Abstract 63P
Background
Based on the results of the FLAURA randomized clinical trial (RCT), osimertinib monotherapy is indicated as the first-line treatment (1L) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations (EGFRm). However, there is a need to replicate the RCT outcomes in a real-world setting with a more generalizable study population defined by less strict selection criteria, including patients with worse PS and several comorbidities. We aimed to describe the effectiveness of osimertinib monotherapy in patients with locally advanced or metastatic EGFRm NSCLC that are not amenable to curative surgery or radiotherapy.
Methods
This is an observational, ambispective, multicenter, multicohort study based on real-world data. Adult patients diagnosed with EGFRm mNSCLC who received osimertinib as 1L treatment in Spain were included in the analysis. Patients who initiated osimertinib between 2018 (since EMA approval in June 2018) and 2023 at 23 participating centers in Spain were included in this cohort. Progression-free survival (PFS) was estimated using the Kaplan-Meier method.
Results
326 patients were included in the study and 306 were evaluable for effectiveness. Patients were predominantly female (67%) and had a mean (SD) age of 67.1 (11.3) years (30% were ≥75 years). ECOG-PS was 0 (n=77, 30.4%), 1 (n=123, 48.6%) and ≥2 (n=53, 20.9%). Most patients had stage IVA (n=109, 36%) and IVB (n=121, 40%) disease, and 14 (5%) had CNS metastases. EGFR mutation types were as follows: exon 19 (n=164, 54%), exon 21 L858R (n=102, 33%), co-mutation (common and uncommon; n=20, 6.5%), and uncommon (n=20, 6,5%). With a total event number of 228 (75.25%) and a median follow-up of 21.4 months, the median PFS was 16.4 months (95% CI, 13.9–18.5). The PFS rates at 6, 12, and 18 months were 80.2% (95% CI, 75.3%–84.3%), 59.7% (95% CI, 53.9%–65.0%), and 38.0% (95% CI, 32.3%–43.6%), respectively.
Conclusions
In this cohort of patients from real-world practice in Spain, osimertinib monotherapy achieved a similar median PFS despite the patients having a worse PS and being older than those in the FLAURA trial.
Editorial acknowledgement
Editorial assistance provided by APICES.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
D. Rodriguez Abreu: Financial Interests, Personal, Advisory Board: MSD, Novartis, Roche/Genentech, Pfizer, Bristol Myers Squibb, AstraZeneca, Regeneron, Gilead, Sanofi, Amgen, Eli Lilly, Incyte, Merck Serono; Financial Interests, Personal, Invited Speaker: MSD, Novartis, Roche/Genentech, Pfizer, Bristol Myers Squibb, AstraZeneca, Regeneron, Gilead, Sanofi, Amgen, Eli Lilly, Merck Serono; Financial Interests, Personal, Other, Travel expenses: MSD, Novartis, Roche/Genentech, Pfizer. M.E. Lazaro: Financial Interests, Personal, Speaker’s Bureau: MSD, AstraZeneca, BMS, Ipsen, Roche, Lilly, Bayer; Financial Interests, Personal, Expert Testimony: MSD, BMS, Merck; Financial Interests, Personal, Other, Support for attending meetings and/or travel: Ipsen, MSD, Roche. R. Bernabe Caro: Financial Interests, Personal, Advisory Board: Roche, Bristol; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Lilly, Sanofi, Janssen. L.A. Leon Mateos: Financial Interests, Personal, Expert Testimony: AstraZeneca, Bristol Myers Squibb, Merck, MSD, Roche, Sanofi, Takeda; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Bristol Myers Squibb, Jansen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda; Financial Interests, Personal, Other, Support for attending meetings and/or travel: AstraZeneca, Bristol Myers Squibb, Jansen, MSD, Pfizer, Roche, Sanofi, Takeda. O.J. Juan Vidal: Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Roche/Genentech, Lilly, Takeda, AstraZeneca, Janssen; Financial Interests, Personal, Other, Travel expenses: MSD; Financial Interests, Personal, Invited Speaker: Bristol-Myers Squib, Amgen, Roche/Genentech, Pfizer; Financial Interests, Institutional, Funding: AstraZeneca. R. López Castro: Financial Interests, Personal, Advisory Board: AstraZeneca, Roche, Novartis, Amgen, Pierre Fabre. A. Azkárate Martínez: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, MSD, BMS, Pfizer, Takeda, Lilly, Amgen; Financial Interests, Personal and Institutional, Invited Speaker: Amgen, Mirati, Bayer, Takeda, Pfizer, Roche, AstraZeneca, Lilly. E. Arriola Aperribay: Financial Interests, Institutional, Research Grant: AstraZeneca, BMS; Financial Interests, Personal, Speaker’s Bureau: Lilly, AstraZeneca, Takeda, MSD, Pfizer, Janssen, BMS; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Other, Support for attending meetings and/or travel: AstraZeneca, Roche, Pfizer; Financial Interests, Institutional, Invited Speaker, Receipt of equipment, materials, drugs, medical writings or other services: AstraZeneca. S. Sequero Lopez: Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Novartis, MSD, Pierre fabre, Sanofi; Financial Interests, Personal, Advisory Board: Roche, AstraZeneca, Novartis, Incyte, Pierre-Fabre, Sanofi, Gilead; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Roche, Pierre Fabre. A. Artal: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Roche, Takeda, Pfizer, Pierre-Fabre. J.L. Gonzalez-Larriba: Financial Interests, Personal, Invited Speaker: MSD Oncology, AstraZeneca, Roche, Pfizer, Janssen Cilag, Novartis, Astellas Pharma, Bristol Myers Squibb, Novartis, Boehringer Ingelheim, AbbVie, Celgene, Mirati Threapeutics, Ignyta, PharmaMar, Oncomed, Bayer; Financial Interests, Personal, Advisory Board: MSD Oncology, Janssen Cilag, Bristol Myers Squibb, Boehringer Ingelheim, Amgen. B. Massuti Sureda: Non-Financial Interests, Personal, Other, Travel Grants: Roche; Financial Interests, Personal, Other, Travel Grants: MSD, AstraZeneca, Bristol Myers Squibb; Financial Interests, Personal, Other: Takeda, Beigene. A. Cardena: Financial Interests, Personal, Invited Speaker: AstraZeneca, Takeda, BMS, Roche; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Personal, Principal Investigator: BMS, AstraZeneca. S. Ros Martinez: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: Merk, Pfizer, MSD, Ipsen, Roche. B. Hernandez Marin: Non-Financial Interests, Institutional, Invited Speaker: AstraZeneca, Pfizer, MSD, GSK, Regeneron. Á. Callejo, A. Soto Simon, M. Dominguez: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. All other authors have declared no conflicts of interest.