Hypothesis generative head-to-head study comparing efficacy of afatinib and osimertinib based on immunological biomarkers in Japanese NSCLC patients with EGFR mutations (Heat on Beat study)

Therapeutic Advances in Medical Oncology
Kei MorikawaNobuhiko Seki

Abstract

In the FLAURA trial, superiority of osimertinib over the standard of care (SOC) was not demonstrated in Asian patients; SOC seemed favorable among Japanese patients (hazard ratio 1.39, 95% confidence interval 0.82-2.33). Three reasons are suggested: since rechallenge with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) is covered by health insurance in Japan, EGFR-TKI rechallenge rate was higher in SOC than in the osimertinib group, which resulted in a long-term sequential administration of EGFR-TKIs; treatment discontinuation rate was high in the osimertinib group due to adverse events such as interstitial pneumonia among Japanese patients. EGFR-TKIs enhance tumor antigen-specific cytotoxicity of T cells, especially first- and second-generation EGFR-TKIs, which are more active against various cells with wild-type EGFR, including regulatory T cells. Consequently, subsequent immune checkpoint inhibitor therapy seemed more promising in the SOC group. Therefore, optimal first-line EGFR-TKI for EGFR-mutant advanced lung cancer may not have been identified in Japanese patients. The Heat on Beat study is a randomized, open-label, multicenter, phase II study to compare OS between initial treatment with afatinib a...Continue Reading

References

Mar 14, 2008·American Journal of Respiratory and Critical Care Medicine·Shoji KudohFredrik Nyberg
Jun 25, 2010·The New England Journal of Medicine·Makoto MaemondoUNKNOWN North-East Japan Study Group
Jan 31, 2012·The Lancet Oncology·Rafael RosellUNKNOWN Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia T
Mar 9, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Helena A YuGregory J Riely
Jul 3, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Lecia V SequistMartin Schuler
Apr 21, 2017·Annals of Oncology : Official Journal of the European Society for Medical Oncology·L Paz-AresK Park
Apr 29, 2018·Molecular Cancer Therapeutics·Tomomi Nakayama IwataToshinori Agatsuma
Jun 5, 2018·The New England Journal of Medicine·Mark A SocinskiUNKNOWN IMpower150 Study Group
Jun 5, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Tony S MokYi-Long Wu
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Nov 22, 2019·The New England Journal of Medicine·Suresh S RamalingamUNKNOWN FLAURA Investigators

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Methods Mentioned

BETA
biopsy
irradiation
FCS
FACS

Software Mentioned

FlowJo
FLAURA
Cytobank
Prism
SAS

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