ASCO-SITC 2019—Nivolumab + HS-110 vaccine shows safety, preliminary efficacy in advanced NSCLC


  • Melissa Pandika
  • Univadis
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Takeaway

  • Viagenpumatucel-L (HS-110) plus nivolumab was safe, and showed preliminary efficacy in advanced NSCLC.

Why this matters

  • Adding HS-110 to nivolumab may result in greater antitumor activity than nivolumab alone by triggering an increase in tumor-specific T-cells, and restore responsiveness in immune checkpoint inhibitor (ICI)-refractory NSCLC.

Study design

  • Analysis of initial 2 cohorts from HS-110+nivolumab arm in phase 1b/2 DURGA trial evaluating combination of HS-110+ICIs in patients with advanced NSCLC.
    • Patients with previously treated NSCLC received 1×107 HS-110 cells/week for first 18 weeks + nivolumab 3 mg/kg or 240 mg every 2 weeks until tumor progression/intolerable toxicity.
    • Cohort A patients were ICI-naive.
    • Cohort B patients had received prior ICI.
  • Primary objectives: Objective response rate (ORR), safety.
  • Funding: Heat Biologics.

Key results

  • Enrollment through 9/9/18
    • Cohort A: 42 patients
    • Cohort B: 20 patients.
  • Cohort A
    • ORR: 21.4% (95% CI, 10.3%-36.8%)
    • Median PFS: 2.6 months (95% CI, 1.8-8.0 months)
    • Occurrence of injection site reactions, increased IFN-γ ELISPOTS potentially associated with improved OS.
  • Cohort B
    • ORR: 15% (95% CI, 3.2%-37.9%)
    • Median PFS: 2.7 months (95% CI, 1.8-4.0 months).

Limitations

  • Median OS not reached.
  • 2 grade 5 adverse events due to pulmonary embolism, acute myocardial infarctioncardiac toxicity?

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