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Poster display session

5277 - CNS response to osimertinib in Asian-Pacific patients (pts) with T790M-positive advanced NSCLC: data from an open-label Phase II trial (AURA17)

Date

09 Sep 2017

Session

Poster display session

Presenters

Caicun Zhou

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

C. Zhou1, Y. Cheng2, Y. Lu3, M. Shi4, J. Han5, M. Wang6, S. Kim7, J. Wang8, Y. Chen8, Y. Wu9

Author affiliations

  • 1 Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, 200433 - Shanghai/CN
  • 2 Department Of Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun/CN
  • 3 Department Of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu/CN
  • 4 Medical Oncology, Jiangsu Cancer Hospital, Nanjing/CN
  • 5 Center For Lung Cancer, National Cancer Center, Goyang/KR
  • 6 Department Of Oncology, Peking Union Medical College Hospital, 100730 - Beijing/CN
  • 7 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul/KR
  • 8 China Development Unit, AstraZeneca, Shanghai/CN
  • 9 Guangdong General Hospital & Guangdong Academy Of Medical Sciences, Guangdong Lung Cancer Institute, 510080 - Guangzhou/CN
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Resources

Abstract 5277

Background

Osimertinib has shown CNS efficacy in a pooled analysis of two Phase II trials (AURA extension: NCT01802632, AURA2: NCT02094261) in pts with T790M-positive advanced NSCLC. We report osimertinib efficacy in CNS metastases (mets) from a Phase II, open-label, single-arm trial (AURA17: NCT02442349) in Asia-Pacific pts with T790M-positive advanced NSCLC who had progressed on prior EGFR-TKI therapy, with or without additional anti-cancer regimens.

Methods

Pts with stable, asymptomatic, CNS mets were eligible for enrolment and received osimertinib 80 mg once daily. This prespecified subgroup analysis was conducted in pts with CNS mets present on baseline brain scan as assessed by blinded independent central neuroradiology review (BICR). Endpoints included CNS objective response rate (ORR), duration of response (DoR) and progression-free survival (PFS) by RECIST 1.1. The CNS full analysis set (cFAS) comprised pts with ≥1 measurable and/or non-measurable CNS lesion present on baseline brain scan by BICR; the CNS evaluable for response set (cEFR) comprised pts with ≥1 measurable CNS lesion.

Results

At the data cut-off of 4 November 2016, 59/171 pts (35%) were included in the cFAS. In the cFAS and cEFR (n = 23), 3 and 0 pts had brain radiotherapy ≤6 months prior to study entry, respectively. CNS ORR was 42% (25/59; 95% CI 30, 56) for the cFAS and 70% (16/23; 95% CI 47, 87) for the cEFR. Median CNS DoR was not reached (95% CI 9.2, not calculable [NC]) for the cFAS and 11.1 months (95% CI 8.2, NC) for the cEFR. CNS DCR was 85% (95% CI 73, 93) for the cFAS and 91% (95% CI 72, 99) for the cEFR. Median CNS PFS was not reached in both cFAS (95% CI 12.4, NC) and cEFR groups (95% CI 9.4, NC), with a median follow-up for CNS PFS of 7.1 and 8.2 months, respectively. At 12 months, 70% (95% CI 53, 82) of pts in the cFAS and 61% (95% CI 31, 81) of pts in the cEFR were estimated to remain on study, alive and CNS progression-free.

Conclusions

These data are consistent with previous reports of CNS response to osimertinib in pts with T790M-positive advanced NSCLC in global studies, and demonstrate clinically meaningful efficacy in Asian-Pacific pts with CNS mets.

Clinical trial identification

NCT02442349

Legal entity responsible for the study

AstraZeneca

Funding

AstraZeneca

Disclosure

C. Zhou: Lecture honorarium: Eli Lily, AZ, Roche, Pfizer, Sanofi, BI, Henrui Advisory board: Roche, BI, AZ. Y. Lu: Consulting or Advisory Role: AstraZeneca, Hoffmann-La Roche, Eli Lilly, Pfizer, Elekta, Varian Medical Systems. J. Wang, Y. Chen: Employee of AstraZeneca. Y-L. Wu: Speaker fees from AstraZeneca, Roche, Eli Lilly, Sanofi, Pfizer. All other authors have declared no conflicts of interest.

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