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Poster Display session 1

3832 - Osimertinib in epidermal growth factor receptor (EGFR) T790M advanced non-small cell lung cancer (NSCLC): analysis of patients with central nervous system (CNS) metastases in a real-world study (ASTRIS)

Date

28 Sep 2019

Session

Poster Display session 1

Topics

Tumour Site

Non-Small Cell Lung Cancer

Presenters

Giulio Metro

Citation

Annals of Oncology (2019) 30 (suppl_5): v602-v660. 10.1093/annonc/mdz260

Authors

G. Metro1, M. Provencio2, D. Kim3, B.C. Cho4, K. Park5, Y. Pan6, Y. Shi7, R. Migliorino8, M. Tiseo9, J. Yu10, Q. Zhou11, A. Santo12, A. Ardizzoni13, Y. Hu14, Y. Wu11, S. Kim15, M. Miranda16, A. Fernandes17, F. de Marinis18

Author affiliations

  • 1 Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, 06129 - Perugia/IT
  • 2 Medical Oncology Department, Hospital Universitario Puertade de Hierro, Majadahonda, IDHIPSA, 28222 - Madrid/ES
  • 3 Department Of Internal Medicine, Seoul National University Hospital, 110-744 - Seoul/KR
  • 4 Oncology, Yonsei Cancer Research Institute, Yonsei University College of Medicine, 03722 - Seoul/KR
  • 5 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 6 Department Of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, 230032 - Hefei/CN
  • 7 Department Of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center, Chinese Academy of Medical Science and Peking Union Medical College, Beijing/CN
  • 8 Department Of Thoracic Oncology, San Camillo-Forlanini Hospitals, Rome/IT
  • 9 Medical Oncology Unit, University Hospital of Parma, 43126 - Parma/IT
  • 10 Department Of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan/CN
  • 11 Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou/CN
  • 12 Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integra (AOUI) Verona, 37134 - Verona/IT
  • 13 Medical Oncology, S.Orsola-Malpighi University Hospital, Bologna/IT
  • 14 Department Of Oncology, Hubei Cancer Hospital, Wuhan/CN
  • 15 Department Of Oncology, Asan Medical Center, 138-736 - Seoul/KR
  • 16 Biometrics And Information Sciences, AstraZeneca, Cambridge/GB
  • 17 Global Medical Affairs, AstraZeneca US, Gaithersburg/US
  • 18 Division Of Thoracic Oncology, European Institute of Oncology IRCCS, 20141 - Milan/IT

Resources

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Abstract 3832

Background

Approximately 20%–30% of patients (pts) with EGFR mutation-positive NSCLC present with CNS metastases at the time of diagnosis of advanced disease. CNS metastases are associated with a poor prognosis. Osimertinib is a third-generation, irreversible, oral EGFR-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitising (EGFRm) and EGFR T790M mutations and in clinical trials has demonstrated efficacy in NSCLC CNS metastases. ASTRIS is the largest ongoing, international, real-world study of osimertinib in EGFR T790M positive advanced NSCLC (NCT02474355). We report a subset analysis of pts with CNS metastases.

Methods

Eligible pts with stage IIIB/IV EGFR T790M positive NSCLC previously treated with an EGFR-TKI received osimertinib 80 mg once-daily. Investigator-assessed (IA) progression-free survival (PFS), clinical response and time to treatment discontinuation (TTD) were analysed in a subset of pts with CNS (leptomeningeal and/or brain) metastases at baseline (BL). Follow-up brain imaging was not mandatory.

Results

From 18 September 2015 to 15 October 2018, 3015 pts across 16 countries had received ≥1 dose of osimertinib (full analysis set [FAS]); 882 (29%) pts presented with CNS metastases at BL. BL demographics were similar between this subset and the FAS (female: 63%/64%; Asian: 69%/69%; median age (range): 61 (27–88) years/62 (27–92); WHO performance status 2: 15%/11%). IA response rates were consistent across the two groups, while median PFS and TTD appeared to be slightly lower in the CNS subset (Table). Overall survival data are immature.Table:

1521P Clinical outcomes for pts with EGFR T790M advanced NSCLC and CNS metastases at BL

Clinical outcomesFAS Osimertinib 80 mg (N = 3015)CNS subset Osimertinib 80 mg (N = 882)
Response rate*, % (95% CI)57 (55, 59)59 (55, 62)
Best overall response, n (%) Responding Stable disease Progressive disease Unknown 1655 (55) 1043 (35) 202 (7) 115 (4) 485 (55) 274 (31) 66 (7) 57 (6)
Median PFS, months (95% CI)11.1 (11.0, 12.0)9.7 (9.2, 10.5)
Median TTD, months (95% CI)13.5 (12.6, 13.9)11.1 (10.1, 12.1)

CI, confidence interval

*

Response rate is defined as the percentage of pts with a best response of ’Responding’ by investigator assessment, based on pts with ≥1 documented response assessment. 95% CI is defined by Clopper-Pearson method †Best overall response is defined as the best response by investigator assessment. Pts with no assessments were considered as ’Unknown’

Conclusions

In a real-world setting, over half of pts with EGFR T790M positive advanced NSCLC and CNS metastases responded to treatment with osimertinib 80 mg. These findings support previous clinical research showing clinically meaningful CNS efficacy with osimertinib in advanced NSCLC.

Clinical trial identification

NCT02474355.

Editorial acknowledgement

Bernadette Tynan, MSc, of iMed Comms, Macclesfield, UK, an Ashfield Company, part of UDG Healthcare plc, funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

M. Provencio: Advisory / Consultancy: BMS, MSD, AstraZeneca, BI; Travel / Accommodation / Expenses: MSD, AstraZeneca. D. Kim: Research grant / Funding (institution): Alpha Biopharma, AstraZeneca/MedImmune, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan. B.C. Cho: Honoraria (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, BMS, Pfizer, Eli Lilly, Takeda, TheraCanVac Inc.; Advisory / Consultancy: Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, BMS, Pfizer, Eli Lilly, Takeda, TheraCanVac Inc.; Speaker Bureau / Expert testimony: Novartis; Research grant / Funding (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD; Shareholder / Stockholder / Stock options: TheraCanVac Inc.; Licensing / Royalties: Champions Oncology. K. Park: Advisory / Consultancy: AMGEN, AstraZeneca, Astellas, BluePrint, Eli Lilly, Hanmi, KHK, MSD, Boehringer Ingelheim, Roche, Merck KGaA, Ono; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Research grant / Funding (self): AstraZeneca. R. Migliorino: Advisory / Consultancy: AstraZeneca, MSD, BI, Pfizer, Roche, BMS; Speaker Bureau / Expert testimony: AstraZeneca, MSD, BI, Pfizer, Roche, BMS; Travel / Accommodation / Expenses: AstraZeneca, MSD, BI, Pfizer, Roche, BMS. M. Tiseo: Advisory / Consultancy: AstraZeneca, BMS, MSD, Boehringer Ingelheim, Takeda; Research grant / Funding (institution): AstraZeneca. Q. Zhou: Honoraria (self): AstraZeneca, Roche. A. Santo: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca, Roche. A. Ardizzoni: Honoraria (self): MSD, BMS, Pfizer, Eli Lilly; Advisory / Consultancy: MSD, Roche; Research grant / Funding (institution): BMS, Celgene, Roche. Y. Wu: Honoraria (self): AstraZeneca, Roche, Eli Lilly, Pfizer, MSD, BMS, Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca, Roche, Boehringer Ingelheim; Research grant / Funding (institution): AstraZeneca, Roche. S. Kim: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca. M. Miranda: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca PLC. A. Fernandes: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. F. de Marinis: Honoraria (self), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Roche, Celgene, MSD, BMS, AstraZeneca, Takeda, Pfizer; Research grant / Funding (self): Boehringer Ingelheim, MSD. All other authors have declared no conflicts of interest.

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