1071P - Chemoimmunotherapy of advanced non-small cell lung cancer (NSCLC) with imprime PGG (IPGG) in combination with cetuximab, carboplatin and paclitaxel...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Cancer Immunology and Immunotherapy
Presenter Folker Schneller
Citation Annals of Oncology (2014) 25 (suppl_4): iv361-iv372. 10.1093/annonc/mdu342
Authors F. Schneller1, M. Thomas2, P. Sadjadian3, J. Kollmeier4, N. Bose5, M.L. Patchen5, J. Lowe5, P. Mattson5, M. Gargano5, R.D. Huhn5, A. Braun5
  • 1Medical Clinic, Rechts der Isar Hospital,TUM, 81675 - Munich/DE
  • 2Int. Oncology Of Thoraxtumor, Thoraxklinik Heidelberg, Heidelberg/DE
  • 3Onkologie Und H, Johannes Weseling klinikum, DE-32429 - Minden/DE
  • 4Oncology/pneumology, Helios Clinic Emil von Behring, 14165 - Berlin/DE
  • 5Pharma Clinical Research, Biothera, Inc., 55121 - Eagan/US

Abstract

Aim

IPGG is a yeast-derived ß-glucan that primes innate immune cells to kill monoclonal antibody-targeted cancer cells via complement receptor 3 (CR3). Subjects with anti-beta glucan antibodies (ABA) levels conducive to IPGG binding to CR3 are considered “biomarker positive” (BM+). We have previously reported significant improvements in objective responses with IPGG in combination with cetuximab, carboplatin and paclitaxel in patients (pts) with advanced NSCLC. Herein, we present the secondary endpoints of the clinical trial.

Methods

Pts with Stage IV NSCLC received cetuximab (CET) 250 mg/m2 following initial 400 mg/m2 loading dose) without (Control, N = 30) or with IPGG 4mg/kg (IPGG, N = 60) on Days 1, 8 and 15 of each 3-week treatment cycle, and carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2 for the first 4 to 6 cycles. Pts achieving radiographic stable disease or tumor response (modified RECIST 1.0) received CET or CET/IPGG maintenance treatment. The primary endpoint was objective response rate. Secondary endpoints included disease control rate (DCR: CR + PR + SD), time to progression (TTP), overall survival (OS) and safety.

Results

Best overall response (control vs IPGG) was PR in 23.1% vs 47.8% (p = 0.048), SD in 53.8% vs 30.4%, and PD in 23.1% vs 21.7%, respectively; DCR was 76.9% vs 78.3%, respectively (p = NS). ORR was 66.7% with IPGG in BM+ pts (p = 0.009 vs. Control) and 38.7% in the BM - group (p = NS vs. Control). Median TTP was 4.4 mo vs 4.3 mo respectively in the overall population and 5.6 mo in BM+ pts receiving IPGG (p = NS). OS was 11.3 mo vs 12.4 mo overall (p = NS), and 16.7 mo in BM+ pts vs. 9.4 mo in BM- pts receiving IPGG (p = 0.133). All subjects had at least one adverse event; grade III/IV adverse events occurred in 86.2% vs 78.0% of control vs. IPGG-treated pts.

Conclusions

In patients with stage IV NSCLC receiving combination therapy with carboplatin, paclitaxel and CET, IPGG was well tolerated, improved objective responses and prolonged OS in BM+ pts.

Disclosure

N. Bose, M.L. Patchen, J. Lowe, P. Mattson, M. Gargano, R.D. Huhn and A. Braun: Employee of Biothera, Inc.All other authors have declared no conflicts of interest.