CNS response to osimertinib in patients with T790M-positive advanced NSCLC: pooled data from two phase II trials
Open accessAbstract
Background: Central nervous system (CNS) metastases are common in patients with non-small-cell lung cancer (NSCLC). Osimertinib has shown systemic efficacy in patients with CNS metastases, and early clinical evidence shows efficacy in the CNS. To evaluate osimertinib activity further, we present a pre-specified subgroup analysis of CNS response using pooled data from two phase II studies: AURA extension (NCT01802632) and AURA2 (NCT02094261). Patients and methods: Patients with T790M-positive advanced NSCLC, who had progressed following prior epidermal growth factor receptor-tyrosine kinase inhibitor treatment, received osimertinib 80 mg od (n = 411). Patients with stable, asymptomatic CNS metastases were eligible for enrolment; prior CNS treatment was allowed. Patients with ≥1 measurable CNS lesion (per RECIST 1.1) on baseline brain scan by blinded independent central neuroradiology review (BICR) were included in the evaluable for CNS response set (cEFR). The primary outcome for this CNS analysis was CNS objective response rate (ORR) by BICR; secondary outcomes included CNS duration of response, disease control rate (DCR) and progression-free survival (PFS). Results: Of 128 patients with CNS metastases on baseline brain scans, 50 were included in the cEFR. Confirmed CNS ORR and DCR were 54% [27/50; 95% confidence interval (CI) 39-68] and 92% (46/50; 95% CI 81-98), respectively. CNS response was observed regardless of prior radiotherapy to the brain. Median CNS duration of response (22% maturity) was not reached (range, 1-15 months); at 9 months, 75% (95% CI 53-88) of patients were estimated to remain in response. Median follow-up for CNS PFS was 11 months; median CNS PFS was not reached (95% CI, 7, not calculable). The safety profile observed in the cEFR was consistent with the overall patient population. Conclusions: Osimertinib demonstrated clinically meaningful efficacy against CNS metastases, with a high DCR, encouraging ORR, and safety profile consistent with that reported previously. ClinicalTrials.gov number: NCT01802632; NCT02094261.
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Osimertinib is able to effectively penetrate the blood-brain barrier, providing a good therapeutic effect on BMS in advanced NSCLC, and significantly extending progression-free survival in cases of central nervous system metastases.
“In addition, multiple studies have demonstrated that osimertinib is able to effectively penetrate the blood-brain barrier,134,135 providing a good therapeutic effect on BMS in advanced NSCLC, and significantly extending progression-free survival in cases of central nervous system (CNS) metastases.136,137”
From Recent advances in targeting the “undruggable” proteins: from drug discovery to clinical trials (2023) · cites this paper as [137]
In two phase II studies of patients with T790M-positive NSCLC and CNS metastasis, osimertinib demonstrated a CNS ORR of 54% and a CNS disease control rate of 92%.
“In two phase II studies of patients with T790Mpositive NSCLC and CNS metastasis, osimertinib demonstrated a CNS ORR of 54% and a CNS disease control rate of 92%. 17”
From Osimertinib for Patients With Non–Small-Cell Lung Cancer Harboring Uncommon EGFR Mutations: A Multicenter, Open-Label, Phase II Trial (KCSG-LU15-09) (2020) · cites this paper as [17]
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Self-citation
- Authors
- Goss, G., Tsai, C.-M., Shepherd, F. A., Ahn, M.-J., Bazhenova, L., Crinò, L., de Marinis, F., Felip, E., Morabito, A., Hodge, R., Cantarini, M., Johnson, M., Mitsudomi, T., Jänne, P. A., & Yang, J. C.-H.
- Affiliations
- University of Ottawa (CA)
- Taipei Veterans General Hospital (TW)
- University Health Network (CA)
- Samsung Medical Center (KR)
- Moores Cancer Center (US)
- Azienda Ospedaliera di Perugia (IT)
- Vall d'Hebron Institute of Oncology (ES)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- AstraZeneca (United Kingdom) (GB)
- Kindai University (JP)
- National Taiwan University Hospital (TW)
- Corresponding author
- Goss, G.
- ORCID
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2018-03
- Volume
- 29
- Issue
- 3
- Pages
- 687-693
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2776194348
- Cited by
- 247
- References
- 27
- Citations by year
- 2026: 5 · 2025: 12 · 2024: 17 · 2023: 32 · 2022: 25 · 2021: 35 · 2020: 30 · 2019: 40 · 2018: 45 · 2017: 6
- FWCI
- 27.37
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Brain Metastases and Treatment
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Keywords
- osimertinib, central nervous system metastasis, disease control rate, progression-free survival, EGFR tyrosine kinase inhibitors, brain metastases, EGFR mutation, targeted therapy, safety profile, subgroup analysis
- MeSH terms
- Progression-Free Survival, Acrylamides, Adult, Aged, Aniline Compounds, Antineoplastic Agents, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Piperazines, Pyrimidines, Central Nervous System Neoplasms, ErbB Receptors
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