ORCID Profile
0000-0002-5562-270X
Current Organisations
Severance Hospital, Yonsei University Health System
,
Yonsei University College of Medicine
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Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487226.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717520
Abstract: Kaplan–Meier estimates showing investigator-assessed PFS in FLAURA trial patients by clearance or non-clearance of plasma EGFRm status at Weeks 3 or 6 in patients who had baseline detectable plasma EGFRm. For comparison, patients with baseline non-detectable plasma EGFRm are included. A, Osimertinib arm by Week 3 plasma EGFRm status (n = 238). B, Comparator EGFR-TKI arm by Week 3 plasma EGFRm status (n = 243). C, Osimertinib arm by Week 6 plasma EGFRm status (n = 240). D, Comparator EGFR-TKI arm by Week 6 plasma EGFRm status (n = 235). Censored data are indicated by tick marks. Abbreviations: CI, confidence interval EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) NC, not calculable mPFS, median PFS TKI, tyrosine kinase inhibitor.
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717523
Abstract: FLAURA flow diagram for ctDNA analysis (n = 499). Clearance refers to non-detectable plasma EGFRm, where EGFRm was detectable at baseline. *There were 3 patients in the osimertinib arm and 7 patients in the comparator EGFR-TKI arm without a valid ddPCR result at Weeks 3 and 6 these s les were excluded from the ctDNA clearance analysis. Abbreviations: ctDNA, circulating tumor DNA EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) TKI, tyrosine kinase inhibitor.
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487232.V1
Abstract: Supplementary Data from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: Massachusetts Medical Society
Date: 16-11-2017
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.C.6752094.V1
Abstract: AbstractPurpose: Plasma circulating tumor DNA (ctDNA) analysis is used for genotyping advanced non–small cell lung cancer (NSCLC) monitoring dynamic ctDNA changes may be used to predict outcomes. Patients and Methods: This was a retrospective, exploratory analysis of two phase III trials [AURA3 (NCT02151981), FLAURA (NCT02296125)]. All patients had EGFR mutation-positive (EGFRm ex19del or L858R) advanced NSCLC AURA3 also included T790M-positive NSCLC. Osimertinib (FLAURA, AURA3), or comparator EGFR–tyrosine kinase inhibitor (EGFR-TKI gefitinib/erlotinib FLAURA), or platinum-based doublet chemotherapy (AURA3) was given. Plasma i EGFR /i m was analyzed at baseline and Weeks 3/6 by droplet digital PCR. Outcomes were assessed by detectable/non-detectable baseline plasma i EGFR /i m and plasma i EGFR /i m clearance (non-detection) at Weeks 3/6. Results: In AURA3 ( i n /i = 291), non-detectable versus detectable baseline plasma i EGFR /i m had longer median progression-free survival [mPFS HR, 0.48 95% confidence interval (CI), 0.33–0.68 i P /i 0.0001]. In patients with Week 3 clearance versus non-clearance ( i n /i = 184), respectively, mPFS (months 95% CI) was 10.9 (8.3–12.6) versus 5.7 (4.1–9.7) with osimertinib and 6.2 (4.0–9.7) versus 4.2 (4.0–5.1) with platinum-pemetrexed. In FLAURA ( i n /i = 499), mPFS was longer with non-detectable versus detectable baseline plasma i EGFR /i m (HR, 0.54 95% CI, 0.41–0.70 i P /i 0.0001). For Week 3 clearance versus non-clearance ( i n /i = 334), respectively, mPFS was 19.8 (15.1 to not calculable) versus 11.3 (9.5–16.5) with osimertinib and 10.8 (9.7–11.1) versus 7.0 (5.6–8.3) with comparator EGFR-TKI. Similar outcomes were observed by Week 6 clearance/non-clearance. Conclusions: Plasma i EGFR /i m analysis as early as 3 weeks on-treatment has the potential to predict outcomes in EGFRm advanced NSCLC. /
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717526
Abstract: Assessment of correlation between EGFRm VAF in baseline plasma and investigator-assessed PFS in A, patients from the AURA3 trial, by treatment arm and B, patients from the FLAURA trial, by treatment arm. Abbreviations: CR, complete response EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) NE, not evaluable PD, progressive disease PFS, progression-free survival PR, partial response SD, stable disease VAF, variant allelic fraction.
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717529
Abstract: Kaplan–Meier estimates showing OS in all trial patients with a valid baseline (detectable or non-detectable) plasma ctDNA result in A, patients from the AURA3 trial (n = 291) and B, patients from the FLAURA trial (n = 499). Censored data are indicated by tick marks. Abbreviations: CI, confidence interval EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) HR, hazard ratio mOS, median overall survival NC, not calculable.
Publisher: Springer Science and Business Media LLC
Date: 23-09-2015
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
DOI: 10.1158/1078-0432.C.6752094
Abstract: AbstractPurpose: Plasma circulating tumor DNA (ctDNA) analysis is used for genotyping advanced non–small cell lung cancer (NSCLC) monitoring dynamic ctDNA changes may be used to predict outcomes. Patients and Methods: This was a retrospective, exploratory analysis of two phase III trials [AURA3 (NCT02151981), FLAURA (NCT02296125)]. All patients had EGFR mutation-positive (EGFRm ex19del or L858R) advanced NSCLC AURA3 also included T790M-positive NSCLC. Osimertinib (FLAURA, AURA3), or comparator EGFR–tyrosine kinase inhibitor (EGFR-TKI gefitinib/erlotinib FLAURA), or platinum-based doublet chemotherapy (AURA3) was given. Plasma i EGFR /i m was analyzed at baseline and Weeks 3/6 by droplet digital PCR. Outcomes were assessed by detectable/non-detectable baseline plasma i EGFR /i m and plasma i EGFR /i m clearance (non-detection) at Weeks 3/6. Results: In AURA3 ( i n /i = 291), non-detectable versus detectable baseline plasma i EGFR /i m had longer median progression-free survival [mPFS HR, 0.48 95% confidence interval (CI), 0.33–0.68 i P /i 0.0001]. In patients with Week 3 clearance versus non-clearance ( i n /i = 184), respectively, mPFS (months 95% CI) was 10.9 (8.3–12.6) versus 5.7 (4.1–9.7) with osimertinib and 6.2 (4.0–9.7) versus 4.2 (4.0–5.1) with platinum-pemetrexed. In FLAURA ( i n /i = 499), mPFS was longer with non-detectable versus detectable baseline plasma i EGFR /i m (HR, 0.54 95% CI, 0.41–0.70 i P /i 0.0001). For Week 3 clearance versus non-clearance ( i n /i = 334), respectively, mPFS was 19.8 (15.1 to not calculable) versus 11.3 (9.5–16.5) with osimertinib and 10.8 (9.7–11.1) versus 7.0 (5.6–8.3) with comparator EGFR-TKI. Similar outcomes were observed by Week 6 clearance/non-clearance. Conclusions: Plasma i EGFR /i m analysis as early as 3 weeks on-treatment has the potential to predict outcomes in EGFRm advanced NSCLC. /
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487217.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: Elsevier BV
Date: 08-2014
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717529.V1
Abstract: Kaplan–Meier estimates showing OS in all trial patients with a valid baseline (detectable or non-detectable) plasma ctDNA result in A, patients from the AURA3 trial (n = 291) and B, patients from the FLAURA trial (n = 499). Censored data are indicated by tick marks. Abbreviations: CI, confidence interval EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) HR, hazard ratio mOS, median overall survival NC, not calculable.
Publisher: Massachusetts Medical Society
Date: 27-08-2020
Publisher: Massachusetts Medical Society
Date: 02-01-2020
Publisher: American Association for Cancer Research (AACR)
Date: 28-06-2023
DOI: 10.1158/1078-0432.CCR-22-3146
Abstract: Plasma circulating tumor DNA (ctDNA) analysis is used for genotyping advanced non–small cell lung cancer (NSCLC) monitoring dynamic ctDNA changes may be used to predict outcomes. This was a retrospective, exploratory analysis of two phase III trials [AURA3 (NCT02151981), FLAURA (NCT02296125)]. All patients had EGFR mutation-positive (EGFRm ex19del or L858R) advanced NSCLC AURA3 also included T790M-positive NSCLC. Osimertinib (FLAURA, AURA3), or comparator EGFR–tyrosine kinase inhibitor (EGFR-TKI gefitinib/erlotinib FLAURA), or platinum-based doublet chemotherapy (AURA3) was given. Plasma EGFRm was analyzed at baseline and Weeks 3/6 by droplet digital PCR. Outcomes were assessed by detectable/non-detectable baseline plasma EGFRm and plasma EGFRm clearance (non-detection) at Weeks 3/6. In AURA3 (n = 291), non-detectable versus detectable baseline plasma EGFRm had longer median progression-free survival [mPFS HR, 0.48 95% confidence interval (CI), 0.33–0.68 P & 0.0001]. In patients with Week 3 clearance versus non-clearance (n = 184), respectively, mPFS (months 95% CI) was 10.9 (8.3–12.6) versus 5.7 (4.1–9.7) with osimertinib and 6.2 (4.0–9.7) versus 4.2 (4.0–5.1) with platinum-pemetrexed. In FLAURA (n = 499), mPFS was longer with non-detectable versus detectable baseline plasma EGFRm (HR, 0.54 95% CI, 0.41–0.70 P & 0.0001). For Week 3 clearance versus non-clearance (n = 334), respectively, mPFS was 19.8 (15.1 to not calculable) versus 11.3 (9.5–16.5) with osimertinib and 10.8 (9.7–11.1) versus 7.0 (5.6–8.3) with comparator EGFR-TKI. Similar outcomes were observed by Week 6 clearance/non-clearance. Plasma EGFRm analysis as early as 3 weeks on-treatment has the potential to predict outcomes in EGFRm advanced NSCLC.
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487229.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717532
Abstract: Correlation between EGFRm allelic fraction at baseline by ddPCR (Biodesix) and NGS (Guardant Health) analyses in A, patients from the AURA3 trial (n = 202) and B, patients from the FLAURA trial (n = 347). Abbreviations: ddPCR, droplet digital PCR EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) NGS, next-generation sequencing.
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717520.V1
Abstract: Kaplan–Meier estimates showing investigator-assessed PFS in FLAURA trial patients by clearance or non-clearance of plasma EGFRm status at Weeks 3 or 6 in patients who had baseline detectable plasma EGFRm. For comparison, patients with baseline non-detectable plasma EGFRm are included. A, Osimertinib arm by Week 3 plasma EGFRm status (n = 238). B, Comparator EGFR-TKI arm by Week 3 plasma EGFRm status (n = 243). C, Osimertinib arm by Week 6 plasma EGFRm status (n = 240). D, Comparator EGFR-TKI arm by Week 6 plasma EGFRm status (n = 235). Censored data are indicated by tick marks. Abbreviations: CI, confidence interval EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) NC, not calculable mPFS, median PFS TKI, tyrosine kinase inhibitor.
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717535
Abstract: AURA3 flow diagram for ctDNA analysis (n = 291). Clearance refers to non-detectable plasma EGFRm, where EGFRm was detectable at baseline. *There were 9 patients in the osimertinib arm and 1 patient in the platinum-pemetrexed arm without a valid ddPCR result at Weeks 3 and 6 these s les were excluded from the ctDNA clearance analysis. Abbreviations: ctDNA, circulating tumor DNA EGFRm, epidermal growth factor receptor mutation (ex19del or L858R).
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487208.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487229
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717514.V1
Abstract: Univariable and multivariable analyses for OS from the AURA3 trial (ctDNA evaluable population, n = 291) and FLAURA trial (ctDNA evaluable population, n = 499).
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487232
Abstract: Supplementary Data from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487214.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717523.V1
Abstract: FLAURA flow diagram for ctDNA analysis (n = 499). Clearance refers to non-detectable plasma EGFRm, where EGFRm was detectable at baseline. *There were 3 patients in the osimertinib arm and 7 patients in the comparator EGFR-TKI arm without a valid ddPCR result at Weeks 3 and 6 these s les were excluded from the ctDNA clearance analysis. Abbreviations: ctDNA, circulating tumor DNA EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) TKI, tyrosine kinase inhibitor.
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717517.V1
Abstract: Representativeness of study participants
Publisher: American Association for Cancer Research (AACR)
Date: 10-02-2022
DOI: 10.1158/1078-0432.CCR-21-3597
Abstract: Entrectinib potently inhibits tropomyosin receptor kinases (TRKAs)/B/C and ROS1, and previously induced deep [objective response rate (ORR) 57.4%] and durable [median duration of response (DoR) 10.4 months] responses in adults with NTRK fusion-positive solid tumors from three phase I/II trials. This article expands prior reports with additional patients and longer follow-up. Patients with locally advanced/metastatic NTRK fusion-positive solid tumors and ≥12 months' follow-up were included. Primary endpoints were ORR and DoR by blinded independent central review (BICR) secondary endpoints included progression-free survival (PFS), intracranial efficacy, and safety. The safety-evaluable populations included all patients who had received ≥1 entrectinib dose. At clinical cut-off (August 31, 2020), the efficacy-evaluable population comprised 121 adults with 14 tumor types and ≥30 histologies. Median follow-up was 25.8 months 61.2% of patients had a complete (n = 19) or partial response (n = 55). Median DoR was 20.0 months [95% confidence interval (CI), 13.0–38.2] median PFS was 13.8 months (95% CI, 10.1–19.9). In 11 patients with BICR-assessed measurable central nervous system (CNS) disease, intracranial ORR was 63.6% (95% CI, 30.8–89.1) and median intracranial DoR was 22.1 (95% CI, 7.4–not estimable) months. The safety profile of entrectinib in adults and pediatric patients was aligned with previous reports. Most treatment-related adverse events (TRAEs) were grade 1/2 and manageable/reversible with dose modifications. TRAE-related discontinuations occurred in 8.3% of patients. With additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses and can address the unmet need of a CNS-active treatment in patients with NTRK fusion-positive solid tumors.
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487217
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: MDPI AG
Date: 11-01-2023
DOI: 10.3390/NU15020366
Abstract: Increasing evidence supports that a higher dietary inflammatory index (DII®) score is associated with inflammation and cardiovascular disease (CVD) risk, events, and mortality. This randomized trial sought to determine if a change to a Mediterranean diet resulted in a reduction in the DII score, and then it evaluated the relationship between the DII and cardiometabolic outcomes following the administration of a traditional Mediterranean diet in older Australian adults. A total of 152 Australian adults (mean age 71 ± 5 years) was randomly allocated either a MedDiet (n = 80) or to continue their habitual diet (HabDiet) (n = 72) for 6 months. Diet and cardiovascular outcomes were measured at baseline and 3 and 6 months of the intervention. DII and energy-adjusted DII (E-DIITM) scores were calculated from 3-day weighed food records. There was a significant reduction in the DII score at 2 and 4 months for the MedDiet group (−1.40 ± 0.20 p 0.001 and −1.47 ± 0.20 p 0.001, respectively), which was significantly different from the HabDiet group over time (p 0.001). The HabDiet DII score did not change significantly at the 2 and 4 months timepoints (0.47 ± 0.21 p = 0.35 and 0.54 ± 0.21 p = 0.21, respectively). The improvement in the DII in the MedDiet group was not related to any cardiometabolic outcome. Baseline cross-sectional analyses identified a positive association between the E-DII score and average BMI, body weight, WHR, abdominal adiposity, and SBP, and a negative association with HDL-C. We demonstrate that a MedDiet intervention significantly reduced DII scores compared with a habitual Australian diet in older Australians. This could be beneficial for healthy ageing and the avoidance of chronic disease in Western populations.
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487226
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487223
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717532.V1
Abstract: Correlation between EGFRm allelic fraction at baseline by ddPCR (Biodesix) and NGS (Guardant Health) analyses in A, patients from the AURA3 trial (n = 202) and B, patients from the FLAURA trial (n = 347). Abbreviations: ddPCR, droplet digital PCR EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) NGS, next-generation sequencing.
Publisher: Massachusetts Medical Society
Date: 11-01-2018
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487211.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487220
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487220.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487223.V1
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717514
Abstract: Univariable and multivariable analyses for OS from the AURA3 trial (ctDNA evaluable population, n = 291) and FLAURA trial (ctDNA evaluable population, n = 499).
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717526.V1
Abstract: Assessment of correlation between EGFRm VAF in baseline plasma and investigator-assessed PFS in A, patients from the AURA3 trial, by treatment arm and B, patients from the FLAURA trial, by treatment arm. Abbreviations: CR, complete response EGFRm, epidermal growth factor receptor mutation (ex19del or L858R) NE, not evaluable PD, progressive disease PFS, progression-free survival PR, partial response SD, stable disease VAF, variant allelic fraction.
Publisher: Elsevier BV
Date: 11-2017
Publisher: American Association for Cancer Research (AACR)
Date: 20-07-2023
DOI: 10.1158/1078-0432.23717517
Abstract: Representativeness of study participants
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487208
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487214
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.C.6532467.V1
Abstract: AbstractPurpose: Entrectinib potently inhibits tropomyosin receptor kinases (TRKAs)/B/C and ROS1, and previously induced deep [objective response rate (ORR) 57.4%] and durable [median duration of response (DoR) 10.4 months] responses in adults with i NTRK /i fusion-positive solid tumors from three phase I/II trials. This article expands prior reports with additional patients and longer follow-up. Patients and Methods: Patients with locally advanced/metastatic i NTRK /i fusion-positive solid tumors and ≥12 months' follow-up were included. Primary endpoints were ORR and DoR by blinded independent central review (BICR) secondary endpoints included progression-free survival (PFS), intracranial efficacy, and safety. The safety-evaluable populations included all patients who had received ≥1 entrectinib dose. Results: At clinical cut-off (August 31, 2020), the efficacy-evaluable population comprised 121 adults with 14 tumor types and ≥30 histologies. Median follow-up was 25.8 months 61.2% of patients had a complete ( i n /i = 19) or partial response ( i n /i = 55). Median DoR was 20.0 months [95% confidence interval (CI), 13.0–38.2] median PFS was 13.8 months (95% CI, 10.1–19.9). In 11 patients with BICR-assessed measurable central nervous system (CNS) disease, intracranial ORR was 63.6% (95% CI, 30.8–89.1) and median intracranial DoR was 22.1 (95% CI, 7.4–not estimable) months. The safety profile of entrectinib in adults and pediatric patients was aligned with previous reports. Most treatment-related adverse events (TRAEs) were grade 1/2 and manageable/reversible with dose modifications. TRAE-related discontinuations occurred in 8.3% of patients. Conclusions: With additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses and can address the unmet need of a CNS-active treatment in patients with i NTRK /i fusion-positive solid tumors. /
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.C.6532467
Abstract: AbstractPurpose: Entrectinib potently inhibits tropomyosin receptor kinases (TRKAs)/B/C and ROS1, and previously induced deep [objective response rate (ORR) 57.4%] and durable [median duration of response (DoR) 10.4 months] responses in adults with i NTRK /i fusion-positive solid tumors from three phase I/II trials. This article expands prior reports with additional patients and longer follow-up. Patients and Methods: Patients with locally advanced/metastatic i NTRK /i fusion-positive solid tumors and ≥12 months' follow-up were included. Primary endpoints were ORR and DoR by blinded independent central review (BICR) secondary endpoints included progression-free survival (PFS), intracranial efficacy, and safety. The safety-evaluable populations included all patients who had received ≥1 entrectinib dose. Results: At clinical cut-off (August 31, 2020), the efficacy-evaluable population comprised 121 adults with 14 tumor types and ≥30 histologies. Median follow-up was 25.8 months 61.2% of patients had a complete ( i n /i = 19) or partial response ( i n /i = 55). Median DoR was 20.0 months [95% confidence interval (CI), 13.0–38.2] median PFS was 13.8 months (95% CI, 10.1–19.9). In 11 patients with BICR-assessed measurable central nervous system (CNS) disease, intracranial ORR was 63.6% (95% CI, 30.8–89.1) and median intracranial DoR was 22.1 (95% CI, 7.4–not estimable) months. The safety profile of entrectinib in adults and pediatric patients was aligned with previous reports. Most treatment-related adverse events (TRAEs) were grade 1/2 and manageable/reversible with dose modifications. TRAE-related discontinuations occurred in 8.3% of patients. Conclusions: With additional clinical experience, entrectinib continues to demonstrate durable systemic and intracranial responses and can address the unmet need of a CNS-active treatment in patients with i NTRK /i fusion-positive solid tumors. /
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 31-03-2023
DOI: 10.1158/1078-0432.22487211
Abstract: Supplementary Figure from Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Patients With i NTRK /i Fusion-Positive Solid Tumors
Publisher: American Association for Cancer Research (AACR)
Date: 09-2023
Location: Korea, Republic of
No related grants have been discovered for Byoung Chul Cho.