health, AstraZeneca, and Roche; honoraria for lectures from Merck-Sharp & Dome, AstraZeneca, Pfizer, Eli-Lilly, Bristol-Myers Squibb, Novartis, and Roche; and has been member of the Data Safety Monitoring Board or Advisory Board of Merck Sharp & Dome, Pfizer, Novartis, Bristol-Myers Squibb, AstraZeneca, and Roche. Prof. Morgillo has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from MSD International GmbH, BMS, Boehringer, Ingelheim Italia S.p.A., and Roche, and support for attending meetings and/or travel from MSD. Prof. Garassino has received consulting fees from AstraZeneca, MSD International GmbH, Bayer, BMS, Boehringer Ingelheim Italia S.p.A., Celgene, Eli Lilly, Incyte, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron, Merck, Blueprint, Jansenn, Sanofi, AbbVie, and BeiGenius, and payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from AstraZeneca, MSD International GmbH, Merck, Celgene, Eli Lilly, Incyte, and Roche. Prof. Ciardiello has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Merck, MSD, Servier, and Pierre Fabre, and has been a member of the Data Safety Monitoring Board or Advisory Board of MSD, Pierre Fabre, Servier, Merck, Roche, and Pfizer. Prof. Ardizzoni has received honoraria for lectures from BMS, AstraZeneca, and MSD, and has been a member of the Advisory Board of Roche, AstraZeneca, BMS, Sanofi, and Eli Lilly. Prof. Verderame has received grants or contracts from Roche, AstraZeneca, GSK, MSD, Janssen, Servier, and Takeda, and support for attending meetings and/or travel from Janssen, Roche, and MSD. Dr. Morabito has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Roche, BMS, AstraZeneca, MSD, Novartis, Takeda, Lilly, Pfizer, and Boehringer, and has been member of the Data Safety Monitoring Board or Advisory Board of AstraZeneca, Takeda, Pfizer, and MSD. Dr. Tonini has been a member of the Advisory Board of Molteni, Novartis, MSD, and Pharmamar. Dr. Del Signore has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Roche. Prof. Berardi has received grants or contracts, consulting fees, payment, or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from AstraZeneca, Boeringher, MSD, Lilly, Roche, Amgen, GSK, Eisai, and BMS; has been a member of the Data Safety Monitoring Board or Advisory Board of AstraZeneca, Boeringher, MSD, Lilly, Roche, Amgen, GSK, Eisai, and BMS; an expert member of AIFA Oncological Team Board, President of FONICAP, Member of AIOM National Council Board, and President LOTO ODV Scientific Committee; and had a leadership or fiduciary role in AstraZeneca, Boeringher, MSD, Lilly, Roche, Amgen, GSK, Eisai, and BMS. Dr. Mencoboni has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events and support for attending meetings and/or travel from AstraZeneca, Pfizer, Roche, and Novartis. Dr. Bearz has received consulting fees from Pfizer and honoraria for lectures from Pfizer, MSD, Roche, and AstraZeneca and has been a member of the Advisory Board of Lilly, AstraZeneca, Pfizer, and Roche. Dr. Delmonte has received support for attending meetings and/or travel from MSD and Takeda, and has been a member of the Data Safety Monitoring Board or Advisory Board of Novartis, Pfizer, and Immunocore. Dr. Migliorino has received payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Roche, AstraZeneca, Pfizer, Sanofi, Novartis, and Eli Lilly, and support for attending meetings and/or travel from Novartis, Sanofi, and Takeda. Dr. Gridelli has received consulting fees from Menarini and Roche; payment or honoraria for lectures, presentations, speakers' bureaus, manuscript writing, or educational events from Roche, AstraZeneca, MSD, BMS, Amgen, Pfizer, GSK, Takeda, Kyriopharm, Sanofi, Boehringer, and Eli Lilly; and has been member of Data Safety Monitoring Board or Advisory Board of Roche, AstraZeneca, MSD, BMS, Amgen, Pfizer, GSK, Takeda, Kyriopharm, Sanofi, Boehringer, and Eli Lilly. Dr. Iero is an employee of Roche Farma Spa. Prof. De Marinis has received payment or honoraria for speakers’ bureaus and served as a member of the Advisory Board from Roche, AstraZeneca, BMS, Novartis, and Merck. Dr. Chella, Dr. Gilli, Dr. Pazzola, Dr. Stefani declare no potential competing interests.

Figures

Figure 1.
Figure 1.
Most common (ie, reported in ≥5% of patients overall) treatment-related (any component) TEAEs by PT.
Figure 2.
Figure 2.
Summary of results of OS overall and by subgroup: Kaplan-Meier estimate (ITT set). Abbreviation: OS, overall survival.
Figure 3.
Figure 3.
Summary of results of PFS overall and by subgroup: Kaplan-Meier estimate (ITT set). Abbreviation: PFS, progression-free survival.
See this image and copyright information in PMC

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