Abstract 9P
Background
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.
Methods
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.
Results
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.
Conclusions
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
NCT03285763.
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.
Funding
F. Hoffmann-La Roche, Ltd.
Disclosure
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.