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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5905 - Synthetic DNA Immunotherapy in Biochemically Relapsed Prostate Cancer

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Immunotherapy

Tumour Site

Prostate Cancer

Presenters

Neal Shore

Citation

Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284

Authors

N. Shore1, E.I. Heath2, L.T. Nordquist3, H. Cheng4, K. Bhatt5, M. Morrow6, T. McMullan7, K. Kraynyak6, J. Lee8, B. Sacchetta8, L. Liu6, S. Rosencranz8, S.T. Tagawa9, L.J. Appleman10, R. Tutrone11, J. Garcia12, Y. Whang13, W. Kelly14, I. Csiki8, M.L. Bagarazzi8

Author affiliations

  • 1 Urology, Carolina Urologic Research Center, 29572 - Myrtle Beach/US
  • 2 Oncology, Karmanos Cancer Center, 48201 - Detroit/US
  • 3 Medical Oncology, Urology Cancer Center and GU Research Network, 68130-5606 - Omaha/US
  • 4 Medical Oncology, University of Washington School of Medicine, 98109 - seattle/US
  • 5 Clinical, Inovio Pharmaceuticals Inc, 19462 - Plymouth Meeting/US
  • 6 Immunology, Inovio Pharmaceuticals, Inc., 19462 - Plymouth Meeting/US
  • 7 Biostatistics, Inovio Pharmaceuticals, Inc., 19462 - Plymouth Meeting/US
  • 8 Clinical, Inovio Pharmaceuticals, Inc., 19462 - Plymouth Meeting/US
  • 9 Medical Oncology, Weill Cornell Medical College, 10065 - New York/US
  • 10 Medical Oncology, University of Pittsburgh Cancer Institute, 15232 - Pittsburgh/US
  • 11 Medical Oncology, Chesapeake Urology Associates, 21204 - Towson/US
  • 12 Medical Oncology, Cleveland Clinic, 44195 - Cleveland/US
  • 13 Medical Oncology, Lineberger Comprehensive Cancer Center, 27599 - Chapel Hill/US
  • 14 Medicine, Thomas Jefferson University, philadelphia/US
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Resources

Abstract 5905

Background

INO-5150 (PSA and PSMA) +/- INO-9012 (IL-12), a synthetic DNA immunotherapy, was assessed for safety, immunogenicity and efficacy in biochemically recurrent prostate cancer patients (pts).

Methods

Phase I, open-label, multi-center study in the US included pts with rising PSA after surgery and/or RT, PSA doubling time (PSADT) >3 months (mos), testosterone >150 ng/dL and no concurrent ADT. Safety, immunogenicity and efficacy (PSA kinetics, PFS) were evaluated in 4 treatment arms of 15 pts each. Arms A: 2mg INO-5150, B: 8.5 mg INO-5150, C: 2mg INO-5150 + 1mg INO-9012 and D: 8.5mg INO-5150 + 1mg INO-9012. Pts received 4 IM doses of vaccine followed by electroporation on day 0, wks 3, 12 and 24 and were followed for 72 wks.

Results

50/61 (82%) pts completed all visits and treatments were well tolerated with no safety concerns. Median PFS for overall population [N = 61, baseline (D0) PSADT range (mos) 1.5-217.1, median 9.8] and for a subset of pts with D0 PSADT ≤12mos (N = 36) has not yet been reached (FU 3-19 mos). 86% of pts with D0 PSADT ≤12 mos were progression free through 19mos FU. 27 out of 36 (75%) pts with D0 PSADT≤ 12 mos had disease stabilization at wks 27 evidenced by significant improvement in log2PSA change over time (slope) and PSADT from D0 (Slope=0.19 declined to 0.1, PSADT=5.3 improved to 10.1 mos, p = <0.0001). This effect was maintained at wk 72 (Slope=0.09, PSADT=10.6, p = <0.0001). Immunogenicity was observed in 77% (47/61) of pts by multiple immunologic assessments. Patient immunogenicity to INO-5150 as determined by CD38 and Perforin + CD8 T cell immune reactivity correlated with attenuated % PSA rise compared to pts without reactivity (p = 0.05, n = 50).

Conclusions

INO-5150 +/- INO-9012 was safe, well tolerated and immunogenic. Clinical efficacy was observed in the patients with D0 PSADT≤ 12 mos as evidenced by a significant dampening of log2PSA change over time and increased PSADT up to 72 weeks FU. Additional genomic analyses are ongoing to further elucidate the correlation of immunologic efficacy and clinical benefit. (NCT02514213).

Clinical trial identification

FDA IND number 15870.

Legal entity responsible for the study

Inovio Pharmaceuticals, Inc.

Funding

Inovio Pharmaceuticals, Inc.

Editorial Acknowledgement

Disclosure

N. Shore: Consulting or advisory role for multiple pharmaceutical companies. E.I. Heath: Consulting or advisory role and honoraria or funding received for multiple pharmaceutical companies. H. Cheng, Y. Whang: Funding received from multiple pharmaceutical companies. K. Bhatt, M. Morrow, T. McMullan, K. Kraynyak, J. Lee, B. Sacchetta, L. Liu, S. Rosencranz, I. Csiki, M.L. Bagarazzi: Employee of the pharmaceutical company sponsoring this research trial. S.T. Tagawa, R. Tutrone, J. Garcia, W. Kelly: Consulting or advisory role and funding received from multiple pharmaceutical companies. All other authors have declared no conflicts of interest.

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