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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Presentations: 1
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
158TiP - Open label, multi-center, prospective study to investigate the efficacy and safety of osimertinib in brain metastases from patients with EGFR T790M positive NSCLC who have received prior therapy with an EGFR-TKI (APOLLO Study, NCT02972333) (ID 250)
12:30 - 13:00 | Author(s): L. Xing
The development of EGFR-TKI have led to significant advances in patients with tumors harboring EGFR mutations (EGFRm). However, increasing incidence of central nervous system (CNS) metastasis (∼40%), including leptomeningeal metastasis (LM) and brain metastasis (BM), has been reported, particular in EGFR mutant NSCLC receiving EGFR TKI treatment. Due to limited blood brain barrier (BBB) penetration of current EGFR inhibitors (i.e. 1st generation EGFR TKIs such as gefitinib, erlotinib or icotinib and 2nd generation TKIs e.g. afatinib), these drugs can only exhibit limited efficacy on CNS metastasis. Furthermore, the acquiring resistance may commonly occur due to the development of EGFR T790M mutation. Osimertinib is a novel oral, potent and irreversible inhibitor of both EGFRm sensitizing and T790M resistance mutants. In a combined analysis from AURA (NCT01802632) and AURA2 (NCT02094261) study, the ORR of pts with CNS metastases was 56%, whilst 64% in pts without CNS metastases, demonstrating the potential benefits of osimertinib in pts with BM.
This is an open label, multi-center, prospective study to investigate the efficacy and safety of osimertinib in pts with BM. Pts with confirmed EGFR T790M positive NSCLC who received prior therapy with an EGFR-TKI and concurrent with brain metastasis will be enrolled. All eligible patients will have access to osimertinib 80mg once-daily as long as they show clinical benefit as judged by the investigator and in the absence of discontinuation criteria. All consenting pts will be required to provide CSF and blood samples pre-treatment, 6 weeks after treatment and at PD. All pts receiving osimertinib will be followed for clinical outcomes (tumor response, survival, etc) and patient reported outcomes at baseline and every 12 weeks (± 7days investigator per RECIST 1.1 until objective disease progression, intolerant toxicity, loss of follow up). A sample size of 100 patients will provide 80% power to evaluate the treatment profile of Osimertinib and its impact on the molecular evolution. The First subject in is on 11[th] January, 2017.
Clinical trial identification:
APOLLO Study (protocol number: NCT02972333) was released on November 23, 2016.
Legal entity responsible for the study:
Jinming Yu, Shandong Cancer Hospital
All authors have declared no conflicts of interest.