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Anti-mesothelin vaccine CRS-207 with or without low-dose cyclophosphamide plus chemotherapy as front-line treatment for malignant pleural mesothelioma (MPM)
  1. Raffit Hassan1,
  2. Evan Alley2,
  3. Hedy Kindler3,
  4. Scott Antonia4,
  5. Thierry Jahan5,
  6. Anish Thomas1,
  7. Somayeh Honarmand6,
  8. Aimee L Murphy6,
  9. John J Grous7 and
  10. Dirk G Brockstedt6
  1. Aff1 grid.417768.b0000000404839129Center for Cancer Research at the National Institutes of Health Bethesda MD USA
  2. Aff2 grid.25879.310000000419368972University of Pennsylvania Philadelphia PA USA
  3. Aff3 grid.170205.10000000419367822The University of Chicago Medicine Chicago IL USA
  4. Aff4 grid.170693.a000000012353285XH. Lee Moffitt Cancer Center and Research Institute Tampa FL USA
  5. Aff5 grid.266102.10000000122976811University of California San Francisco San Francisco CA USA
  6. Aff6 grid.417411.6Aduro Biotech Inc. Berkeley CA USA
  7. Aff7 grid.417411.6Aduro Biotech Inc. Hopedale MA USA

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Meeting abstracts


CRS-207 is live-attenuated, double-deleted Listeria monocytogenes (LADD) engineered to express the tumor-associated antigen mesothelin which is highly expressed in malignant pleural mesothelioma (MPM). CRS-207 stimulates potent innate and adaptive immunity and in combination with chemotherapy may act synergistically to alter the tumor environment to be more susceptible to immune-mediated killing. Preliminary data of 32 patients who received CRS-207 in combination with pemetrexed/cisplatin showed 60% partial responses and 94% disease control[1]. Low-dose cyclophosphamide (Cy) in combination with LADD improved immune and anti-tumor responses and overall survival in preclinical studies.


Up to 60 subjects are planned to be enrolled in 2 mutually exclusive, sequential cohorts at 5 clinical trial sites. Patients must be chemotherapy-naïve, have unresectable MPM, good performance status (ECOG 0 or 1) and adequate organ function. Eligible patients in Cohort 1 receive 2 prime vaccinations with CRS-207 (1 × 109 CFU; 250 mL IV over 2 hours) 2 weeks apart, followed by up to 6 cycles of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) 3 weeks apart and 2 CRS-207 boost vaccinations 3 weeks apart. Subjects are followed every 8 weeks until disease progression. Clinically stable patients continue CRS-207 maintenance vaccinations every 8 weeks. Patients in Cohort 2 receive low-dose Cy (200 mg/m2) 1 day prior to each CRS-207 vaccination. Objectives of the study are safety, immunogenicity, objective tumor responses and tumor marker kinetics.


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