429TiP - IMpower010: A Phase III trial investigating atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy (chemo) in patients (pts...

Date 18 December 2016
Event ESMO Asia 2016 Congress
Session Poster lunch
Topics Non-Small Cell Lung Cancer
Immunotherapy
Presenter Caicun Zhou
Citation Annals of Oncology (2016) 27 (suppl_9): ix134-ix135. 10.1093/annonc/mdw592
Authors C. Zhou1, N. Altorki2, E. Valliéres3, E. Felip4, Y. Zuo5, M. Howland6, F. Xia5, T. Hoang6, A. Sandler7, H. Wakelee8
  • 1Department Of Oncology, Shanghai Pulmonary Hospital, Tongji University, 200433 - Shanghai/CN
  • 2N/a, New York-Presbyterian Hospital, Weill Cornell Medicine, New York/US
  • 3N/a, Swedish Cancer Institute, Seattle/US
  • 4Medical Oncology, Vall d’Hebron University Hospital, Barcelona/ES
  • 5N/a, Roche (China) Holding Ltd, Shanghai/CN
  • 6N/a, Genentech, Inc., 94080 - South San Francisco/US
  • 7Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 8Department Of Medicine, Division Of Oncology, Stanford University School of Medicine, Stanford/US

Abstract

Background

Atezo, an anti–PD-L1 mAb, prevents the binding of PD-L1 to PD-1 and B7.1 and restores antitumor immune response. Single-agent atezo has promising efficacy and tolerability in pts with previously treated advanced NSCLC, with a survival benefit observed across PD-L1 expression levels. Given the need to improve survival of pts with early-stage NSCLC, IMpower010 (NCT02486718) has been initiated. This global Phase III, randomized, open-label trial will evaluate the efficacy and safety of atezo vs BSC, following adjuvant cisplatin (cis)-based chemo in pts with resected stage IB (tumors ≥ 4 cm)-IIIA NSCLC.

Trial design

Eligibility criteria include complete tumor resection 4-12 weeks prior to enrollment for pathologic stage IB (tumors ≥ 4 cm)-IIIA NSCLC. Pts must have adequately recovered from surgery, be eligible to receive cis-based adjuvant chemo and have an ECOG PS 0-1. Exclusion criteria include the presence of other malignancies, use of hormonal cancer or radiation therapy within 5 years, prior chemo, exposure to prior immunotherapy and autoimmune disease. Approximately 1127 pts will be enrolled regardless of PD-L1 expression status. Suitable pts will receive up to four 21-d cycles of cis-based chemo (cis [75 mg/m2 IV, d 1] + either vinorelbine [30 mg/m2 IV, d 1, 8], docetaxel [75 mg/m2 IV, d 1] or gemcitabine [1250 mg/m2 IV, d 1, 8], or pemetrexed [500 mg/m2 IV, d 1; nonsquamous NSCLC only]). Adjuvant radiation therapy is not permitted. After adjuvant treatment, eligible pts will be randomized 1:1 to receive atezo 1200 mg q3w, 16 cycles or BSC. Stratification factors include sex, histology (squamous vs nonsquamous), extent of disease (stage IB vs II vs IIIA) and PD-L1 expression by IHC (tumor cell [TC]; tumor-infiltrating immune cell [IC]; TC2/3 [≥ 5% expressing PD-L1] and any IC vs TC0/1 [< 5%] and IC2/3 vs TC0/1 and IC0/1 [< 5%]). The primary endpoint is disease-free survival; secondary endpoints include OS and safety. Exploratory endpoints include PD-L1 status, immune- and tumor-related biomarkers before, during and after treatment with atezo and at radiographic disease recurrence, or confirmation of new primary NSCLC.

Clinical trial indentification

NCT02486718

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd

Funding

F. Hoffmann-La Roche Ltd

Disclosure

C. Zhou: lecture fee from AZ, Roche, Eli Lily, Pfizer, Sanofi. E. Felip: Honoraria: Boeheringer Ingelheim, MSD, Eli Lilly, Roche, Pfizer, Novartis, BMS, Celgene Consulting or advisory role: Boeheringer Ingelheim, MSD, Eli Lilly, Roche, Pfizer, Novartis, BMS, Celgene Speakers\' Bureau: BMS, Novartis, Roche. Y. Zuo: Roche employee, Roche research funding. M. Howland, F. Xia: Roche employee. T. Hoang, A. Sandler: Genentech employee. H. Wakelee: Research/grant: Clovis, Exelixis, AstraZeneca/Medimmune, Genentech/Roche, BMS, Gilead, Novartis, Xcovery, Pfizer, Celgene, Pharmacyclics, Lilly. Consulting: Peregrine, Acea, Pfizer, Helsinn, Genentech(uncompensated). All other authors have declared no conflicts of interest.