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Atezolizumab vs Docetaxel in Pretreated Patients with Non-Small Cell Lung Cancer: Final Results From the Randomized Phase II POPLAR and Phase III OAK Clinical Trials.

Identifieur interne : 000552 ( Main/Exploration ); précédent : 000551; suivant : 000553

Atezolizumab vs Docetaxel in Pretreated Patients with Non-Small Cell Lung Cancer: Final Results From the Randomized Phase II POPLAR and Phase III OAK Clinical Trials.

Auteurs : Julien Mazieres [France] ; Achim Rittmeyer [Allemagne] ; Shirish Gadgeel [États-Unis] ; Toyoaki Hida [Japon] ; David R. Gandara [États-Unis] ; Diego L. Cortinovis [Italie] ; Fabrice Barlesi ; Wei Yu [États-Unis] ; Christina Matheny [États-Unis] ; Marcus Ballinger [États-Unis] ; Keunchil Park [Corée du Sud]

Source :

RBID : pubmed:33166718

Abstract

INTRODUCTION

The phase II POPLAR and phase III OAK studies of the anti-PD-L1 immunotherapy atezolizumab in patients with previously treated advanced non-small cell lung cancer (NSCLC) showed significant improvements in survival vs docetaxel. Longer follow-up permits evaluation of continued benefit of atezolizumab. This study reports final overall survival (OS) and safety findings from both trials.

METHODS

POPLAR randomized 287 (atezolizumab,144; docetaxel,143) and OAK randomized 1225 (atezolizumab, 613; docetaxel, 612) patients. Patients received atezolizumab (1200-mg fixed dose) or docetaxel (75 mg/m

RESULTS

A longer OS was observed in patients receiving atezolizumab vs docetaxel in POPLAR (median OS: 12.6 months vs 9.7 months; HR: 0.76 [95% CI: 0.58-1.00]) and OAK (median OS: 13.3 vs 9.8 months; HR: 0.78 [95% CI: 0.68-0.89]. Four-year OS rates in POPLAR were 14.8% (8.7-20.8) and 8.1% (3.2-13.0) for atezolizumab and docetaxel, respectively, and 15.5% (12.4-18.7) and 8.7% (6.2-11.3) in OAK. Atezolizumab had improved OS benefit compared with docetaxel across all PD-L1 expression and histology groups. Most 4-year survivors in the docetaxel arms received subsequent immunotherapy (POPLAR, 50%; OAK, 65%). Of 4-year survivors, most had ECOG PS 0 and nonsquamous histology; approximately half were responders (POPLAR: atezolizumab, 7/15; docetaxel, 3/4; OAK: atezolizumab, 24/43; docetaxel, 11/26). Treatment-related Grade 3/4 adverse events occurred in 27% and 16% of atezolizumab 4-year survivors in POPLAR and OAK, respectively.

CONCLUSIONS

Long-term follow-up suggests a consistent survival benefit with atezolizumab vs docetaxel in patients with previously treated NSCLC regardless of PD-L1 expression, histology, or subsequent immunotherapy. Atezolizumab had no new safety signals, and the safety profile was similar to previous studies.

STUDY IDENTIFIERS

NCT01903993, NCT02008227.


DOI: 10.1016/j.jtho.2020.09.022
PubMed: 33166718


Affiliations:


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Le document en format XML

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<p>
<b>INTRODUCTION</b>
</p>
<p>The phase II POPLAR and phase III OAK studies of the anti-PD-L1 immunotherapy atezolizumab in patients with previously treated advanced non-small cell lung cancer (NSCLC) showed significant improvements in survival vs docetaxel. Longer follow-up permits evaluation of continued benefit of atezolizumab. This study reports final overall survival (OS) and safety findings from both trials.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>POPLAR randomized 287 (atezolizumab,144; docetaxel,143) and OAK randomized 1225 (atezolizumab, 613; docetaxel, 612) patients. Patients received atezolizumab (1200-mg fixed dose) or docetaxel (75 mg/m</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>A longer OS was observed in patients receiving atezolizumab vs docetaxel in POPLAR (median OS: 12.6 months vs 9.7 months; HR: 0.76 [95% CI: 0.58-1.00]) and OAK (median OS: 13.3 vs 9.8 months; HR: 0.78 [95% CI: 0.68-0.89]. Four-year OS rates in POPLAR were 14.8% (8.7-20.8) and 8.1% (3.2-13.0) for atezolizumab and docetaxel, respectively, and 15.5% (12.4-18.7) and 8.7% (6.2-11.3) in OAK. Atezolizumab had improved OS benefit compared with docetaxel across all PD-L1 expression and histology groups. Most 4-year survivors in the docetaxel arms received subsequent immunotherapy (POPLAR, 50%; OAK, 65%). Of 4-year survivors, most had ECOG PS 0 and nonsquamous histology; approximately half were responders (POPLAR: atezolizumab, 7/15; docetaxel, 3/4; OAK: atezolizumab, 24/43; docetaxel, 11/26). Treatment-related Grade 3/4 adverse events occurred in 27% and 16% of atezolizumab 4-year survivors in POPLAR and OAK, respectively.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>Long-term follow-up suggests a consistent survival benefit with atezolizumab vs docetaxel in patients with previously treated NSCLC regardless of PD-L1 expression, histology, or subsequent immunotherapy. Atezolizumab had no new safety signals, and the safety profile was similar to previous studies.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>STUDY IDENTIFIERS</b>
</p>
<p>NCT01903993, NCT02008227.</p>
</div>
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<ISSN IssnType="Electronic">1556-1380</ISSN>
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<PubDate>
<Year>2020</Year>
<Month>Nov</Month>
<Day>06</Day>
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<Title>Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer</Title>
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<ArticleTitle>Atezolizumab vs Docetaxel in Pretreated Patients with Non-Small Cell Lung Cancer: Final Results From the Randomized Phase II POPLAR and Phase III OAK Clinical Trials.</ArticleTitle>
<ELocationID EIdType="pii" ValidYN="Y">S1556-0864(20)30802-9</ELocationID>
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<Abstract>
<AbstractText Label="INTRODUCTION" NlmCategory="BACKGROUND">The phase II POPLAR and phase III OAK studies of the anti-PD-L1 immunotherapy atezolizumab in patients with previously treated advanced non-small cell lung cancer (NSCLC) showed significant improvements in survival vs docetaxel. Longer follow-up permits evaluation of continued benefit of atezolizumab. This study reports final overall survival (OS) and safety findings from both trials.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">POPLAR randomized 287 (atezolizumab,144; docetaxel,143) and OAK randomized 1225 (atezolizumab, 613; docetaxel, 612) patients. Patients received atezolizumab (1200-mg fixed dose) or docetaxel (75 mg/m
<sup>2</sup>
) every 3 weeks. Efficacy and safety outcomes were evaluated.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">A longer OS was observed in patients receiving atezolizumab vs docetaxel in POPLAR (median OS: 12.6 months vs 9.7 months; HR: 0.76 [95% CI: 0.58-1.00]) and OAK (median OS: 13.3 vs 9.8 months; HR: 0.78 [95% CI: 0.68-0.89]. Four-year OS rates in POPLAR were 14.8% (8.7-20.8) and 8.1% (3.2-13.0) for atezolizumab and docetaxel, respectively, and 15.5% (12.4-18.7) and 8.7% (6.2-11.3) in OAK. Atezolizumab had improved OS benefit compared with docetaxel across all PD-L1 expression and histology groups. Most 4-year survivors in the docetaxel arms received subsequent immunotherapy (POPLAR, 50%; OAK, 65%). Of 4-year survivors, most had ECOG PS 0 and nonsquamous histology; approximately half were responders (POPLAR: atezolizumab, 7/15; docetaxel, 3/4; OAK: atezolizumab, 24/43; docetaxel, 11/26). Treatment-related Grade 3/4 adverse events occurred in 27% and 16% of atezolizumab 4-year survivors in POPLAR and OAK, respectively.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Long-term follow-up suggests a consistent survival benefit with atezolizumab vs docetaxel in patients with previously treated NSCLC regardless of PD-L1 expression, histology, or subsequent immunotherapy. Atezolizumab had no new safety signals, and the safety profile was similar to previous studies.</AbstractText>
<AbstractText Label="STUDY IDENTIFIERS" NlmCategory="UNASSIGNED">NCT01903993, NCT02008227.</AbstractText>
<CopyrightInformation>Copyright © 2020. Published by Elsevier Inc.</CopyrightInformation>
</Abstract>
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<LastName>Mazieres</LastName>
<ForeName>Julien</ForeName>
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<Affiliation>Toulouse University Hospital, Institut Universitaire du Cancer de Toulouse, Université Paul Sabatier, Toulouse, France; Address: Toulouse University Hospital, Larrey Hospital, Chemin de Pouvourville, 314àà Toulouse, France. Electronic address: mazieres.j@chu-toulouse.fr.</Affiliation>
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<Affiliation>UC Davis Comprehensive Cancer Center, Sacramento, CA, USA; Address: UC Davis Comprehensive Cancer Center, 4501 X St, Sacramento, CA 95817.</Affiliation>
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<Affiliation>Aix-Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France; Address: Hôpital Nord - Chemin des Bourrelly - 13915 Marseille Cedex 20.</Affiliation>
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<Initials>C</Initials>
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<Affiliation>Genentech, Inc., South San Francisco, CA, USA; Address: Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080.</Affiliation>
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<Affiliation>Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; Address: Samsung Medical Center, 81 Irwon-ro, Gananam-gu, Seoul, 06351, Korea.</Affiliation>
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<Keyword MajorTopicYN="N">atezolizumab</Keyword>
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