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Poster display session

2474 - Final Clinical 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 Nonsquamous Non Small Cell Lung Cancer

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Non-Small Cell Lung Cancer

Presenters

Ramon Palmero

Citation

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

Authors

R. Palmero1, P. Bidoli2, I.M. Bondarenko3, M. Boyer4, P. Germonpre5, D. Ghizdavescu6, A. Kotsakis7, H. Lena8, G. Losonczy9, K. Park10, M. Reck11, W. Su12, N. Kallinteris13, M. Tang13, J. Lai13, J. Shan13, D.R. Spigel14

Author affiliations

  • 1 Medical Oncology, Institut Català d'Oncologia Hospital Duran i Reynals, 08907 - Barcelona/ES
  • 2 Medical Oncology, Azienda Ospedaliera S. Gerardo U.O. Oncologia Medica, 20052 - Monza/IT
  • 3 Oncology, Dnipropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital, 49102 - Dnepropetrovsk/UA
  • 4 Medical Oncology, Chris O'Brien Lifehouse, 2050 - Camperdown/AU
  • 5 Medical Oncology, AZ Maria Middelares, 9000 - Gent/BE
  • 6 Medical Oncology, Municipal Hospital, 100337 - Ploiesti/RO
  • 7 Medical Oncology, University Hospital of Heraklion, 712 01 - Heraklion/GR
  • 8 Medical Oncology, CHU de Pontchaillou, 35033 - Rennes/FR
  • 9 Medical Oncology, Semmelweis University I. Faculty of Medicine, 1085 - Budapest/HU
  • 10 Division Of Heamatology/oncology, Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 11 Department Of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 12 Medical Oncology, National Cheng Kung University, 701 - Tainan/TW
  • 13 Clinical And Regulatory, Peregrine Pharmaceuticals, Inc., Tustin/US
  • 14 Medical Oncology, Sarah Cannon Research Institute/Tennessee Oncology, PLLC, 37203 - Nashville/US
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Resources

Abstract 2474

Background

Exposed phosphatidylserine (PS) in the tumor microenvironment is highly immunosuppressive. Bavituximab targets PS and repolarizes M2 macrophages to M1 resulting in production of pro-inflammatory cytokines such as IFN-γ and IL-12, maturation of dendritic cells, and tumor specific cytotoxic T lymphocyte immunity. In a prior blinded Phase II trial in 2nd-line nonsquamous NSCLC, bavituximab + docetaxel was well-tolerated and demonstrated 60% improvement (11.7 vs 7.3 months) in median overall survival (mOS) (HR, 0.66; P = 0.11) compared to control.

Methods

597 patients with Stage IIIb/IV nonsquamous NSCLC that progressed on platinum-doublet chemotherapy were randomized 1:1 to receive up to six 21-day cycles of docetaxel in combination with weekly 3 mg/kg bavituximab (B+D) or placebo (D) until progression or toxicity. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and safety.

Results

With 12 months follow-up from the last patient randomized and ∼85% of the targeted OS events reached, mOS was 10.5 months (95% confidence interval [CI], 8.4-11.9) among 297 patients in B+D and 10.9 months (95% CI, 9.2-12.1) among 300 patients in D (HR, 1.06; P = 0.533). PFS was 4.2 months (95% CI, 3.9-4.6) in B+D and 4.1 months (95% CI, 3.2-4.8) in D (HR, 1.02; P = 0.876). The ORR was 15% in B+D vs. 11% in D (odds ratio, 0.7; P = 0.15). The safety profile was similar between groups. Grade 3 or higher adverse events occurred in 68% of patients in B+D and 60% in D. In an exploratory analysis of OS for patients who received subsequent immune checkpoint inhibitors (ICI), the mOS was not reached (95% CI, 15.2-NA) in B+D (n = 46) and 12.6 months (95% CI, 10.4-17.8) in D (n = 47) (HR, 0.46; P = 0.006).

Conclusions

The combination of B+D was well-tolerated though no OS difference was observed compared to D alone in the ITT population of previously treated nonsquamous NSCLC. An exploratory analysis of patients who received subsequent ICI found significantly longer OS in patients who received prior B+D than those who received D and support further clinical investigation of B+ICI in NSCLC.

Clinical trial identification

NIH = NCT01999673 EudraCT = 2013-003953-13

Legal entity responsible for the study

Peregrine Pharmaceuticals Inc.

Funding

Peregrine Pharmaceuticals Inc.

Disclosure

P. Bidoli: Eli Lilly personal fees and advisory board BMS personal fees and advisory board Boehringer personal fees and advisory board. M. Reck: Honoraria for lectures and consultancy with Hoffmann-La Roche, Lilly, MSD, Merck, BMS, AstraZeneca, Celgene, Boehringer-Ingelheim, Pfizer, Novartis. N. Kallinteris, J. Lai: Peregrine Pharmaceuticals Inc. = employee, stock ownership M. Tang: Peregrine = Employee, stock owner. J. Shan: Employee, officer and stock owner for Peregrine Pharmaceuticals Inc. All other authors have declared no conflicts of interest.

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