2026-05-15T01:49:54Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/83872024-11-29T23:54:51Zcom_20.500.12105_2173com_20.500.12105_2051col_20.500.12105_19597
Repisalud
author
Peters, Solange
author
Gettinger, Scott
author
Johnson, Melissa L
author
Jänne, Pasi A
author
Garassino, Marina C
author
Christoph, Daniel
author
Toh, Chee Keong
author
Rizvi, Naiyer A
author
Chaft, Jamie E
author
Carcereny Costa, Enric
author
Patel, Jyoti D
author
Chow, Laura Q M
author
Koczywas, Marianna
author
Ho, Cheryl
author
Früh, Martin
author
van den Heuvel, Michel
author
Rothenstein, Jeffrey
author
Reck, Martin
author
Paz Ares, Luis Gonzaga
author
Shepherd, Frances A
author
Kurata, Takayasu
author
Li, Zhengrong
author
Qiu, Jiaheng
author
Kowanetz, Marcin
author
Mocci, Simonetta
author
Shankar, Geetha
author
Sandler, Alan
author
Felip, Enriqueta
funder
Genetic Engineering Tech (Genentech)
funder
National Institutes of Health (Estados Unidos)
2019-09-30T08:40:42Z
2019-09-30T08:40:42Z
2017-08-20
J Clin Oncol. 2017;35(24):2781-2789
10.1200/JCO.2016.71.9476
1527-7755
0732-183X
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
28609226
http://hdl.handle.net/20.500.12105/8387
Purpose BIRCH was designed to examine the efficacy of atezolizumab, a humanized anti-programmed death-ligand 1 (PD-L1) monoclonal antibody, in advanced non-small-cell lung cancer (NSCLC) across lines of therapy. Patients were selected on the basis of PD-L1 expression on tumor cells (TC) or tumor-infiltrating immune cells (IC). Patients and Methods Eligible patients had advanced-stage NSCLC, no CNS metastases, and zero to two or more lines of prior chemotherapy. Patients whose tumors expressed PD-L1 using the SP142 immunohistochemistry assay on ≥ 5% of TC or IC (TC2/3 or IC2/3 [TC or IC ≥ 5% PD-L1-expressing cells, respectively]) were enrolled. Atezolizumab 1,200 mg was administered intravenously every 3 weeks. Efficacy-evaluable patients (N = 659) comprised three cohorts: first line (cohort 1; n = 139); second line (cohort 2; n = 268); and third line or higher (cohort 3; n = 252). The primary end point was independent review facility-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1). Secondary end points included median duration of response, progression-free survival, and overall survival (OS). Results BIRCH met its primary objective of demonstrating a significant ORR versus historical controls. With a minimum of 12 months of follow-up, the independent review facility-assessed ORR was 18% to 22% for the three cohorts, and 26% to 31% for the TC3 or IC3 subgroup; most responses are ongoing. Responses occurred regardless of EGFR or KRAS mutation status. The median OS from an updated survival analysis (minimum of 20 month follow up) for cohort 1 was 23.5 months (26.9 months for TC3 or IC3 patients); the median OS in cohorts 2 and 3 was 15.5 and 13.2 months, respectively. The safety profile was similar across cohorts and consistent with previous atezolizumab monotherapy trials. Conclusion BIRCH demonstrated responses with atezolizumab monotherapy in patients with PD-L1-selected advanced NSCLC, with good tolerability. PD-L1 status may serve as a predictive biomarker for identifying patients most likely to benefit from atezolizumab.
eng
Phase II Trial of Atezolizumab As First-Line or Subsequent Therapy for Patients With Programmed Death-Ligand 1-Selected Advanced Non-Small-Cell Lung Cancer (BIRCH)
journal article
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