Osimertinib versus Standard of Care EGFR TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC

FLAURA Asian Subset

ByoungChul Cho, Busayamas Chewaskulyong, Ki Hyeong Lee, Arunee Dechaphunkul, Virote Sriuranpong, Fumio Imamura, Naoyuki Nogami, Takayasu Kurata, Isamu Okamoto, Caicun Zhou, Ying Cheng, Eun Kyung Cho, Pei Jye Voon, Jong Seok Lee, Helen Mann, Matilde Saggese, Thanyanan Reungwetwattana, Suresh S. Ramalingam, Yuichiro Ohe

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction: Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial (NCT02296125), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI–sensitizing mutations. Methods: Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR-mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). The primary end point was investigator-assessed progression-free survival (PFS). The key secondary end points were overall survival, objective response rate, central nervous system efficacy, and safety. Results: The median PFS was 16.5 versus 11.0 months for the osimertinib and SoC EGFR TKI groups, respectively (hazard ratio = 0.54, 95% confidence interval: 0.41–0.72, p < 0.0001). The overall survival data were immature (24% maturity). The objective response rates were 80% for osimertinib and 75% for an SoC EGFR TKI. The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95% confidence interval: 0.25–1.17, p = 0.118). Fewer adverse events of grade 3 or higher (40% versus 48%) and fewer adverse events leading to treatment discontinuation (15% versus 21%) were reported with osimertinib versus with an SoC EGFR TKI, respectively. Conclusion: In this Asian population, first-line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population.

Original languageEnglish
Pages (from-to)99-106
Number of pages8
JournalJournal of Thoracic Oncology
Volume14
Issue number1
DOIs
Publication statusPublished - 2019 Jan 1

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Standard of Care
Protein-Tyrosine Kinases
Disease-Free Survival
Safety
Therapeutics
Central Nervous System
Confidence Intervals
Survival
osimertinib
Population
Exons
Japan
Research Personnel
Mutation
Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Cho, ByoungChul ; Chewaskulyong, Busayamas ; Lee, Ki Hyeong ; Dechaphunkul, Arunee ; Sriuranpong, Virote ; Imamura, Fumio ; Nogami, Naoyuki ; Kurata, Takayasu ; Okamoto, Isamu ; Zhou, Caicun ; Cheng, Ying ; Cho, Eun Kyung ; Voon, Pei Jye ; Lee, Jong Seok ; Mann, Helen ; Saggese, Matilde ; Reungwetwattana, Thanyanan ; Ramalingam, Suresh S. ; Ohe, Yuichiro. / Osimertinib versus Standard of Care EGFR TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC : FLAURA Asian Subset. In: Journal of Thoracic Oncology. 2019 ; Vol. 14, No. 1. pp. 99-106.
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abstract = "Introduction: Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial (NCT02296125), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI–sensitizing mutations. Methods: Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR-mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). The primary end point was investigator-assessed progression-free survival (PFS). The key secondary end points were overall survival, objective response rate, central nervous system efficacy, and safety. Results: The median PFS was 16.5 versus 11.0 months for the osimertinib and SoC EGFR TKI groups, respectively (hazard ratio = 0.54, 95{\%} confidence interval: 0.41–0.72, p < 0.0001). The overall survival data were immature (24{\%} maturity). The objective response rates were 80{\%} for osimertinib and 75{\%} for an SoC EGFR TKI. The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95{\%} confidence interval: 0.25–1.17, p = 0.118). Fewer adverse events of grade 3 or higher (40{\%} versus 48{\%}) and fewer adverse events leading to treatment discontinuation (15{\%} versus 21{\%}) were reported with osimertinib versus with an SoC EGFR TKI, respectively. Conclusion: In this Asian population, first-line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population.",
author = "ByoungChul Cho and Busayamas Chewaskulyong and Lee, {Ki Hyeong} and Arunee Dechaphunkul and Virote Sriuranpong and Fumio Imamura and Naoyuki Nogami and Takayasu Kurata and Isamu Okamoto and Caicun Zhou and Ying Cheng and Cho, {Eun Kyung} and Voon, {Pei Jye} and Lee, {Jong Seok} and Helen Mann and Matilde Saggese and Thanyanan Reungwetwattana and Ramalingam, {Suresh S.} and Yuichiro Ohe",
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Cho, B, Chewaskulyong, B, Lee, KH, Dechaphunkul, A, Sriuranpong, V, Imamura, F, Nogami, N, Kurata, T, Okamoto, I, Zhou, C, Cheng, Y, Cho, EK, Voon, PJ, Lee, JS, Mann, H, Saggese, M, Reungwetwattana, T, Ramalingam, SS & Ohe, Y 2019, 'Osimertinib versus Standard of Care EGFR TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC: FLAURA Asian Subset', Journal of Thoracic Oncology, vol. 14, no. 1, pp. 99-106. https://doi.org/10.1016/j.jtho.2018.09.004

Osimertinib versus Standard of Care EGFR TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC : FLAURA Asian Subset. / Cho, ByoungChul; Chewaskulyong, Busayamas; Lee, Ki Hyeong; Dechaphunkul, Arunee; Sriuranpong, Virote; Imamura, Fumio; Nogami, Naoyuki; Kurata, Takayasu; Okamoto, Isamu; Zhou, Caicun; Cheng, Ying; Cho, Eun Kyung; Voon, Pei Jye; Lee, Jong Seok; Mann, Helen; Saggese, Matilde; Reungwetwattana, Thanyanan; Ramalingam, Suresh S.; Ohe, Yuichiro.

In: Journal of Thoracic Oncology, Vol. 14, No. 1, 01.01.2019, p. 99-106.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Osimertinib versus Standard of Care EGFR TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC

T2 - FLAURA Asian Subset

AU - Cho, ByoungChul

AU - Chewaskulyong, Busayamas

AU - Lee, Ki Hyeong

AU - Dechaphunkul, Arunee

AU - Sriuranpong, Virote

AU - Imamura, Fumio

AU - Nogami, Naoyuki

AU - Kurata, Takayasu

AU - Okamoto, Isamu

AU - Zhou, Caicun

AU - Cheng, Ying

AU - Cho, Eun Kyung

AU - Voon, Pei Jye

AU - Lee, Jong Seok

AU - Mann, Helen

AU - Saggese, Matilde

AU - Reungwetwattana, Thanyanan

AU - Ramalingam, Suresh S.

AU - Ohe, Yuichiro

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Introduction: Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial (NCT02296125), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI–sensitizing mutations. Methods: Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR-mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). The primary end point was investigator-assessed progression-free survival (PFS). The key secondary end points were overall survival, objective response rate, central nervous system efficacy, and safety. Results: The median PFS was 16.5 versus 11.0 months for the osimertinib and SoC EGFR TKI groups, respectively (hazard ratio = 0.54, 95% confidence interval: 0.41–0.72, p < 0.0001). The overall survival data were immature (24% maturity). The objective response rates were 80% for osimertinib and 75% for an SoC EGFR TKI. The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95% confidence interval: 0.25–1.17, p = 0.118). Fewer adverse events of grade 3 or higher (40% versus 48%) and fewer adverse events leading to treatment discontinuation (15% versus 21%) were reported with osimertinib versus with an SoC EGFR TKI, respectively. Conclusion: In this Asian population, first-line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population.

AB - Introduction: Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial (NCT02296125), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI–sensitizing mutations. Methods: Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR-mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). The primary end point was investigator-assessed progression-free survival (PFS). The key secondary end points were overall survival, objective response rate, central nervous system efficacy, and safety. Results: The median PFS was 16.5 versus 11.0 months for the osimertinib and SoC EGFR TKI groups, respectively (hazard ratio = 0.54, 95% confidence interval: 0.41–0.72, p < 0.0001). The overall survival data were immature (24% maturity). The objective response rates were 80% for osimertinib and 75% for an SoC EGFR TKI. The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95% confidence interval: 0.25–1.17, p = 0.118). Fewer adverse events of grade 3 or higher (40% versus 48%) and fewer adverse events leading to treatment discontinuation (15% versus 21%) were reported with osimertinib versus with an SoC EGFR TKI, respectively. Conclusion: In this Asian population, first-line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population.

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