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Lazertinib versus Gefitinib as First-Line Treatment for EGFR-Mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset.

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Title: Lazertinib versus Gefitinib as First-Line Treatment for EGFR-Mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset.
Authors: Ki Hyeong Lee, Byoung Chul Cho, Myung-Ju Ahn, Yun-Gyoo Lee, Youngjoo Lee, Jong-Seok Lee, Joo-Hang Kim, Young Joo Min, Gyeong-Won Lee, Sung Sook Lee, Kyung-Hee Lee, Yoon Ho Ko, Byoung Yong Shim, Sang-We Kim, Sang Won Shin, Jin-Hyuk Choi, Dong-Wan Kim, Eun Kyung Cho, Keon Uk Park, Jin-Soo Kim
Source: Cancer Research & Treatment; Jan2024, Vol. 56 Issue 1, p48-60, 13p
Subject Terms: EPIDERMAL growth factor receptors, GEFITINIB, NON-small-cell lung carcinoma, KOREANS, CLINICAL trials
Abstract: Purpose This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Materials and Methods Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS). Results In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment-related AEs occurred with lazertinib than gefitinib. Conclusion Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population. [ABSTRACT FROM AUTHOR]
Copyright of Cancer Research & Treatment is the property of Korean Cancer Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Label: Title
  Group: Ti
  Data: Lazertinib versus Gefitinib as First-Line Treatment for EGFR-Mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset.
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  Data: <searchLink fieldCode="AR" term="%22Ki+Hyeong+Lee%22">Ki Hyeong Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Byoung+Chul+Cho%22">Byoung Chul Cho</searchLink><br /><searchLink fieldCode="AR" term="%22Myung-Ju+Ahn%22">Myung-Ju Ahn</searchLink><br /><searchLink fieldCode="AR" term="%22Yun-Gyoo+Lee%22">Yun-Gyoo Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Youngjoo+Lee%22">Youngjoo Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Jong-Seok+Lee%22">Jong-Seok Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Joo-Hang+Kim%22">Joo-Hang Kim</searchLink><br /><searchLink fieldCode="AR" term="%22Young+Joo+Min%22">Young Joo Min</searchLink><br /><searchLink fieldCode="AR" term="%22Gyeong-Won+Lee%22">Gyeong-Won Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Sung+Sook+Lee%22">Sung Sook Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Kyung-Hee+Lee%22">Kyung-Hee Lee</searchLink><br /><searchLink fieldCode="AR" term="%22Yoon+Ho+Ko%22">Yoon Ho Ko</searchLink><br /><searchLink fieldCode="AR" term="%22Byoung+Yong+Shim%22">Byoung Yong Shim</searchLink><br /><searchLink fieldCode="AR" term="%22Sang-We+Kim%22">Sang-We Kim</searchLink><br /><searchLink fieldCode="AR" term="%22Sang+Won+Shin%22">Sang Won Shin</searchLink><br /><searchLink fieldCode="AR" term="%22Jin-Hyuk+Choi%22">Jin-Hyuk Choi</searchLink><br /><searchLink fieldCode="AR" term="%22Dong-Wan+Kim%22">Dong-Wan Kim</searchLink><br /><searchLink fieldCode="AR" term="%22Eun+Kyung+Cho%22">Eun Kyung Cho</searchLink><br /><searchLink fieldCode="AR" term="%22Keon+Uk+Park%22">Keon Uk Park</searchLink><br /><searchLink fieldCode="AR" term="%22Jin-Soo+Kim%22">Jin-Soo Kim</searchLink>
– Name: TitleSource
  Label: Source
  Group: Src
  Data: Cancer Research & Treatment; Jan2024, Vol. 56 Issue 1, p48-60, 13p
– Name: Subject
  Label: Subject Terms
  Group: Su
  Data: <searchLink fieldCode="DE" term="%22EPIDERMAL+growth+factor+receptors%22">EPIDERMAL growth factor receptors</searchLink><br /><searchLink fieldCode="DE" term="%22GEFITINIB%22">GEFITINIB</searchLink><br /><searchLink fieldCode="DE" term="%22NON-small-cell+lung+carcinoma%22">NON-small-cell lung carcinoma</searchLink><br /><searchLink fieldCode="DE" term="%22KOREANS%22">KOREANS</searchLink><br /><searchLink fieldCode="DE" term="%22CLINICAL+trials%22">CLINICAL trials</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Purpose This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Materials and Methods Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS). Results In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment-related AEs occurred with lazertinib than gefitinib. Conclusion Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label:
  Group: Ab
  Data: <i>Copyright of Cancer Research & Treatment is the property of Korean Cancer Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.4143/crt.2023.453
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        Text: English
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