LBA2_PR: Osimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) and pooled Phase 2 (P2) results

Yang, J.; Ramalingam, S.S.; Jänne, P.A.; Cantarini, M.; Mitsudomi, T.

doi:10.1016/s1556-0864(16)30325-2

Cited by 97Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

LBA2_PR: Osimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) and pooled Phase 2 (P2) results

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Yang, J., Ramalingam, S.S., Jänne, P.A., Cantarini, M., Mitsudomi, T.·2016·Journal of Thoracic Oncology

DOI 10.1016/s1556-0864(16)30325-2

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Osimertinib is an oral irreversible EGFR-TKI selective for EGFR and T790M resistance mutations with CNS activity.
“Osimertinib is an oral, irreversible EGFR-TKI that is selective for both EGFR and T790M resistance mutations with activity in the central nervous system (CNS).19–21”
From Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer (2017) · cites this paper as [21]
The AURA3 outcomes with osimertinib (median PFS 10.1 months, response rate 71%) were in line with results from phase 1/2 AURA and AURA2 studies.
“Among patients receiving osimertinib, the AURA3 outcomes (median progression-free survival duration of 10.1 months and response rate of 71%) were in line with results of the phase 1/2 AURA and AURA2 studies.22,23”
From Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer (2017) · cites this paper as [23]
The safety profile for osimertinib was consistent with that reported previously and differed from that in the platinum-pemetrexed group.
“In AURA3, the safety profile for osimertinib was consistent with that reported previously and differed from that in the platinum–pemetrexed group.23”
From Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer (2017) · cites this paper as [23]
In the BLOOM study, 20 patients with leptomeningeal metastases from EGFR mutation-positive NSCLC treated with osimertinib 160 mg daily showed preliminary radiologic improvement in 7 patients.
“In the BLOOM study (), in which 20 patients with leptomeningeal metastases from EGFR mutation–positive non–small-cell lung cancer were treated with osimertinib (at a dose of 160 mg once daily), preliminary results showed radiologic improvement in 7 patients.21”
From Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer (2017) · cites this paper as [21]
In a pooled analysis of two phase 2 studies of osimertinib 80 mg daily in 411 T790M-positive NSCLC patients, response rate was 66% by blinded independent central review and median PFS was 11.0 months.
“These findings were confirmed in a pooled analysis of two subsequent phase 2 studies of osimertinib (at a dose of 80 mg once daily) in 411 patients with T790M-positive non–small-cell lung cancer, in which the response rate was 66% on blinded independent central review and the median duration of progression-free survival was 11.0 months.23”
From Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer (2017) · cites this paper as [23]

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“AZD9291 (osimertinib), a novel TKI that specifically and irreversibly binds the cysteine-797 residue in the ATP binding site of EGFR, has recently obtained the accelerated Food and Drugs Administration (FDA) approval in EGFR mutated NSCLC with documented T790M resistance mutation, on the basis of important results of…”
Background
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Osimertinib
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Background
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“A pre-planned pooled analysis of two phase II studies, the AURA phase II extension cohort and AURA2 trial, confirmed the efficacy findings (10).”
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Background
Epidermal Growth Factor Receptor Mutated Advanced Non–Small Cell Lung Cancer
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“[132,133] The AURA3 trial confirmed osimertinib’s superiority over platinum plus pemetrexed, with a significantly higher ORR (71% vs .”
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“%) experienced ILD.41 The influence of the T790M-resistance mutation highlights the importance of retesting for mutation status at each subsequent progression.”
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Authors: Yang, J., Ramalingam, S. S., Jänne, P. A., Cantarini, M., & Mitsudomi, T.
Affiliations: National Taiwan University Hospital (TW)
Emory University (US)
AstraZeneca (United Kingdom) (GB)
Kindai University (JP)
ORCID: Yang, J.
Ramalingam, S.S.
Cantarini, M.
Mitsudomi, T.
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2016-04
Volume: 11
Issue: 4
Pages: S152-S153
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/s1556-0864(16)30325-2
OpenAlex: W2336745060
Cited by: 97
References: 0
Citations by year: 2026: 1 · 2025: 1 · 2023: 2 · 2021: 1 · 2020: 6 · 2019: 5 · 2018: 22 · 2017: 40 · 2016: 19
FWCI: 25.65
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
Locations: Journal of Thoracic Oncology (publishedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: osimertinib, EGFR tyrosine kinase inhibitors, T790M mutation, advanced non-small cell lung cancer, EGFR mutation, first-line therapy, pooled analysis, oral targeted therapy

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