Virtual Library

Start Your Search

Erminia Massarelli



Author of

  • +

    FP03 - Immuno-biology and Novel Immunotherapeutics (Phase I and Translational) (ID 151)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Immuno-biology and Novel Immunotherapeutics (Phase I and Translational)
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
    • +

      FP03.05 - TLR9 Agonist CMP-001 Plus Atezolizumab +/- Radiation Therapy in Patients With PD-1 Blockade Resistant Advanced NSCLC (ID 3571)

      00:00 - 00:00  |  Author(s): Erminia Massarelli

      • Abstract
      • Presentation
      • Slides

      Introduction

      Patients with non–small cell lung cancer (NSCLC) and progressive disease (PD) following programmed death 1 (PD-1) blockade therapy have a poor prognosis. CMP-001 is a CpG-A Toll-like receptor 9 (TLR9) agonist packaged within a virus-like particle. The multicenter, open-label, 2-part, Phase 1b CMP-001-003 study (NCT03438318) evaluated the safety and preliminary antitumor activity of CMP-001 plus atezolizumab with or without radiation in patients with advanced NSCLC.

      Methods

      Eligible patients with PD following anti–PD-1/programmed death ligand 1 (PD-L1) therapy and ≥1 extra-central nervous system, non-bone metastasis amenable for intratumoral injection received CMP-001 and atezolizumab (Part A) or CMP-001, atezolizumab, and radiation (Part B). CMP-001 was administered at 5 mg subcutaneously once weekly during weeks 1 and 2, followed by 5 mg or 10 mg intratumorally once weekly during weeks 3-5 and every 3 weeks thereafter. Atezolizumab 1200 mg was administered intravenously once every 3 weeks starting on week 2. Radiation therapy in Part B consisted of 20 Gy delivered in 5 fractions starting ≥2 days prior to CMP-001 treatment. Following a safety run-in period (n=5), each Part enrolled additional patients in Stage 1; ≥2 of 12 patients were required to have a RECIST v1.1 response to proceed with Stage 2 enrollment. The primary objective was to evaluate the safety of CMP-001 and atezolizumab with or without radiation. A key secondary endpoint was best objective response per RECIST v1.1 as assessed by the investigator.

      Results

      Twenty-nine patients were enrolled in Stage 1 (Part A, n=13; Part B, n=16). The median number of prior lines of therapy received was 3 (range, 1-6); 31.0% of patients had ≥4 prior lines of therapy. Only 5 patients (17.2%) had response to any prior systemic therapy. The median number of CMP-001 intratumoral injections was 3 (Part A range, 1-12; Part B range, 1-6); 12 patients had a total of 65 injections into visceral lesions, including kidney, liver, lung, and pleura, which were safely performed. The most common treatment-related adverse events (TRAEs; ≥30%) overall were flu-like symptoms (ie, chills and pyrexia) and hypotension. Six patients (46.2%) in Part A and 8 patients (50.0%) in Part B had grade ≥3 TRAEs. Only 1 patient discontinued treatment due to TRAEs (Part A, grade 3 pneumonitis). As of April 15, 2020 (Part A median follow-up, 1.9 months [range, 1-19]; Part B median follow-up, 1.7 months [range, 1-4]), no objective responses were observed. Two patients (15.4%) and 4 patients (25.0%) had tumor shrinkage (<30% decrease in tumor size) in Parts A and B, respectively. Three patients (23.1%) and 8 patients (50.0%) had stable disease as best response in Parts A and B, respectively. Study enrollment was stopped after completion of Stage 1 due to lack of objective response. The cytokine response to CMP-001 treatment and tissue biopsy analyses will be presented.

      Conclusion

      CMP-001 plus atezolizumab with and without radiation therapy had a manageable safety profile. Intratumoral injection of CMP-001 into visceral lesions was safely achieved, and stable disease was observed in heavily pretreated patients with PD-1/PD-L1 refractory NSCLC.

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.