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 of Clinical Oncology

Volumn 35, Issue 24, 2017, Pages 2781-2789

  Peters, Solange ^a   Gettinger, Scott ^c   Johnson, Melissa L ^d   Jänne, Pasi A ^e   Garassino, Marina C ^f   Christoph, Daniel ^g   Toh, Chee Keong ⁱ   Rizvi, Naiyer A ^j   Chaft, Jamie E ^j,k   Costa, Enric Carcereny ^l   Patel, Jyoti D ^o   Chow, Laura Q M ^p   Koczywas, Marianna ^q   Ho, Cheryl ^s   Früh, Martin ^b   Van Den Heuvel, Michel ^v   Rothenstein, Jeffrey ^t   Reck, Martin ^h   Paz Ares, Luis ^m   Shepherd, Frances A ^u   Kurata, Takayasu ^w   Li, Zhengrong ^r   Qiu, Jiaheng ^r   Kowanetz, Marcin ^r   Mocci, Simonetta ^r   Shankar, Geetha ^r   Sandler, Alan ^r   Felip, Enriqueta ⁿ   more..

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^c YALE CANCER CENTER   (United States)

^d SARAH CANNON RESEARCH INSTITUTE   (United States)

^e DANA FARBER CANCER INSTITUTE   (United States)

^f NATIONAL CANCER INSTITUTE   (Italy)

^g UNIVERSITY HOSPITAL ESSEN   (Germany)

^h GERMAN CENTER FOR LUNG RESEARCH   (Germany)

ⁱ DIVISION OF MEDICAL ONCOLOGY   (Singapore)

^j MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^k WEILL CORNELL MEDICAL COLLEGE   (United States)

^l Centre of Epidemiological Studies on STI HIV and AIDS in Catalonia (CEEISCAT)   (Spain)

^m HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

ⁿ VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^o UNIVERSITY OF CHICAGO   (United States)

^p UNIVERSITY OF WASHINGTON   (United States)

^q CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^r GENENTECH INC   (United States)

^s BRITISH COLUMBIA CANCER AGENCY   (Canada)

^t LAKERIDGE HEALTH CORPORATION   (Canada)

^u PRINCESS MARGARET HOSPITAL   (Canada)

^v ANTONI VAN LEEUWENHOEK HOSPITAL   (Netherlands)

^w KANSAI MEDICAL UNIVERSITY HOSPITAL   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; ATEZOLIZUMAB; BIOLOGICAL MARKER; PROGRAMMED DEATH 1 LIGAND 1; ANTINEOPLASTIC AGENT; CD274 PROTEIN, HUMAN; MONOCLONAL ANTIBODY;

ACUTE CORONARY SYNDROME; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTHRALGIA; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASPIRATION PNEUMONIA; ASTHENIA; BLEEDING; BRAIN INFARCTION; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; COLITIS; CONFERENCE PAPER; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEART ARREST; HEART FAILURE; HUMAN; HYPOTHYROIDISM; IMMUNOCOMPETENT CELL; IMMUNOHISTOCHEMISTRY; INTERNAL HEMORRHAGE; LIVER FAILURE; LUNG INFECTION; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; NAUSEA; NON SMALL CELL LUNG CANCER; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; PRURITUS; RASH; RESPIRATORY DISTRESS; RESPIRATORY FAILURE; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; SEPTIC SHOCK; SIDE EFFECT; TREATMENT DURATION; TREATMENT RESPONSE; TUMOR CELL; BIOSYNTHESIS; CANCER STAGING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; IMMUNOLOGY; INTRAVENOUS DRUG ADMINISTRATION; LUNG NEOPLASMS; MIDDLE AGED; MULTICENTER STUDY; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTIGENS, CD274; ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING;

EID: 85028511452     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2016.71.9476     Document Type: Conference Paper

References (30)

1. Scagliotti GV, Parikh P, von Pawel J, et al: Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapynaive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26:3543-3551, 2008
2. Sandler A, Gray R, Perry MC, et al: Paclitaxelcarboplatin alone or with bevacizumab for nonsmall- cell lung cancer. N Engl J Med 355:2542-2550, 2006
3. Fossella FV, DeVore R, Kerr RN, et al: Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-smallcell lung cancer previously treated with platinumcontaining chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 18:2354-2362, 2000
4. Shepherd FA, Dancey J, Ramlau R, et al: Prospective randomized trial of docetaxel versus best supportive care in patients with non-smallcell lung cancer previously treated with platinumbased chemotherapy. J Clin Oncol 18:2095-2103, 2000
5. Brahmer J, Reckamp KL, Baas P, et al: Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med 373: 123-135, 2015
6. Borghaei H, Paz-Ares L, Horn L, et al: Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. N Engl JMed 373:1627-1639, 2015
7. Garon EB, Rizvi NA, Hui R, et al: Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 372:2018-2028, 2015
8. Gettinger SN, Horn L, Gandhi L, et al: Overall survival and long-term safety of nivolumab (anti-programmed death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small-cell lung cancer. J Clin Oncol 33: 2004-2012, 2015
9. Bristol-Myers Squibb: OPDIVO (nivolumab) prescribing information,May 2016. https://packageinserts.bms.com/pi/pi-opdivo.pdf
10. Merck Sharp & Dohme : KEYTRUDA (pembrolizumab) prescribing information, December 2015. https://www.merck.com/product/usa/pi-circulars/k/keytruda/keytruda-pi.pdf
11. Reck M, Rodríguez-Abreu D, Robinson AG, et al: Pembrolizumab versus chemotherapy for PDL1- positive non-small-cell lung cancer. N Engl J Med 375:1823-1833, 2016
12. Genentech: TECENTRIQ (atezolizumab) prescribing information, April 2017. https://www.gene.com/download/pdf/tecentriq-prescribing.pdf
13. Konishi J, Yamazaki K, Azuma M, et al: B7-H1 expression on non-small cell lung cancer cells and its relationship with tumor-infiltrating lymphocytes and their PD-1 expression. Clin Cancer Res 10:5094-5100, 2004
14. Chen DS, Irving BA, Hodi FS: Molecular pathways: Next-generation immunotherapy-Inhibiting programmed death-ligand 1 and programmed death-1. Clin Cancer Res 18:6580-6587, 2012
15. Chen DS, Mellman I: Oncology meets immunology: The cancer-immunity cycle. Immunity 39: 1-10, 2013
16. Powles T, Eder JP, Fine GD, et al:MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature 515:558-562, 2014
17. Herbst RS, Soria JC, Kowanetz M, et al: Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature 515: 563-567, 2014
18. Adams S, Diamond J, Hamilton E, et al: Safety and clinical activity of atezolizumab (anti- PDL1) in combination with nab-paclitaxel in patients with metastatic triple-negative breast cancer. Presented at San Antonio Breast Cancer Symposium, San Antonio, TX, December 8-12, 2015 (abstr P2-11-06)
19. McDermott DF, Sosman JA, Sznol M, et al: Atezolizumab, an anti-programmed death-ligand 1 antibody, in metastatic renal cell carcinoma: Longterm safety, clinical activity, and immune correlates from a phase Ia study. J Clin Oncol 34:833-842, 2016
20. Rosenberg JE, Hoffman-Censits J, Powles T, et al: Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: A single-arm, multicentre, phase 2 trial. Lancet 387:1909-1920, 2016
21. Fehrenbacher L, Spira A, Ballinger M, et al: Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): A multicentre, open-label, phase 2 randomised controlled trial. Lancet 387:1837-1846, 2016
22. Spigel DR, Chaft JE, Gettinger SN, et al: Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PD-L1-selected patients with non-small cell lung cancer (NSCLC). J Clin Oncol 33, 2015 (suppl; abstr 8028)
23. Horn L, Spigel DR, Gettinger SN, et al: Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): Update from a phase Ia study. J Clin Oncol 33, 2015 (suppl; abstr 8029)
24. Besse B, Johnson M, Jänne PA, et al: Phase II, single-arm trial (BIRCH) of atezolizumab as first-line or subsequent therapy for locally advanced or metastatic PD-L1-selected non-small cell lung cancer (NSCLC). Presented at European Cancer Congress, Vienna, Austria, September 25-29, 2015 (abstr 16LBA)
25. Frampton GM, Fichtenholtz A, Otto GA, et al: Development and validation of a clinical cancer genomic profiling test based on massively parallel DNA sequencing. Nat Biotechnol 31:1023-1031, 2013
26. Pirker R, Pereira JR, Szczesna A, et al: Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): An open-label randomised phase III trial. Lancet 373:1525-1531, 2009
27. Reck M, von Pawel J, Zatloukal P, et al: Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous nonsmall- cell lung cancer: Results from a randomised phase III trial (AVAiL). Ann Oncol 21:1804-1809, 2010
28. Rittmeyer A, Barlesi F, Waterkamp D, et al: Atezolizumab versus docetaxel in patients withpreviously treated non-small-cell lung cancer (OAK): A phase 3, open-label, multicentre randomised controlled trial. Lancet 389:255-265, 2017
29. Gainor JF, Shaw AT, Sequist LV, et al: EGFR mutations and ALK rearrangements are associated with low response rates to PD-1 pathway blockade in non-small cell lung cancer: A retrospective analysis. Clin Cancer Res 22:4585-4593, 2016
30. Socinski M, Creelan B, Horn L, et al: CheckMate 026: A phase 3 trial of nivolumab vs investigator's choice (IC) of platinum-based doublet chemotherapy (PT-DC) as first-line therapy for stage iv/recurrent programmed death ligand 1 (PD-L1)-positive NSCLC. Ann Oncol 27 (suppl-6):LBA7-PR, 2016 doi:10.1093/annonc/mdw435.39