Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

NSCLC, metastatic 1

2150 - Clinical Efficacy of Atezolizumab (Atezo) in PD-L1 Subgroups Defined by SP142 and 22C3 IHC Assays in 2L+ NSCLC: Results From the Randomized OAK Study

Date

08 Sep 2017

Session

NSCLC, metastatic 1

Topics

Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Non-Small Cell Lung Cancer

Presenters

Shirish Gadgeel

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

S. Gadgeel1, M. Kowanetz2, W. Zou3, F.R. Hirsch4, K.M. Kerr5, D.R. Gandara6, F. Barlesi7, K. Park8, M. McCleland2, H. Koeppen9, M. Ballinger10, A. Sandler10, P.S. Hegde2, A. Rittmeyer11

Author affiliations

  • 1 Medical Oncoloy, University of Michigan, 48109-5942 - Ann Arbor/US
  • 2 Oncology Biomarker Development, Genentech, South San Francisco/US
  • 3 Biostatistics, Genentech, South San Francisco/US
  • 4 Division Of Medical Oncology, University of Colorado Anschutz Medical Campus, Aurora/US
  • 5 Pathology, Aberdeen Royal Infirmary/ Aberdeen University Medical School, AB25 2ZN - Aberdeen/GB
  • 6 Thoracic Oncology, UC Davis Comprehensive Cancer Center, Sacramento/US
  • 7 Multidisciplinary Oncology & Therapeutic Innovations, Aix Marseille University, Marseille/FR
  • 8 Division Of Heamatology/oncology, Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 9 Research Pathology, Genentech, South San Francisco/US
  • 10 Product Development Oncology, Genentech, South San Francisco/US
  • 11 Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen/DE
More

Resources

Abstract 2150

Background

In the Phase III OAK trial, patients (pts) with previously treated advanced NSCLC had improved median overall survival (OS) with atezo vs docetaxel (doc), regardless of PD-L1 expression (per VENTANA PD-L1 SP142 IHC assay). Although efficacy correlated with PD-L1 expression on tumor cells (TC) and tumor-infiltrating immune cells (IC), an OS benefit was also observed in pts with PD-L1–negative tumors (i.e., TC0 and IC0; HR, 0.75 [95% CI: 0.59, 0.96]). To determine whether these results were consistent across PD-L1 IHC assays, we assessed atezo efficacy in PD-L1 subgroups as defined by SP142 and Dako 22C3 pharmDx PD-L1 IHC assays.

Methods

PD-L1 expression was assessed prospectively with SP142 and retrospectively with 22C3. The SP142 assay measured PD-L1 expression on TC and IC, while the 22C3 assay gave a tumor proportion score (TPS) based on TC membrane staining.

Results

Among the primary population of 850 pts (ITT850), 400 had results from the 22C3 assay (biomarker-evaluable population [BEP]). Clinical outcomes in the BEP vs ITT850, and prevalence in PD-L1 subgroups are summarized (Table). Among pts with tumors negative by SP142 (TC0 and IC0), most (77%) were also negative by 22C3 (TPS < 1%). Comparable OS benefit with atezo was seen in PD-L1–negative subgroups defined by both assays. Improved clinical benefit was observed in pts with the highest PD-L1 expression by either assay (TC3 or IC3 by SP142, or TPS ≥ 50% by 22C3; Table).

Conclusions

Prevalence of PD-L1 subgroups in the BEP was consistent with previous reports for both assays. Most tumors considered negative by SP142 were also negative by 22C3. An OS benefit (atezo vs doc) was observed in PD-L1–negative subgroups defined by either assay and was consistent with the overall population results from OAK. These data provide evidence of atezo OS benefit in pts with PD-L1–negative tumors irrespective of the PD-L1 IHC assay used.Table:

1296O

Clinical efficacy in OAK ITT850 and BEP populations
ITT850 (N = 850)BEP (N = 400)
OS HR (atezo vs doc) (95% CI)0.73 (0.62, 0.87)0.56 (0.44, 0.71)
PFS HR (atezo vs doc) (95% CI)0.95 (0.82, 1.10)0.75 (0.61, 0.93)
Prevalence of PD-L1 subgroups in OAK BEP (n = 400)
SP14222C3
PD-L1 negative TC0 and IC0, or TPS < 1%38%55%
PD-L1 positive TC1/2/3 or IC1/2/3, or TPS ≥ 1%62%46%
PD-L1 high TC3 or IC3, or TPS ≥ 50%18%25%
OS HR (atezo vs doc) in PD-L1 subgroups in OAK BEP (n = 400) (95% CI)
SP14222C3
PD-L1 negative0.550.61
TC0 and IC0, or TPS < 1%(0.37, 0.80)(0.45, 0.84)
PD-L1 positive0.580.51
TC1/2/3 or IC1/2/3, or TPS ≥ 1%(0.42, 0.78)(0.36, 0.73)
PD-L1 high0.370.49
TC3 or IC3, or TPS ≥ 50%(0.20, 0.66)(0.29, 0.80)

Clinical trial identification

NCT02008227

Legal entity responsible for the study

F. Hoffmann - La Roche Ltd.

Funding

F. Hoffmann - La Roche Ltd.

Disclosure

S. Gadgeel: Speaker\'s bureau‐ Astra‐Zeneca, Genentech/Roche Advisory Boards‐ Astra‐Zeneca, Ariad, Pfizer, Bristol Myers‐ Squibb and Genentech/Roche. M. Kowanetz: Genentech employee and Roche stock. W. Zou: Genentech employee, Roche research funding. F.R. Hirsch: Scientific Advisory Boards: Genentech/Roche, AstraZeneca, Lilly, BMS HTG Research Grant (through University of Colorado): Bayer, BMS, Genentech/Roche. K.M. Kerr: Lecture honoraria and/or consultancy fees from Roche, AZ, BI, Lilly, Pfizer, Merck Serono, MSD, BMS. D.R. Gandara: Consultant: Genentech Clinical trial grant: Genentech. F. Barlesi: Honorarium from Roche. K. Park: Consulting/Advisory Role: Astellas Pharma, AstraZeneca, Boehringer Ingelheim, Clovis Oncology, Lilly, Hanmi, Kyowa Hakko Kirin, Novartis, Ono Pharmaceutical, Roche Speakers Bureau: Boehringer Ingelheim Research Funding: AstraZeneca. M. McCleland, P.S. Hegde, H. Koeppen: Genentech employee. M. Ballinger, A. Sandler: Employee of Genentech, Roche stock. A. Rittmeyer: Grants as an advisor or speaker by: Astra Zeneca, BMS, Boehringer Ingelheim, Eli Lilly, Pfizer and Roche Genentech.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.