Author of

• 18374

  +

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

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18473

    +

    P3.02b-099 - Pharmacokinetics of Osimertinib (AZD9291) in Chinese Patients with Advanced NSCLC: A Phase I Study (ID 4440)

    14:30 - 14:30  |  Author(s): J. Cao
    • Abstract

    Background:
    Osimertinib is a potent, irreversible epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), selective for EGFR-sensitising (EGFRm) and T790M resistance mutations. The Phase I AURA18 study (NCT02529995) assessed osimertinib pharmacokinetics (PK) in Chinese patients with advanced non-small cell lung cancer (aNSCLC) who progressed following prior EGFR-TKI therapy.
    
    Methods:
    Osimertinib is a potent, irreversible epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI), selective for EGFR-sensitising (EGFRm) and T790M resistance mutations. The Phase I AURA18 study (NCT02529995) assessed osimertinib pharmacokinetics (PK) in Chinese patients with advanced non-small cell lung cancer (aNSCLC) who progressed following prior EGFR-TKI therapy.
    
    Results:
    31 patients were treated (Cohort 1, n=15; Cohort 2, n=16): median age, 57.0 years; female, 58%; never smokers, 74%. 26 harboured tumors with the EGFR T790M mutation (local test). The PK analysis set included 25 patients: 6 were excluded due to prior treatment with an osimertinib-like substance or a T790M-directed EGFR-TKI. Osimertinib exposure increased approximately dose-proportionally after single and multiple dosing, similar to previous global studies. 29 (94%) patients experienced at least one adverse event (AE), 3 patients experienced an AE of Grade ≥3; no patients discontinued treatment due to AEs. The most common AEs were: diarrhoea (32%), white blood cell decreased (23%), neutrophil count decreased (19%), dry mouth and erythema (19%). ORR (all partial responses) in T790M mutation-positive subgroup was 36% for Cohort 1 (4/11; 95% CI 11, 69) and 67% for Cohort 2 (10/15; 95% CI 38, 88).
    
    Conclusion:
    Osimertinib PK in the AURA18 Chinese patient population is consistent with the global population and supports 80 mg once-daily dosing. Clinical benefit and a tolerable safety profile were demonstrated. Figure 1