Overall survival (OS) in patients (pts) with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC) treated with osimertinib: Results from two phase II studies

Mitsudomi, Tetsuya; Ahn, M-J.; Bazhenova, Lyudmila; Blackhall, Fiona; Hida, Toyoaki; Tarruella, M. Majem; Vowler, Sarah L.; Laus, G.; Yang, J.C.H.

doi:10.1093/annonc/mdx380.050

Cited by 15 publications

(15 citation statements)

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“…Though the OS data from the Aura 3 study are not available, the updated results from a pooled analysis of two Phase II studies (namely, the AURA extension and AURA2 studies) indicated that there was no significant difference between the second‐line and ≥third‐line cohorts, who received 80 mg of osimertinib once daily, in terms of median OS (95% CI, 25.8 versus 24.0). The 12‐month and 24‐month survival rates were 80% and 56%, respectively . In this study, we found that the 1‐year OS rate was 66.1%, which was slightly lower than that found in a previous report.…”

Section: Discussioncontrasting

confidence: 80%

Real‐world outcomes of NSCLC patients receiving tissue or circulating tumor DNA‐guided osimertinib treatment

Yang

Chen

et al. 2019

Cancer Medicine

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Background Osimertinib yields significant tumor responses and durations of progression‐free survival (PFS) in patients with acquired T790M mutations. However, the evidence supporting liquid biopsy‐guided treatment is still limited. This study examined the real‐world benefits of osimertinib in patients with tissue or plasma T790M mutations. Methods From January 2016 to June 2018, a total of 183 non‐small‐cell lung cancer patients were enrolled. The presence of the T790M mutation was assessed by either tissue or plasma. The PFS, overall survival, and tumor response rates of the patients were calculated and compared with those of previous clinical trials. Results T790M mutations were detected in 51.5% of the patients, including 64 of 140 (45.7%) who underwent liquid biopsies and 23 of 29 (79.3%) who underwent tumor biopsies. After excluding those in clinical trials, 46 patients received osimertinib, including 33 with positive plasma and 13 with positive tissue results for T790M mutations. The median PFS was 11.3 months (interquartile range: 5.2‐NR) in all the T790M‐positive patients and 10.1 months (interquartile range: 5.9‐NR) in the plasma T790M‐positive patients. The overall survival, meanwhile, was not reached, whereas the one‐year survival rate was 66.1% in all the patients and 61.4% in those who were plasma T790M‐positive. The objective response rate and disease control rate were 37.8% and 91.9% in all the patients and 34.6% and 92.3% in the plasma T790M‐positive group, respectively. Using a Cox proportional hazards regression, we determined that male gender was a poor prognostic factor for PFS. Conclusions In this retrospective real‐world analysis, it was determined that both tissue and plasma T790M mutations can be used to guide treatment with osimertinib. Similar disease control rates and survival durations were observed in comparison to those of phase 3 clinical trials.

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Section: Discussioncontrasting

confidence: 80%

Real‐world outcomes of NSCLC patients receiving tissue or circulating tumor DNA‐guided osimertinib treatment

Yang

Chen

et al. 2019

Cancer Medicine

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“…Similarly, in the AURA2 study in patients who had progression on previous EGFR TKI therapy, the response rate was 70% [37]. Pooled OS analysis from AURA2 and the AURA extension showed median OS of 26.8 months from initiation of osimertinib in patients with T790M-positive NSCLC that had progressed after a first-or second-line EGFR TKI [38]. Osimertinib was subsequently assessed in the randomized Phase III AURA3 trial in patients with T790M-positive advanced NSCLC who had disease progression after first-line EGFR TKI therapy.…”

Section: Third-generation Egfr Tkis In Patients With Acquired Resistancementioning

confidence: 91%

Optimizing outcomes in EGFR Mutation-Positive Nsclc: Which Tyrosine Kinase Inhibitor and When?

Girard

2018

Future Oncol.

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Despite the efficacy of standard-of-care EGFR tyrosine kinase inhibitors (TKIs), erlotinib, gefitinib and afatinib, in EGFR mutation-positive non-small-cell lung cancer, resistance develops, most commonly due to the T790M mutation. Osimertinib showed clinical activity in the treatment of T790M-positive disease following progression on a first-line TKI, and is approved in this setting. Recently, osimertinib improved efficacy versus first-generation TKIs (erlotinib and gefitinib) in the first-line setting. Multiple factors can influence first-line treatment decisions, including subsequent therapy options, presence of brain metastases and tolerability, all of which should be considered in the long-term treatment plan. Further research into treatment sequencing is also needed, to optimize outcomes in EGFR mutation-positive non-small-cell lung cancer.

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“…[14][15][16] Other less common mechanisms are MET amplification (up to 20% of cases) and histologic transformation to small-cell lung cancer (10%-15% of cases). 17,18 The third-generation EGFR TKI osimertinib is active against exon 19 deletion and exon 21 mutation as well as against the T790M mutation, [19][20][21][22] displaying prolonged PFS (10.1 vs. 4.4 months; hazard ratio, 0.30) and response rate (71% vs. 31%) when compared with platinum-based second-line chemotherapy in the phase III AZD9291 Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (AURA3) trial. 23 More recently, the phase III AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA) trial showed longer PFS (18.9 vs. 10.2 months; hazard ratio, 0.46) with osimertinib compared with gefitinib or erlotinib in previously untreated patients.…”

Section: Introductionmentioning

confidence: 99%

Clinical Features and Progression Pattern of Acquired T790M-positive Compared With T790M-negative EGFR Mutant Non–small-cell Lung Cancer: Catching Tumor and Clinical Heterogeneity Over Time Through Liquid Biopsy

Maso

Roca

Pilotto

et al. 2020

Clinical Lung Cancer

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Overall survival (OS) in patients (pts) with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC) treated with osimertinib: Results from two phase II studies

Cited by 15 publications

References 0 publications

Real‐world outcomes of NSCLC patients receiving tissue or circulating tumor DNA‐guided osimertinib treatment

Real‐world outcomes of NSCLC patients receiving tissue or circulating tumor DNA‐guided osimertinib treatment

Optimizing outcomes in EGFR Mutation-Positive Nsclc: Which Tyrosine Kinase Inhibitor and When?

Clinical Features and Progression Pattern of Acquired T790M-positive Compared With T790M-negative EGFR Mutant Non–small-cell Lung Cancer: Catching Tumor and Clinical Heterogeneity Over Time Through Liquid Biopsy

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