375O - Final efficacy results from IMpower132: First-line atezolizumab + chemotherapy in patients with stage IV non-squamous NSCLC

Background

The Phase III IMpower132 study, evaluating first line pemetrexed plus carboplatin/cisplatin with or without atezolizumab in Stage IV non-squamous NSCLC without EGFR or ALK driver mutations, has met its PFS endpoint with an HR of 0.60 (95% CI: 0.49, 0.72; P < 0.0001; Papadimitrakopoulou, WCLC 2018). Here we present the final OS and safety results.

Methods

Patients were randomised 1:1 to 4 or 6 cycles of carboplatin AUC 6 mg/mL/min or cisplatin 75 mg/m² + pemetrexed 500 mg/m² Q3W alone (arm PP) or with atezolizumab 1200 mg Q3W (arm APP), followed by pemetrexed (PP) or atezolizumab + pemetrexed (APP) maintenance. Investigator-assessed PFS and OS were co-primary endpoints. Efficacy by PD-L1 status was an exploratory endpoint.

Results

At data cutoff (18 July 2019), 292 patients in arm APP and 286 patients in arm PP had a median follow-up of 28.4 mo. Updated median PFS was 7.7 months (APP) vs 5.2 months (PP); HR, 0.56 (95% CI: 0.47, 0.67). Final OS data are in the table. 38.7% (APP) vs 57.3% (PP) of patients received subsequent anti-cancer therapy, including immunotherapy in 5.5% vs 45.8%. Grade ≥ 3 treatment-related adverse events (AEs) occurred in 58.4% (APP) vs 43.1% (PP) of patients, including immune-mediated AEs in 6.9% (APP) vs 4.7% (PP) of patients. Table: 375O

NE, not estimable. ^a Stratified. ^b PD-L1 status available in 60% of pts. PD-L1–high: ≥ 50% TC or ≥ 10% IC; PD-L1–low: ≥ 1% and < 50% TC or ≥ 1% and < 10% IC; PD-L1–negative: < 1% TC and < 1% IC.

Conclusions

IMpower132 had met its co-primary PFS endpoint at the primary analysis but did not meet its co-primary OS endpoint in this final analysis. Atezolizumab + carboplatin/cisplatin + pemetrexed was well tolerated, and no new safety signals were identified.

Clinical trial identification

NCT02657434.

Editorial acknowledgement

Medical writing assistance for this abstract was provided by Chris Lum, PhD of Health Interactions and by Kshipra Desai, PhD of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.

Funding

F. Hoffmann-La Roche, Ltd.

Disclosure

M. Nishio: Speaker Bureau/Expert testimony, Research grant/Funding (institution), Grants and Perosnal Fees: Ono Pharmaceutical; BMS; Pfizer; Chugai Pharmaceutical; Eli Lilly; Taiho Pharmaceutical; AstraZeneca; Boehringer-Ingelheim; MSD; Novartis; Speaker Bureau/Expert testimony, Research grant/Funding (institution), Personal Fees: Sankyo Healthcare; Research grant/Funding (institution), Personal Fees: Merck Serono; Research grant/Funding (institution), Grants: Astellas. F. Barlesi: Honoraria (self), Personal Financial Interest, Institutional Financial Interest, Non-Financial Interest: AstraZeneca; BMS; Merck; Pierre Fabre; Roche; Honoraria (self), Personal Financial Interest, Institutional Financial Interest: Bayer; Boehringer-Ingelheim; Eli Lilly Oncology; Novartis; MSD; Pfizer; Takeda; Honoraria (self), Institutional Financial Interest: AbbVie; ACEA; Amgen; Eisai; Genentech; Ipsen; Ignyta; Innate Pharma; Loxo; MedImmune; Sanofi-Aventis. R. Bordoni: Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Merck; Speaker Bureau/Expert testimony: Genentech; Speaker Bureau/Expert testimony: Guardant Health. J. Goldschmidt: Advisory/Consultancy: Amgen; Speaker Bureau/Expert testimony: Bristol-Myers Squibb. S. Novello: Speaker Bureau/Expert testimony: AstraZeneca; Speaker Bureau/Expert testimony: Boehringer-Ingelheim; Speaker Bureau/Expert testimony: Eli Lilly; Speaker Bureau/Expert testimony: Roche; Speaker Bureau/Expert testimony: Takeda; Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: BMS. F.J. Orlandi: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (self): AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution): Merck & Co.; Research grant/Funding (institution): Amgen; Research grant/Funding (institution): Celltrion; Advisory/Consultancy: Bristol-Myers Squibb; Research grant/Funding (institution), Non-remunerated activity/ies: Novartis; Research grant/Funding (institution): MabXience; Research grant/Funding (institution): Sanofi. R. Sanborn: Honoraria (self), Advisory/Consultancy, Research grant/Funding (self), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): Amgen; Advisory/Consultancy: Seattle; Advisory/Consultancy: Genentech/Roche; Advisory/Consultancy: Celldex; Research grant/Funding (self): Merck; Research grant/Funding (institution): Bristol-Myers Squibb; Research grant/Funding (institution): MedImmune. Z. Szalai: Advisory/Consultancy, Speaker Bureau/Expert testimony: Boehringer-Ingelheim; Bristol-Myers Squibb; Roche; Pfizer; AstraZeneca; Chiesi; MSD. D. Mendus, L. Wang, X. Wen: Full/Part-time employment: Genentech, Inc. M. McCleland: Full/Part-time employment: Genentech, Inc.; Shareholder/Stockholder/Stock options: Roche. T. Hoang: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech/Roche. S. Phan: Full/Part-time employment: Genentech, Inc.; Shareholder/Stockholder/Stock options: Roche. M. Socinski: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Genentech, Inc.; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): AstraZeneca; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Guardant; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Research grant/Funding (institution): Novartis. All other authors have declared no conflicts of interest.