372P - 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

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.

Clinical trial identification

Editorial acknowledgement

Medical writing assistance was provided by Esmie Lynn Wescott PhD of Oxford PharmaGenesis, funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

This study is sponsored by AstraZeneca and involves the analysis of data drawn from CRISP. CRISP is an AIO study (AIO-TRK-0315), conducted and sponsored by AIO-Studien-gGmbH in collaboration with iOMEDICO (conception, project management and analysis). The CRISP study is supported by grants from Amgen Ltd., AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol Myers Squibb GmbH & Co. KGaA, Celgene GmbH, Janssen-Cilag GmbH, Lilly Deutschland GmbH, Merck Sharp & Dohme GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, and Takeda Pharma Vertrieb GmbH & Co. KG.

Disclosure

F. Griesinger: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Celgene, GlaxoSmithKline, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi, Siemens, Takeda; Financial Interests, Personal, Research Grant: Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Celgene, GlaxoSmithKline, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Siemens, Takeda. S. Popat: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Chugai Pharmaceutical, Roche, Takeda; Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Guardant Health, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi, Takeda. L. Servidio: Financial Interests, Personal, Stocks/Shares: AstraZeneca. All other authors have declared no conflicts of interest.