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Poster Display session

9P - Final results from TAIL: Updated long-term safety and efficacy of atezolizumab (atezo) in a diverse population of patients (pts) with previously treated advanced NSCLC


03 Apr 2022


Poster Display session


Tumour Site

Non-Small Cell Lung Cancer


Andrea Ardizzoni


Annals of Oncology (2022) 33 (suppl_2): S27-S70. 10.1016/annonc/annonc856


A. Ardizzoni1, S. Azevedo2, B. Rubio-Viqueira3, D. Rodriguez-Abreu4, J. Alatorre-Alexander5, H.J.M. Smit6, J. Yu7, K. Syrigos8, E. Hoglander9, M. Kaul10, J. Tolson9, Y. Hu9, H.K. Vollan9, T. Newsom-Davis11

Author affiliations

  • 1 Division of Medical Oncology, IRCCS Azienda Ospedaliero—Universitaria di Bologna, 40126 - Bologna/IT
  • 2 Oncology Service, Hospital de Clínicas de Porto Alegre, Porto Alegre/BR
  • 3 Hospital Universitario Quirónsalud Madrid, 28223 - Madrid/ES
  • 4 Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas de Gran Canaria/ES
  • 5 Health Pharma Professional Research, Mexico City/MX
  • 6 Rijnstate Hospital, Arnhem/NL
  • 7 Shandong Cancer Hospital, affiliated to Shandong University, Jinan, Shandong/CN
  • 8 National and Kapodistrian University of Athens, 11527 - Athens, Attica/GR
  • 9 F. Hoffmann-La Roche, Ltd, Basel/CH
  • 10 Genentech, Inc., South San Francisco/US
  • 11 Chelsea and Westminster Hospital, London/GB

Abstract 9P


In the pivotal OAK study (NCT02008227), atezo (anti–PD-L1) significantly improved OS vs docetaxel in previously treated NSCLC. The phase III/IV TAIL study (NCT03285763) evaluated the safety and efficacy of atezo in pts with previously treated advanced NSCLC, including those generally excluded from key clinical trials. At the primary analysis, the co-primary endpoints, treatment-related (TR) serious adverse events (SAEs) and TR immune-related adverse events (irAEs), occurred in 7.8% and 8.3% of pts, respectively. No new safety signals were seen. Here we report final safety and efficacy data from TAIL.


Pts with advanced NSCLC who progressed after 1-2 lines of chemotherapy were enrolled. Pts received 1200 mg of atezo IV once every 3 weeks. Coprimary endpoints were TR SAEs and TR irAEs. Key secondary endpoints included OS, PFS, ORR and DOR. Safety and efficacy in key pt subgroups were also assessed.


Of 619 enrolled pts, 615 received atezo. Median age was 64 y, 60% of pts were male and 90% had ECOG PS 0/1. At data cutoff (26 June 2021), median follow-up was 36.1 mo (range, 0.0-42.3) and 473 pts (77%) had died. TR SAEs and TR irAEs (95% CI) occurred in 8.0% (6, 10) and 9.4% (7, 12) of pts, respectively. The most common Grade ≥3 TR SAEs were pneumonitis (1.0%; including 1 Grade 5 event), pericarditis and colitis (both 0.5%). Safety data for the subgroups were similar to those for the overall population; despite a moderately higher incidence of TR SAEs in the ECOG PS 2 subgroup (13.1%; n=8/61) vs the overall population, the incidence of irAEs was similar (8.2%). Efficacy data are shown in the table.


With a median follow-up of ≈3 y, no new or unexpected safety signals were seen. These updated data confirm a positive risk-benefit ratio for atezo in the prior-treated NSCLC setting and may prove useful for informing tx decisions in pts generally excluded from pivotal NSCLC trials. Table: 9P

Population n ORR, % mDOR, mo mOS, mo 36-mo OS rate, %
All patients 615 11.5 16.6 11.2 19.6
OAK-like 424 14.4 14.7 14.4 25.4
Age ≥ 75 y 76 13.2 18.7 11.8 17.5
Histological subtypea
Squamous 153 13.7 9.5 12.5 14.1
Non-squamous 461 10.8 18.4 10.4 20.2
ECOG PS 2 61 3.3 8.9 3.5 3.6
CNS metastases 90 5.6 NE 5.1 7.5
Autoimmune disease 30 6.7 NE 10.1 6.9
Prior anti–PD-1 therapy 40 5.0 11.6 5.8 NE
Renal impairment 79 13.9 12.7 11.9 15.8
Active/chronic hepatitis B/C 14 14.3 20.7 14.7 13.3
PD-L1 expressionb (OAK-like)
Positive (≥1%) 147 15.0 16.6 15.5 28.4
Negative (<1%) 111 9.0 8.6 11.7 19.1

NE, not evaluable. a One patient was missing data. b Expression on tumour cells using any assay and in biomarker-evaluable patients (n=381).

Clinical trial identification


Editorial acknowledgement

Medical writing assistance for this abstract was provided by Derrick Afful, PhD, of Health Interactions, and funded by F. Hoffmann-La Roche, Ltd.

Legal entity responsible for the study

F. Hoffmann-La Roche, Ltd.


F. Hoffmann-La Roche, Ltd.


A. Ardizzoni: Financial Interests, Personal, Advisory Board: Eli Lilly, Bristol Myers Squibb, MSD, Roche, Astra Zeneca, Takeda, Bayer. B. Rubio-Viqueira: Financial Interests, Personal, Invited Speaker: MSD, Bristol; Financial Interests, Personal, Advisory Board: MSD, Lilly, Takeda. D. Rodriguez-Abreu: Financial Interests, Personal, Other, Personal Fees and other: Bristol Myers Squibb, MSD, Roche/Genentech, Novartis, Astra Zeneca, Boehringer. J. Alatorre-Alexander: Financial Interests, Personal, Advisory Board: Astra Zeneca, Roche, MSD, Bristol Myers Squibb, Takeda, Pfizer; Financial Interests, Personal, Speaker’s Bureau: Roche, MSD, Bristol Myers Squibb, Takeda, Pfizer. H.J.M. Smit: Financial Interests, Personal, Advisory Board: MSD, Bristol Myers Squibb, AstraZeneca; Financial Interests, Institutional, Principal Investigator: MSD, Bristol Myers Squibb, AstraZeneca, Beigene, Roche. E. Hoglander: Financial Interests, Personal, Stocks/Shares: Roche; Financial Interests, Personal, Full or part-time Employment: Roche. M. Kaul: Financial Interests, Personal, Stocks/Shares: Roche; Financial Interests, Personal, Full or part-time Employment: Genentech. J. Tolson, Y. Hu: Financial Interests, Personal, Full or part-time Employment: Roche. H.K. Vollan: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche. T. Newsom-Davis: Financial Interests, Personal, Advisory Board: Amgen, Bayer, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, MSD, Novartis, Otsuka, Pfizer, Roche, Sanofi, Takeda; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Guardant, MSD, Takeda, Roche; Financial Interests, Personal, Sponsor/Funding: AstraZeneca, Bristol Myers Squibb, Boehringer-Ingelheim, Eli Lilly, MSD, Otsuka, Roche, Takeda. All other authors have declared no conflicts of interest.

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