Global real-world (rw) study of patients (pts) with epidermal growth factor receptor (EGFR) mutated advanced non-small cell lung cancer (NSCLC) treated with first-line (1L) osimertinib: interim analysis of an rw pt registry in Germany

F Griesinger; S Popat; P Okhuoya; L Servidio; M Fonseca; E Tolani; S Lu; S Zacharias; M Thomas

doi:10.1055/s-0043-1760897

Pneumologie, Inhaltsverzeichnis

Pneumologie 2023; 77(S 01): S14
DOI: 10.1055/s-0043-1760897

Abstracts

Global real-world (rw) study of patients (pts) with epidermal growth factor receptor (EGFR) mutated advanced non-small cell lung cancer (NSCLC) treated with first-line (1L) osimertinib: interim analysis of an rw pt registry in Germany

Autoren

F Griesinger

¹Pius-Hospital Oldenburg; University Medicine Oldenburg; Hematology/Oncology, Internal Medicine-Oncology
S Popat

²Department of Medicine, The Royal Marsden Hospital – NHS Foundation Trus
P Okhuoya

³Astrazeneca
L Servidio

⁴Global Medical Affairs Department, Astrazeneca US
M Fonseca

⁵Iqvia, Porto Salvo
E Tolani

⁶Iqvia
S Lu

⁷Medical Oncology Department, Shanghai Chest Hospital, Shanghai Jiao Tong University
S Zacharias

⁸Department of Data Management, Statistics and Medical Informatics, Iomedico
M Thomas

⁹Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg

Abstract

Volltext

Background EGFR tyrosine kinase inhibitors (TKIs) are the standard 1L treatment for pts with advanced NSCLC with EGFR mutations (EGFRm). Osimertinib is a third-generation, irreversible EGFR TKI that selectively inhibits sensitizing and T790M mutations, and is effective in NSCLC central nervous system metastases. In this global rw study, an interim analysis was conducted to evaluate the characteristics and outcomes in pts with advanced EGFRm NSCLC receiving 1L osimertinib in Germany.

Methods In an ongoing, multicountry prospective study, data for pts with EGFRm NSCLC receiving 1L osimertinib were extracted from the CRISP registry (AIO-TRK-0315) in Germany. Pts initiating treatment with 1L osimertinib between June 2018 and December 2020 (index date) were followed until June 2021 for this interim analysis. Further follow-up is planned until 2023. Time to event outcomes (with 95% confidence interval [CI]) were analyzed using Kaplan–Meier analysis, with progression-free survival (PFS), time to next treatment or death (TTNTD) and time to discontinuation (TTD) analyses measured from index date. Patients who do not have an event or died at the end of follow-up will be censored.

Results Of 217 pts, 98.2% had stage IV EGFRm NSCLC, 96.3% had adenocarcinoma and 38.2% had brain metastases. Pts had a mean age of 67.3 years, 66.4% were female, and 84.4% and 15.6% had ECOG performance scores of 0/1 and 2/3, respectively, when known. Median follow-up was 16.4 months (mo; 95% CI, 12.9–18.2). Median PFS was 16.2 mo (95% CI, 12.4–24.5); 95/217 (43.8%) of pts had an event. The median TTNTD was 19.2 mo (95% CI, 14.1–NA) and median TTD was 14.8 mo (95% CI, 12.7–19.7). By the cut-off (30 June 2021), 51.6% are continuing to receive 1L osimertinib treatment, 9.2% completed 1L osimertinib treatment, 14.3% received any second-line treatment, and 24.9% died while on or after receiving 1L osimertinib treatment.

Conclusions This study demonstrates the rw effectiveness of 1L osimertinib in pts with advanced EGFRm NSCLC, supported by the interim PFS, TTNTD and TTD. Further analysis is warranted to determine longer-term outcomes in the final analysis.

Funded by AstraZeneca.