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)

 

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.