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Proffered Paper session - CNS tumours

5380 - Results of Phase 2 Trial of SL-701, a novel immunotherapy targeting IL-13Ra2, EphA2, and survivin, in adults with second-line recurrent glioblastoma (GBM)

Date

19 Oct 2018

Session

Proffered Paper session - CNS tumours

Presenters

David Peereboom

Citation

Annals of Oncology (2018) 29 (suppl_8): viii122-viii132. 10.1093/annonc/mdy273

Authors

D. Peereboom1, L..B. Nabors2, P. Kumthekar3, M. Badruddoja4, K. Fink5, F. Lieberman6, S. Phuphanich7, E. Dunbar8, T. Walbert9, D. Schiff10, D.D. Tran11, L.S. Ashby12, N. Butowski13, F. Iwamoto14, R. Lindsay15, J. Bullington16, M. Schulder17, J. Sherman18, C. Brooks15, D. Reardon19

Author affiliations

  • 1 Brain Tumor And Neuro-oncology Center, Cleveland Clinic Foundation, 44195 - Cleveland/US
  • 2 Neuro-oncology, University of Alabama Comprehensive Cancer Center, Birmingham/US
  • 3 Department Of Neurology And Department Of Medicine, The Ken &Roth Davee, Chicago/US
  • 4 Neuro-oncology, Center for Neurosciences, Tucson/US
  • 5 Neuro-oncology, Baylor Scott&White Neuro-Oncology Associates, Dallas/US
  • 6 Division Of Hematology/oncology, University of Pittsburgh, Pittsburgh/US
  • 7 Department Of Neurology, Barrow Neurological Institute, Phoenix/US
  • 8 Piedmont Brain Tumor Center, Piedmont Helathcare, Atlanta/US
  • 9 Neuro-oncology, Henry Ford Health System, Detroit/US
  • 10 Neurology, University of Virginia School of Medicine, Charlottesville/US
  • 11 Department Of Neurosurgery, University of Florida, Gainesville/US
  • 12 Neuro-oncology, St. Joseph's Hospital and Medical Center, Phoenix/US
  • 13 Neurological Surgery, UCSF, San Francisco/US
  • 14 Neuro-oncology, Columbia University Medical Center, New York/US
  • 15 R&d, Stemline Therapeutics, 10022 - New York/US
  • 16 Clinical, Stemline Therapeutics, 10022 - New York/US
  • 17 Neuo-oncology, North Shore University Hospital, Manhasset/US
  • 18 Neurosurgery, George Washington University, Washignton DC/US
  • 19 Center For Neuro-oncology, Dana-Farber Cancer Institute, 2215 - Boston/US
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Abstract 5380

Background

SL-701 is a novel immunotherapy comprised of synthetic peptides designed to elicit an anti-tumor immune response against targets overexpressed in glioblastoma (GBM): interleukin-13 receptor alpha-2, ephrinA2 and survivin. Updated phase 2 data are reported.

Methods

Patients enrolled had recurrent GBM, were HLA-A2+ and bevacizumab (bev)-naïve, and had KPS>60. In Stage 1, SL-701 was administered with adjuvants GM-CSF and imiquimod biweekly for 6 months, then q28 days. In Stage 2, SL-701 and adjuvant poly-ICLC were administered biweekly with bev (10 mg/kg) for 6 months, then q28 days. Primary objectives included safety, tolerability, investigator-assessed objective response rate (ORR) using RANO criteria, and 12-month overall survival rate (OS-12). SL-701-specific CD8+ T cells in PBMCs isolated from patients were assessed by flow cytometry using antibodies to CD3, CD4, CD8, IFNg, TNFa, IL-2, and PD-1.

Results

Accrual for Stages 1 and 2 is complete. 74 patients [46 in Stage 1 and 28 in Stage 2; 65% male, median age of 57 years [(range: 24-79)] received SL-701. Five patients received SL-701 on compassionate use basis. The most frequent treatment-related adverse events (TRAEs) were fatigue (22%) and injection site reaction (18%). The most frequent grade 3-4 treatment-related adverse event was fatigue (n = 2; 2.7%). In Stage 1, a 22% disease control rate (DCR; CR+PR+SD for > =8 weeks) was observed, comprised of 1 PR (duration: 78 weeks) and 9 SD [median duration: 25 weeks (range: 3.7–120.9)] were observed. In Stage 2, a 54% DCR was observed consisting of 2 CRs (duration: 22 and 46 weeks), 2 PRs (duration: 38 and 54 weeks), and 11 SDs [median duration: 13.6 weeks (range: 1.6 – 35.1)] were observed. OS-12 was 44% in Stage 1 [95% CI 28.9, 58.9] and 50% [95% CI 30.6, 69.4] in Stage 2, and median OS was 11 months in Stage 1 and 11.7 months in Stage 2. Flow cytometry analysis of Stage 2 patients demonstrated CD8+ T cell responses to the SL-701 peptides.

Conclusions

SL-701 plus adjuvants with or without bevacizumab was well-tolerated and demonstrated anti-tumor activity, including multiple major responses and a preliminarily promising survival curve, warranting further study. Updated study data will be presented.

Clinical trial identification

NCT02078648.

Legal entity responsible for the study

Stemline Therapeutics.

Funding

Stemline Therapeutics.

Editorial Acknowledgement

Disclosure

R. Lindsay, J. Bullington, C. Brooks: Employment and stock ownership: Stemline Therapeutics. All other authors have declared no conflicts of interest.

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