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  P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

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    P3.01-001 - Imprime PGG, a Novel Innate Immune Modulator, Combined with Carboplatin, Paclitaxel and Bevacizumab for 1st Line Advanced Nonsquamous NSCLC (ID 3005)

    09:30 - 09:30  |  Author(s): M.A. Gargano
    • Abstract
    • Slides

    Background:
    Imprime PGG (PGG) in combination with carboplatin/paclitaxel chemotherapy (C/P) and bevacizumab (Bev) increased objective response rates (ORR) and overall survival (OS) of patients (pts) with previously untreated stage IV non-squamous NSCLC in comparison to C/P + Bev alone in a randomized, controlled, multicenter phase 2 trial (Engel-Riedel W et al, Ann Oncol 25 [Suppl 5], 2014, LBA32). Herein, we report landmark survival analyses at the 1- and 2-year time points. The trial was sponsored by Biothera, ClinicalTrials.gov NCT 00874107, EudraCT 2008-006780-37.
    
    Methods:
    92 pts with stage IV nonsquamous NSCLC were randomized 2:1 to receive PGG (4 mg/kg IV days 1, 8, 15 of each 3-week cycle) + C/P + Bev (PGG group) vs C/P + Bev alone (Ctrl group). C/P was administered for 4 to 6 cycles; Bev +/- PGG were administered until disease progression or intolerable toxicity. The primary endpoint was ORR based on modified RECIST v1.0 and was assessed centrally. Secondary endpoints included overall survival (OS), progression-free survival (PFS), duration of response (DoR) and safety. Imaging assessments (CT of chest and abdomen) were reviewed every 6 weeks. The primary analysis occurred after all pts had either progressed or had the opportunity to complete at least 18 treatment cycles (54 weeks).
    
    Results:
    An objective response was 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). Median (m) OS was 16.1 mos with PGG compared to 11.6 mos (HR=0.66; p=0.13) with Ctrl. The mPFS was 11.9 mos vs 10.2 mos (HR=0.86; p=0.59), and mDoR was 10.3 mos vs 5.6 mos (HR=0.92; p=0.90) among subjects receiving PGG vs Ctrl, respectively. Survival rates of pts (95% CI) in the PGG vs Ctrl groups were 62.8% (48.8, 74.0) vs 42.7% (22.7, 61.4) at 12 mos, and 37.0% (22.5, 51.5) vs 24.4% (7.9, 45.7) at 24 mos. Overall, the incidence of adverse events (AEs) was 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.
    
    Conclusion:
    The addition of PGG to C/P + Bev therapy was well tolerated and resulted in clinically meaningful increases in ORR, DoR, and OS. Results did not reach statistical significance in this phase 2 study. Further investigation is warranted to confirm the efficacy and safety of this combination.
    
    

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