- 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.
- 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.
- 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).
- Median OS not reached.
- 2 grade 5 adverse events due to pulmonary embolism, acute myocardial infarction—cardiac toxicity?