Abstract 1316P
Background
The FDA approved the PD-L1 inhibitor Atz in 2016 for the treatment of aNSCLC patients who had received prior treatment with platinum-based chemotherapy (Pctx) based on results from the phase III OAK trial versus Dtx. The PD-1 inhibitor Niv was approved in 2015 for the same indication. No studies have compared Atz versus Dtx or Niv in a broad RW population. This study compared overall survival (OS) for Atz versus Dtx and Atz versus Niv in pt patients with aNSCLC.
Methods
We conducted a retrospective analysis of aNSCLC patients from the Flatiron Health database containing electronic health records from over 280 US cancer clinics. Eligible patients had previously received Pctx and initiated Atz, Dtx or Niv between May 2011 and October 2019. These included patients with ALK, ROS1 or EGFR mutations (+), who also received targeted therapy for these mutations as well as Pctx. OS was determined as the time from Atz, Dtx or Niv initiation (index date) to March 1, 2020, death, or last visit, whichever was earlier. Propensity score weighting was used to adjust for differences in baseline patient characteristics.
Results
Eligible patients (N=5037) had a median age of 68 years [interquartile range: 14 years], including 3270 patients with complete information on baseline characteristics. Original (unadjusted) sample sizes and post-weighting Hazard Ratios (HR) with [95% confidence intervals (CI)] are shown in the table. Atz was associated with significantly better OS than Dtx and similar OS to Niv in all analyses including complete case; when excluding ALK/EGFR/ROS1+ patients; when subgrouping by histology, when restricting index date and when imputing missing baseline characteristics such as ECOG. Table: 1316P
| All eligible patients (complete case analysis) | Excluding patients ALK+/EGFR+/ROS1+ | Patients with non-squamous histology | Index date ≥2015 | All eligible patients (multiple imputation for missing baseline characteristics) | |
| Exposure | N and HR (95% CI) | N and HR | N and HR | N and HR | N and HR |
| Atz | N= 202, HR= 0.78 [0.64-0.96] | N=182, HR=0.77 [0.62-0.96] | N=140, HR=0.69 [0.53-0.89] | N=202, HR=0.75 [0.58-0.96] | N=265, HR=0.78 [0.65-0.94] |
| Dtx (Ref) | N= 494 | N= 448 | N= 356 | N= 166 | N= 946 |
| Atz | N=202, HR=1.08 [0.89-1.3] | N=182, HR=1.10 [0.9-1.33] | N=140, HR=0.91 [0.71-1.18] | N=202, HR=1.07 [0.88-1.3] | N=265, HR=1.08 [0.91-1.3] |
| Niv (Ref) | N= 2574 | N= 2350 | N= 855 | N= 1303 | N= 3826 |
Conclusions
Our results showed RW benefit of Atz versus Dtx, and RW similarity of Atz and Niv in a broad population of US pt aNSCLC patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
F. Hoffmann-La Roche.
Funding
F. Hoffmann-La Roche.
Disclosure
V. Subbiah: Financial Interests, Personal, Research Grant: PharmaMar; Financial Interests, Personal, Research Grant: Loxo; Financial Interests, Personal, Research Grant: Novartis; Financial Interests, Personal, Research Grant: Bayer; Financial Interests, Personal, Research Grant: GSK; Financial Interests, Personal, Research Grant: Nanocarrier; Financial Interests, Personal, Research Grant: Vegenics; Financial Interests, Personal, Research Grant: Celgene; Financial Interests, Personal, Research Grant: Northwest Biotherapeutics; Financial Interests, Personal, Research Grant: BERG Health; Financial Interests, Personal, Research Grant: Incyte; Financial Interests, Personal, Research Grant: Fujifilm; Financial Interests, Personal, Research Grant: D3; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: Multivir; Financial Interests, Personal, Research Grant: Amgen; Financial Interests, Personal, Research Grant: AbbVie; Financial Interests, Personal, Research Grant: Alfa-sigma; Financial Interests, Personal, Research Grant: Agensys; Financial Interests, Personal, Research Grant: Boston Biomedical; Financial Interests, Personal, Research Grant: Idea Pharma; Financial Interests, Personal, Research Grant: Inhibrx; Financial Interests, Personal, Research Grant: Exelix. A. Gupta: Financial Interests, Personal, Full or part-time Employment: Cytel. J. Ray: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche. P. Arora: Financial Interests, Personal, Full or part-time Employment: Cytel. K. Thorlund: Financial Interests, Personal, Full or part-time Employment: Cytel. S. Ramagopalan: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann-La Roche.