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  P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

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    P2.01-089 - A Phase 1b/2 Randomized Study of PEGPH20 in Combination with Docetaxel in Hyaluronan High NSCLC Patients Treated with Platinum Chemotherapy (ID 1705)

    09:30 - 09:30  |  Author(s): S. Shuey
    • Abstract
    • Slides

    Background:
    Patients with advanced non-small cell lung cancer (NSCLC) progressing after 1[st] line platinum containing doublet chemotherapy +/- targeted therapy for EGFR mutations and EML4-ALK fusion genes have limited therapeutic options. Extracellular components such as hyaluronan (HA) make up the tumor microenvironment (TME) and may limit access of chemotherapeutic agents to the cell as a result of increased interstitial pressure and decreased blood flow. PEGPH20 (PEG) decreases HA and restores blood flow. In animal models of NSCLC, PEG + docetaxel (Doc) significantly prolonged survival compared to Doc alone. These results are consistent with results in previous studies in pancreatic adenocarcinoma (PDA). In a Phase 1b trial of the combination of PEG + gemcitabine in Stage IV pts with PDA whose tumors were HA-high pts had higher ORR, PFS and OS compared to pts with HA-low tumors.
    
    Methods:
    This is an ongoing Phase 1b/2 open-label, randomized study of the addition of PEG to docetaxel (PDoc) compared to docetaxel (Doc) in pts with Stage IIIB/IV NSCLC having been treated with at least 1[st] line platinum containing chemotherapy. The Phase 1b portion of the study will determine the maximum tolerated dose (MTD), dose limiting toxicity and recommended Phase 2 dose for two schedules of PEG; one given every 21 days with Doc and the second dosed 2X per week with Doc. Up to 40 subjects are expected to be enrolled in the Phase 1b dose escalation. Once MTDs are determined the second portion of the Phase 1b will accrue approximately 10 patients whose tumors are HA-high to determine which schedule will go forward in Phase 2. The Phase 2 will randomize 188 patients in a 1:1 fashion to receive PDoc or Doc stratified by histology and prior targeted therapy. The primary endpoint of the Phase 2 portion is PFS. This is the first clinical trial evaluating PEGPH20 in NSCLC. The trial is currently accruing to the dose finding portion of the Phase 1b. ClinicalTrials.gov Identifier: NCT02346370
    
    Results:
    not applicable
    
    Conclusion:
    not applicable
    
    

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