Pneumologie 2017; 71(S 01): S1-S125
DOI: 10.1055/s-0037-1598277
Freie Vorträge – Sektion Pneumologische Onkologie
Lungenkarzinom – Bernd Schmidt/Berlin, Sylvia Gütz/Leipzig
Georg Thieme Verlag KG Stuttgart · New York

Atezolizumab as first-line therapy (1L) for advanced PD-L1-selected NSCLC patients: updated ORR, PFS, OS and exploratory biomarker results from the BIRCH study

W Eberhardt
1   Universitätsklinikum Essen, Ruhrlandklinik, West German Cancer Center, Universität Duisburg-Essen
,
MC Garassino
2   Fondazione Irccs Istituto Nazionale Dei Tumori, Thoracic Oncology Unit
,
NA Rizvi
3   New York-Presbyterian/Columbia University Medical Center
,
B Besse
4   Gustave Roussy, Villejuif France and Paris Sud University
,
PA Jänne
5   Dana-Farber Cancer Institute
,
S Peters
6   Hfr Fribourg-Hôpital Cantonal
,
C Keong Toh
7   National Cancer Centre
,
T Kurata
8   Kansai Medical University Hirakata Hospital
,
E Carcereny Costa
9   Catalan Institute of Oncology Badalona – Germans Trias I Pujol Hospital Badalona
,
M Koczywas
10   City of Hope Medical Center
,
E Felip Font
11   Vall D'hebron Institute of Oncology
,
J Chaft
12   Memorial Sloan Kettering Cancer Center
,
J Qiu
13   Genentech Inc.
,
M Kowanetz
13   Genentech Inc.
,
W Zou
13   Genentech Inc.
,
S Coleman
13   Genentech Inc.
,
S Mocci
13   Genentech Inc.
,
A Sandler
13   Genentech Inc.
,
S Gettinger
14   Yale Cancer Center
,
ML Johnson
15   Sarah Cannon Research Institute
› Author Affiliations
Further Information

Publication History

Publication Date:
23 February 2017 (online)

Also available at
 
 

    Background:

    Atezolizumab (atezo; MPDL3280A) is a humanized mAb that targets PD-L1, inhibiting interactions with PD-1 and B7.1. BIRCH (NCT02031458) is a single-arm Ph II study of atezo monotherapy in PD-L1-selected pts with advanced NSCLC, across different lines of therapy. Primary analyses (median follow-up of 8.5 mo) demonstrated a meaningful ORR benefit in chemo-naive 1L and 2L+ NSCLC pts. Here updated efficacy and exploratory biomarker data in 1L pts from BIRCH are reported.

    Methods:

    Eligibility criteria included PD-L1-selected, advanced-stage NSCLC with no active CNS metastases and no prior chemotherapy (1L). PD-L1 was centrally evaluated with the VENTANA SP142 IHC assay. Pts expressing PD-L1 on ≥5% of tumor cells (TC) or tumor-infiltrating immune cells (IC), ie, TC2/3 or IC2/3, were enrolled. Pts received atezo 1200 mg IV q3w until radiographic disease progression or unacceptable toxicity. The primary endpoint was independent review facility-assessed ORR. Key secondary endpoints, including investigator (INV)-assessed ORR, DOR, PFS (RECIST v1.1) and OS, are reported here.

    Results:

    With a median follow-up of 14.6 mo, INV-assessed ORR was 32% in TC3 or IC3 pts and 24% in TC2/3 or IC2/3 pts. Other clinical benefits, measured by DOR, PFS and OS, were also observed in both PD-L1 groups (Table). No new safety signals were observed. Exploratory biomarker analyses, including efficacy in pts with EGFR or KRAS mutations, will be presented.

    TC3 or IC3

    n = 65

    TC2/3 or IC2/3

    n = 139

    INV ORRa, n (%),

    95% CI

    21 (32%)

    (21.2, 45.1)

    33 (24%)

    (16.9, 31.7)

    Median DORa (mo), 95% CI

    13.1 (8.5, NE)

    13.1 (9.9. 17.5)

    Median OS (mo), 95% CI

    NE

    (12.0, NE)

    20.1

    (20.1, NE)

    12-mo OS rate,

    95% CI

    61%

    (48.8, 73.8)

    66%

    (57.9, 74.5)

    Median PFSa (mo),

    95% CI

    7.3

    (4.9, 12.0)

    7.3 (5.6, 9.1)

    12-mo PFS rate,

    95% CI

    36%

    (23.8, 48.8)

    32%

    (24.0, 40.7)

    NE, not estimable.

    aORR/DOR/PFS assessed by investigator per RECIST v1.1.

    Conclusions:

    With longer follow-up, atezo monotherapy continues to demonstrate promising efficacy across a spectrum of endpoints including OS (mOS 20.1 mo in TC2/3 or IC2/3 1L pts). These data support ongoing 1L Ph III trials assessing atezo monotherapy vs. chemotherapy in PD-L1-selected pts.


    #

    No conflict of interest has been declared by the author(s).