Background

Atezo treatment (tx) has demonstrated improved survival and a manageable safety in advanced NSCLC. TAIL (NCT03285763) is a phase III/IV study evaluating the safety and efficacy of atezo in patients (pts) with previously treated advanced NSCLC, including those who are generally excluded from pivotal trials.

Methods

TAIL enrolled pts with Stage IIIb/IV NSCLC who experienced disease progression after 1-2 lines of standard chemotherapy. Eligible subgroups included prior anti–PD-1 therapy, ECOG PS 2, renal impairment and pre-existing autoimmune disease. Atezo was given at 1200 mg IV q3w. The primary endpoint is safety as measured by the incidences of treatment-related (TR) serious AEs (SAEs) and TR immune-related AEs (irAEs). Secondary endpoints are OS and PFS, ORR and duration of response (DOR) per investigator assessment.

Results

Of the 619 pts enrolled between Oct 2017 and Dec 2018, 615 received atezo. Median age was 64 y, 60% of pts were male and 90% had ECOG PS 0/1. At data cutoff (4 Jun 2019), median follow-up was 12.7 mo (95% CI 11.9, 13.1); 133 pts (21.5%) remained on tx and 316 pts (51.1%) had died. Co-primary endpoints: TR SAEs occurred in 7.8% of pts and TR irAEs occurred in 8.3% (Table). Median OS was 11.1 mo (95% CI 8.9, 12.9), ORR was 11.1% (95% CI 8.7, 13.8) and median DOR was 14.6 mo (95% CI 8.4, 15.4). In a subgroup of pts similar to those in the phase III OAK study (n = 406), mOS was 13.7 mo (95% CI 11.6, 15.5), ORR was 13.6% (95% CI 10.4, 17.3) and mDOR was 14.6 mo (95% CI 7.7, NE). Safety and efficacy data in subgroups, including PD-L1 expression, prior anti–PD-1 therapy, ECOG PS 2, renal impairment and autoimmune disease will be presented.Table:

LBA84

Conclusions

TAIL confirmed the safety profile of atezo monotherapy in a diverse, previously treated NSCLC population. The safety and efficacy data may inform treatment decisions for pts generally excluded from pivotal trials.

Clinical trial identification

NCT03285763.

Editorial acknowledgement

Medical writing assistance for this abstract was provided by Kia C. E. Walcott, 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

A. Ardizzoni: Honoraria (self): Eli-Lilly; Honoraria (self): Pfizer; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy: MSD; Advisory / Consultancy, Research grant / Funding (institution): Roche; Advisory / Consultancy: AstraZeneca; Research grant / Funding (institution): Celgene. S. Azevedo: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Roche; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (self), Research grant / Funding (institution): Lilly; Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: MSD. D. Rodriguez Abreu: Full / Part-time employment: Insular University Hospital in Gran Canaria, Spain; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD; Advisory / Consultancy, Speaker Bureau / Expert testimony: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca. J. Alatorre-Alexander: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Merck-Sharp & Domme; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Leadership role: Head of Oncology in National Institute of Respiratory Diseases Mexico ; Full / Part-time employment: Medical oncologist National Institute of Respiratory Diseases. H.J. Smit: Advisory / Consultancy: MSD; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: BMS; Leadership role: Secretary section oncology NVALT (Dutch lung phycisions organasation); Leadership role: president DLCA (Dutch Lung Cancer Audit). K. Syrigos: Speaker Bureau / Expert testimony: MSD; Research grant / Funding (institution): ROCHE; Research grant / Funding (institution): NOVARTIS; Research grant / Funding (institution), Travel / Accommodation / Expenses: BMS; Travel / Accommodation / Expenses: GENESIS. H. Patel: Full / Part-time employment: Genentech/Roche. J. Tolson: Full / Part-time employment: Roche. A. Cardona: Honoraria (institution), Full / Part-time employment: F. Hoffmann-La Roche . P. Perez Moreno: Full / Part-time employment: Roche/Genentech. T. Newsom-Davis: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZenca,; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS,; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Boehringer Ingelheim; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Eli Lilly,; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: MSD,; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Otsuka,; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche,; Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Takeda; Advisory / Consultancy: Amgen,; Advisory / Consultancy: Pfizer,; Leadership role: Vice-Chair, British Thoracic Oncology Group. All other authors have declared no conflicts of interest.