8P - Safety of Imprime PGG, a novel innate immune modulator, in adults with stage IV non-small cell lung cancer (NSCLC)

Date 21 November 2014
Event ESMO Symposium on Immuno-Oncology 2014
Session Welcome reception and Poster viewing
Topics Non-Small-Cell Lung Cancer, Metastatic
Cancer Immunology and Immunotherapy
Presenter Michael Thomas
Authors M. Thomas1, F. Schneller2, P. Sadjadian3, Z. Hao4, P. Mattson5, J. Lowe5, R. Huhn5, A. Braun6, C. Taitt5
  • 1Thoracic Oncology, Thoraxklinik at Heidelberg University, 69126 - Heidelberg/DE
  • 2Hematology/oncology, Medical Clinical Technical University of Munich, 81675 - Munich/DE
  • 3Onkologie Und Hämatologie, Johannes Weseling Klinikum, Minden/DE
  • 4Thoracic Oncology, MCGHealth Cancer Center, Augusta/US
  • 5Pharmaceutical Group, Biothera, Eagan/US
  • 6Pharmaceutical Group, Biothera, 55121 - Eagan/US

Abstract

Body

Background: Imprime PGG (IPGG; beta-1,3/1,6 glucan), a yeast-derived pathogen-associated molecular pattern (PAMP) primes innate immune cells to kill cancer cells opsonized by therapeutic antibodies. Recent results from an open-label randomized phase 2 trial in the frontline treatment of stage IV NSCLC showed significantly improved objective response rates (ORR; 48% vs 23%) with the addition of IPGG to backbone treatment with carboplatin, paclitaxel (C,P) and cetuximab (cet) versus same backbone treatment alone. Unplanned analyses by anti-beta glucan antibody (ABA) status, an independently established biomarker indicative of an individual's ability to respond to IPGG, showed further improved ORR (67%) and a trend towards improved survival (HR = 0.70; p = NS) with IPGG. Here we report for the first time detailed safety analyses from that trial.

Results: A total of 88 patients (pts) were enrolled (59 IPGG, 29 control [ctl]) and evaluable for safety. All pts experienced at least 1 treatment-emergent adverse event (AE) over the course of the study. Grade (Gr) III/IV AEs occurred in 78.0 and 86.2% of pts, and serious AEs in 62.7 and 41.4%, respectively. Most common Gr III/IV AEs (occurring in at least 10% of pts) included neutropenia (32.2%, 48.3%), leukopenia (15.3%, 31%), and rash (3.4%, 10.3%). In the IPGG arm, 52.5% pts experienced Gr III/IV AEs reported as unlikely, possibly, or probably related to IPGG. Grade III/IV AEs related to cet were experienced by 55.9% pts in the IPGG group and 69.0% in the ctl group, and Gr III/IV AEs related to C,P by 66.1% and 65.5%, respectively. Two subjects in the IPGG group (neutropenia, sepsis and acute renal failure considered unlikely related to IPGG; pleural effusion considered unrelated to IPGG in 1 pt each) and 0 in the ctl group died due to AEs. Results by biomarker subsets will be presented.

Conclusions: IPGG was generally well tolerated in pts with stage IV NSCLC receiving C,P and cet therapy frontline.