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Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC

Date

09 Oct 2016

Session

Presidential Symposium 2

Presenters

Fabrice Barlesi

Citation

Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435

Authors

F. Barlesi1, K. Park2, F. Ciardiello3, J. von Pawel4, S. Gadgeel5, T. Hida6, D. Kowalski7, M.C. Dols8, D. Cortinovis9, J. Leach10, J. Polikoff11, D. Gandara12, C.H. Barrios13, D.S. Chen14, P. He15, M. Kowanetz16, M. Ballinger17, D. Waterkamp14, A. Sandler14, A. Rittmeyer18

Author affiliations

  • 1 Assistance Publique Hôpitaux De Marseille, Aix Marseille University, 13915 - Marseille/FR
  • 2 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul/KR
  • 3 Medical Oncology, AOU Seconda Università degli Studi di Napoli (AOU-SUN), 81130 - Napoli/IT
  • 4 Oncology, Asklepios-Fachklinikum, 82131 - Gauting/DE
  • 5 Wayne State University, Karmanos Cancer Institute, Detroit/US
  • 6 Aichi Cancer Center Hospital, Nagoya, Japan, Aichi Cancer Center Hospital, Nagoya, Japan, Nagoya/JP
  • 7 Department Of Lung Cancer And Chest Tumours, The Maria Sklodowska-Curie Institute of Oncology, Warsaw/PL
  • 8 Medical Oncology Section, Hospital Universitario Málaga General Carlos Haya, Malaga/ES
  • 9 Dept. Of Medical Oncology, Azienda Ospedaliera San Gerardo Hospital, 20900 - Monza/IT
  • 10 Medical Oncology, Metro-Minnesota Community Oncology Research Consortium, Minneapolis/US
  • 11 Oncology, Southern California Permanente Medical Group, San Diego/US
  • 12 Internal Medicine, University of California Davis Cancer Center, 95817 - Sacramento/US
  • 13 Department Of Medicine, Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre/BR
  • 14 Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 15 Biostatistics, Genentech, Inc., South San Francisco/US
  • 16 Oncology Biomarker Development, Genentech, Inc., 94080 - South San Francisco/US
  • 17 Product Development, Oncology, Genentech, Inc., South San Francisco/US
  • 18 Oncology, Lungenfachklinik Immenhausen, Immenhausen/DE
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Background

Atezolizumab (atezo) inhibits the binding of PD-L1 to its receptors PD-1 and B7.1, thereby restoring tumor-specific T-cell immunity, while leaving the PD-L2/PD-1 interaction intact. Atezo demonstrated survival benefit vs docetaxel (doc) in the Ph2 trial POPLAR. Here we present the primary analysis from the Ph3 OAK study evaluating atezo vs doc in previously treated NSCLC.

Methods

Previously treated NSCLC patients (pts) were stratified by PD-L1 status, prior chemotherapy regimens (1 vs 2) and histology, and randomized 1:1 to atezo (1200 mg IV q3w) or doc (75 mg/m2 IV q3w). The co-primary endpoints were OS in the ITT and PD-L1–expression subgroup TC1/2/3 or IC1/2/3 (PD-L1 expression on ≥ 1% TC or IC). Secondary endpoints included PFS, ORR, DoR and safety.

Results

The primary efficacy analysis was conducted in the first 850 of 1225 total enrolled pts. Pts had a median age of 64 y, 61% were male, 25% had 2 prior lines of therapies, 26% had squamous histology, 67% were previous smokers and 37% were PS 0. Superior OS was seen with atezo vs doc in ITT (HR 0.73; P = .0003) and TC1/2/3 or IC1/2/3 pts (HR 0.74; P = .0102). Survival was improved regardless of PD-L1 expression levels, including in pts with no PD-L1 expression (TC0 and IC0). There was pronounced benefit in pts with high PD-L1 expression (TC3 or IC3). OS benefit was similar in pts with squamous or nonsquamous histology. In ITT pts, PFS HR was 0.95 (2.8 vs 4.0 mo), ORR 13.6% vs 13.4%, and DoR 16.3 vs 6.2 mo for atezo vs doc. Gr 3-4 treatment-related AEs occurred in 15% of atezo pts and 43% of doc pts. There were no deaths related to atezo and 1 related to doc. No new safety signal was observed.

Conclusions

This first Ph3 trial of a PD-L1-directed drug in NSCLC demonstrates that atezo treatment results in a statistically significant and clinically relevant improvement in OS vs doc in 2L/3L NSCLC, regardless of PD-L1 expression and histology. Atezo was well tolerated with a favorable safety profile vs doc.

Clinical trial identification

NCT02008227

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd

Funding

F. Hoffmann-La Roche Ltd

Disclosure

K. Park: Consultant: Astellas, Astra-Zeneca, Aveo, Boehringer Ingelheim, Clovis, Eli Lilly, Hanmi, KHK Novartis, Ono, Roche Research funding: Astra-Zeneca. F. Ciardiello: Advisory boards: Merck Serono, AstraZeneca, Lilly, Roche, Bayer. J. von Pawel: Consultant/Advisory (compensated) role for Paischi, Pfizer, Vertex, Cloves. S. Gadgeel: Served on Advisory Boards and was compensated by the following pharmaceutical companies- Roche/Genentech, Pfizer, BMS, Ariad, Boehringer-Ingelheim, Astra-Zeneca. Speaker's Bureau- Astra-Zeneca. T. Hida: Corporate-sponsored research: Chugai Pharmaceutical. D. Gandara: Grant and consultant: Genentech, BMS, MERCK and EMD Serrano. C.H. Barrios: Research/Consulting: Pfizer, Novartis, Amgen, AstraZeneca, BI, GSK, Roche, Lilly, Sanofi, Taiho, Mylan, Merrimack, Merck, Abbvie, Astellas, Biomarin, BMS, Daiichi Sankyo, Abraxis, ABS, Asana, Medivation, Exelixis, ImClone, LEO, Millennium, Eisai, Bioepis. D.S. Chen: Genentech employee, Genentech Roche stock. P. He: Genentech employee, Roche and Amgen stocks. M. Kowanetz: Employee of Genentech + Genentech stock. M. Ballinger: Genentech employee; Stocks: Roche, Exelixis, Sunesis. D. Waterkamp: Genentech employee, Roche stock. A. Sandler: Genentech employee, Compensated Consultant role for Genentech/Roche, Genentech/Roche stock, Honoraria recipient from Genentech/Roche, Genentech research funding paid to institution, Provided compensated expert testimony for Genentech/Roche. A. Rittmeyer: Consulting or advisory role for Roche, Lilly, BMS, Boehing. Grants: Roche, Lilly, BMS, AstraZeneca, MSD, Boehringer Ingelheim, Pfizer. All other authors have declared no conflicts of interest.

OS
Atezo Doc HRa (95% CI) P Value
n Median, mo n Median, mo
ITT 425 13.8 425 9.6 0.73 (0.62, 0.87) 0.0003b
TC1/2/3 or IC1/2/3 241 15.7 222 10.3 0.74 (0.58, 0.93) 0.0102b
TC2/3 or IC2/3 129 16.3 136 10.8 0.67 (0.49, 0.90) 0.0080
TC3 or IC3 72 20.5 65 8.9 0.41 (0.27, 0.64)

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Session: Presidential Symposium 2

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Presentation

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