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Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC.
- Source :
-
New England Journal of Medicine . 10/1/2020, Vol. 383 Issue 14, p1328-1339. 12p. - Publication Year :
- 2020
-
Abstract
- <bold>Background: </bold>The efficacy and safety of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those of platinum-based chemotherapy, as first-line treatment for patients with metastatic non-small-cell lung cancer (NSCLC) with PD-L1 expression are not known.<bold>Methods: </bold>We conducted a randomized, open-label, phase 3 trial involving patients with metastatic nonsquamous or squamous NSCLC who had not previously received chemotherapy and who had PD-L1 expression on at least 1% of tumor cells or at least 1% of tumor-infiltrating immune cells as assessed by the SP142 immunohistochemical assay. Patients were assigned in a 1:1 ratio to receive atezolizumab or chemotherapy. Overall survival (primary end point) was tested hierarchically according to PD-L1 expression status among patients in the intention-to-treat population whose tumors were wild-type with respect to EGFR mutations or ALK translocations. Within the population with EGFR and ALK wild-type tumors, overall survival and progression-free survival were also prospectively assessed in subgroups defined according to findings on two PD-L1 assays as well as by blood-based tumor mutational burden.<bold>Results: </bold>Overall, 572 patients were enrolled. In the subgroup of patients with EGFR and ALK wild-type tumors who had the highest expression of PD-L1 (205 patients), the median overall survival was longer by 7.1 months in the atezolizumab group than in the chemotherapy group (20.2 months vs. 13.1 months; hazard ratio for death, 0.59; P = 0.01). Among all the patients who could be evaluated for safety, adverse events occurred in 90.2% of the patients in the atezolizumab group and in 94.7% of those in the chemotherapy group; grade 3 or 4 adverse events occurred in 30.1% and 52.5% of the patients in the respective groups. Overall and progression-free survival favored atezolizumab in the subgroups with a high blood-based tumor mutational burden.<bold>Conclusions: </bold>Atezolizumab treatment resulted in significantly longer overall survival than platinum-based chemotherapy among patients with NSCLC with high PD-L1 expression, regardless of histologic type. (Funded by F. Hoffmann-La Roche/Genentech; IMpower110 ClinicalTrials.gov number, NCT02409342.). [ABSTRACT FROM AUTHOR]
- Subjects :
- *THERAPEUTIC use of monoclonal antibodies
*THERAPEUTIC use of antineoplastic agents
*LUNG cancer
*RESEARCH
*GENETIC mutation
*CARBOPLATIN
*RESEARCH methodology
*LUNG tumors
*DEOXYCYTIDINE
*ANTINEOPLASTIC agents
*MONOCLONAL antibodies
*EVALUATION research
*MEDICAL cooperation
*COMPARATIVE studies
*RANDOMIZED controlled trials
*SURVIVAL analysis (Biometry)
*CISPLATIN
*STATISTICAL sampling
*SQUAMOUS cell carcinoma
Subjects
Details
- Language :
- English
- ISSN :
- 00284793
- Volume :
- 383
- Issue :
- 14
- Database :
- Academic Search Index
- Journal :
- New England Journal of Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 146355806
- Full Text :
- https://doi.org/10.1056/NEJMoa1917346