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S. Jenkins



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    MA08 - Treatment Monitoring in Advanced NSCLC (ID 386)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA08.03 - Osimertinib vs Platinum-Pemetrexed for T790M-Mutation Positive Advanced NSCLC (AURA3): Plasma ctDNA Analysis (ID 4733)

      11:12 - 11:18  |  Author(s): S. Jenkins

      • Abstract
      • Presentation
      • Slides

      Background:
      AURA3 (NCT02151981) is a Phase III, open-label, randomised study assessing the efficacy and safety of osimertinib, a T790M directed EGFR-TKI, vs platinum-based doublet chemotherapy in patients with EGFR T790M-positive advanced NSCLC, whose tumours progressed on previous EGFR-TKI therapy. Concordance between plasma and tissue testing, and efficacy outcomes by baseline plasma T790M status, were evaluated.

      Methods:
      Eligible patients were randomised 2:1 to osimertinib 80 mg orally once daily or platinum-pemetrexed (pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 or carboplatin AUC5) every three weeks for up to six cycles. Patients were tumour tissue T790M-positive (by cobas[®] EGFR Mutation Test v2) from a biopsy after disease progression prior to study entry. Blood samples were taken at baseline for retrospective analysis of T790M mutation status by plasma ctDNA using the cobas[®] EGFR Mutation Test v2.

      Results:
      Concordance data are reported in the table. Within the intent-to-treat (ITT) population (n=419), patients plasma T790M-positive and randomised to treatment (n=172) had markedly improved progression-free survival (PFS) by investigator assessment (IA) with osimertinib vs platinum-pemetrexed: hazard ratio 0.42 (95% CI: 0.29, 0.61); median 8.2 vs 4.2 months. Objective response rate (ORR) by IA was also distinctly improved with osimertinib vs platinum-pemetrexed: 77% vs 39% (odds ratio 4.96 [95% CI: 2.49, 10.15]; p<0.001). This is consistent with the ITT population: PFS hazard ratio 0.30 (95% CI: 0.23, 0.41); p<0.001 (median 10.1 vs 4.4 months); ORR 71% vs 31% (odds ratio 5.39 [95% CI: 3.47, 8.48]; p<0.001). Figure 1



      Conclusion:
      In plasma T790M-positive patients the clinical benefit of osimertinib was superior to platinum-pemetrexed, consistent with the ITT T790M-positive population selected by tumour tissue test. PFS with osimertinib was similar regardless of selection by tissue or plasma T790M-positive status. Based on these, and AURA Phase II data, routine biopsy testing is recommended for patients with a plasma T790M-negative test where feasible.

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    P3.02b - Poster Session with Presenters Present (ID 494)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P3.02b-021 - Comparing T790M Identification across Testing Strategies in Advanced EGFR NSCLC: A Diagnostic Outcomes and Cost Analysis (ID 4752)

      14:30 - 14:30  |  Author(s): S. Jenkins

      • Abstract

      Background:
      T790M is an acquired mutation in patients (pts) with advanced non-small cell lung cancer (aNSCLC) treated with an EGFR TKI. The tumours of approximately 60% pts treated with an EGFR TKI harbour the T790M mutation upon disease progression. With the launch of treatments targeting T790M in EGFR aNSCLC it is important to identify pts with T790M who will benefit from such therapy. However not all pts are able to undergo tissue biopsy for testing and the advent of ctDNA testing via plasma sample may increase the number of pts with access to a T790M test. This analysis assesses outcomes and costs of different diagnostic testing strategies for T790M in aNSCLC post-EGFR TKI.

      Methods:
      Estimates of T790M mutation prevalence and test performance were applied to a hypothetical cohort of 100 pts. Outcomes were number of true positive / true negative (TP / TN) samples and associated testing costs. The following testing strategies were assessed: i) tissue test only ii) plasma followed by tissue for pts who tested negative using plasma or, iii) both tissue and plasma tests concurrently. Total costs were also estimated for the sample procedure (biopsy or plasma extraction), laboratory testing, and biopsy adverse events (5% rate).

      Results:
      In sequence or concurrent testing (strategies ii & iii) produced the highest number of TP results (n=57) followed by tissue test alone (n=53). Tissue & plasma concurrently (iii) was associated with the highest total costs followed by tissue test only (i) and the lowest cost plasma followed by tissue for pts who tested negative (ii).

      Conclusion:
      To maximise identification of T790M, and hence the most pts who would benefit from targeted therapy, access to both plasma and tissue testing is advantageous. Plasma followed by tissue for pts who tested negative may also be a cost minimising option for healthcare systems compared to tissue testing alone.