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Top-line results from SUNRISE: A phase III, randomized, double-blind, placebo-controlled multicenter trial of bavituximab plus docetaxel in patients with previously treated stage IIIb/iv non-squamous non-small cell lung cancer

Date

10 Oct 2016

Session

NSCLC, metastatic 2

Presenters

David Spigel

Citation

Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435

Authors

D.R. Spigel1, I. Bondarenko2, G. Losonczy3, J. Mezger4, H. Kalofonos5, M. Reck6, R. Palmero7, T. Jang8, R. Natale9, R.E. Sanborn10, J. Lai11, N. Kallinteris12, M. Tang13, J. Shan14, D. Gerber15

Author affiliations

  • 1 Oncology, Sarah Cannon Research Institute-cancer centre, 37203 - Nashville/US
  • 2 Department Of Oncology, Radiodiagnosis And Radioth, Dnipropetrovsk Municipal Clinical Hospital #4, 49102 - Dnepropetrovsk/UA
  • 3 Pulmonológiai Klinika, Semmelweis Egyetem, Budapest/HU
  • 4 Oncology, St. Vincentius Hospital Medizinische Klinik II, Karlsruhe/DE
  • 5 Oncology, University Hospital Patras, Patras/GR
  • 6 Oncology, LungenClinic Grosshansdorf GmbH, Grosshansdorf/DE
  • 7 Oncology, Institut Català d'Oncologia Hospital Duran i Reynals, Barcelona/ES
  • 8 Oncology, Kosin Univeristy Gospel Hospital, Busan/KR
  • 9 Oncology, Cedars-Sinai Medical Center, Los Angeles/US
  • 10 Oncology, Providence Cancer Center, Portland/US
  • 11 Clinical Operations, Peregrine Pharmaceuticals, Inc., 14282 - Tustin/US
  • 12 Translational, Peregrine Pharmaceuticals, Inc., 14282 - Tustin/US
  • 13 Biostatistics, Peregrine Pharmaceuticals, Inc., 14282 - Tustin/US
  • 14 Clinical & Regulatory Affairs, Peregrine Pharmaceuticals, Inc., 92780 - Tustin/US
  • 15 Oncology, University of Texas Southwestern Medical Center at Dallas, Dallas/US
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Abstract 4589

Background

Exposed phosphatidylserine (PS) in the tumor microenvironment is highly immunosuppressive. Bavituximab targets PS in the presence of �2GP1 as a high affinity complex and repolarizes myeloid derived suppressor cells and M2 macrophages to M1, resulting in production of pro-inflammatory cytokines such as IFNγ and IL-12, maturation of dendritic cells and induction of tumor specific cytotoxic T lymphocyte immunity. In a prior double-blind Phase II trial in 2nd line non-squamous NSCLC, bavituximab 3 mg/kg plus docetaxel was well-tolerated and demonstrated 60% improvement (11.7 vs 7.3 month) in median overall survival (OS) compared to control.

Methods

We accrued 597 patients with Stage IIIb/IV non-squamous NSCLC who progressed on platinum-doublet chemotherapy in a 1:1 ratio to receive up to six 21-day cycles of docetaxel in combination with either weekly 3 mg/kg bavituximab (B + D) or placebo (D) until progression or toxicity. The primary endpoint was OS and secondary endpoints included progression-free survival, overall response rate and safety. Exploratory testing of immune correlatives is ongoing.

Results

With 70% of the targeted OS events reached, the median OS is 10.7 months (95% confidence interval [CI], 8.6-11.5) among 297 patients in the B + D group and 10.8 months (95% CI, 9.2-12.6) among 300 patients in the D group (hazard ratio for death, 1.11; P = 0.829). In patients with pretreatment �2GP1 levels of ≥ 200 µg/mL, the mOS is 11.9 months (95% CI, 9.0-14.7) in the B + D group and 9.4 months (95% CI, 7.7-11.7) patients in the D group (HR for death, 0.77; P = 0.1). The safety profile was generally similar between groups. Grade 3/4 febrile neutropenia was slightly higher for B +D (8.75%) than D (5.69%).

Conclusions

SUNRISE did not meet the primary objective of superior OS in patients with previously treated non-squamous NSCLC; however, in patients with high �2GP1, the addition of bavituximab to docetaxel demonstrated a trend for prolonged survival indicating selection of patients based on pretreatment �2GP1 is critical for bavituximab activity and should be included in future trials.

Clinical trial identification

PPHM 1202 - NCT01999673 (NIH) Release Date: November 25, 2013

Legal entity responsible for the study

Peregrine Pharmaceuticals Inc.

Funding

Peregrine Pharmaceuticals Inc.

Disclosure

M. Reck: Honoraria for lectures: Hoffmann-La Roche, Lill¥, Boehringer-Ingelheim, BMS, MSD, Pfizer, AstraZeneca, NOvartis, Celgene. Honoraria for consultancy: Hoffmann-La Roche, Lilly, Boehringer-Ingelheim, BMS, MSD, Pfizer, AstraZeneca, Novartis, Celgene. R.E. Sanborn: Peregrine advisory board. J. Lai, N. Kallinteris, M. Tang, J. Shan: Peregrine employee. D. Gerber: Peregrine corporate sponsored research funding. All other authors have declared no conflicts of interest.

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