112P - Efficacy and safety of imprime PGG, a novel innate immune modulator, in combination with bevacizumab (Bev), carboplatin and paclitaxel for the 1st-l...

Date 17 April 2015
Event ELCC 2015
Session Poster lunch
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Cancer Immunology and Immunotherapy
Presenter Ada Braun
Citation Annals of Oncology (2015) 26 (suppl_1): 29-44. 10.1093/annonc/mdv050
Authors A. Braun1, W. Engel-Riedel2, F. Schneller3, M. Wolf4, W. Schuette5, J. Lowe1, P. Mattson1, M. Gargano1, M. Patchen1, R. Huhn1
  • 1Pharmaceutical Group, Biothera, 55121 - Eagan/US
  • 2Lungenklinik, Krankenhaus Merheim, 51109 - Köln/DE
  • 3Iii. Medizinische Klinik, Rechts der Isar Hospital,TUM, München/DE
  • 4Klinik Für Onkologie Und Hämatologie, Klinik Kassel, Kassel/DE
  • 5Clinic Of Internal Medicine Ii, Hospital Martha-Maria Halle-Dölau, Halle/Saale/DE



Imprime PGG (PGG) in combination with carboplatin/paclitaxel chemotherapy (C/P) and an EGFR-targeted antibody (cetuximab; Cet) increased objective response rates (ORR) compared to C/P + Cet alone (Schneller et al, J Thorac Oncol 2014; Vol 9 [Suppl 14], S40). This identically designed phase 2 trial evaluated PGG in combination with C/P and Bev in patients (pts) with stage IV non-squamous (no-sq) NSCLC.


Pts were randomized 2:1 to receive Bev + PGG (4 mg/kg IV weekly) or Bev (Ctrl) in combination with C/P for 4 to 6 cycles. Bev + PGG were administered until documented progression or intolerable toxicity. ORR was the primary endpoint; secondary endpoints included duration of response (DoR), overall survival (OS) and safety. Imaging assessments (6-weekly CT of chest and abdomen) were reviewed centrally. At the time of the primary analysis, all pts had either progressed or had the opportunity to complete at least 18 treatment cycles.


Objective responses were achieved by 29 out of 48 evaluable pts (60.4%; 1 CR, 28 PR) in the PGG group and 10 out of 23 (43.5%; 0 CR, 10 PR) in the Ctrl group (p = 0.21). There was continued regression of lesions on maintenance PGG + Bev. Median (m) DoR was 10.3 mos with PGG compared to 5.6 mos with Ctrl. mPFS was 11.9 mos versus 10.2 mos (HR = 0.84; p = 0.54), and mOS 16.1 mos versus 11.6 mos (HR = 0.66; p = 0.13) among subjects receiving PGG versus Ctrl, respectively. Overall incidences of adverse events (AEs) were similar across treatment groups. The most common AEs (occurring in ≥ 5 pts) deemed possibly or probably related to PGG by the investigator were chills (13.6%); dyspnea, fatigue (10.2% each); nausea, pyrexia, and infusion-related reactions (8.5% each). Overall, 37.3% of pts receiving PGG and 43.3% receiving Ctrl discontinued the study due to AEs.


The combination of PGG with Bev and C/P chemotherapy resulted in numerically increased ORR, DoR, PFS and OS in pts with stage IV no-sq NSCLC. These results warrant further investigation of PGG in phase 3. The trial was sponsored by Biothera.

Clinical trial identification NCT 00874107, EudraCT 2008-006780-37


A. Braun, J. Lowe, P. Mattson, M. Gargano and M. Patchen: full-time employee of Biothera, Inc. stock options and/or grants of the company.

All other authors have declared no conflicts of interest.