FOR PATIENTS
Clinical Trials

GLIOBLASTOMA
(LUMINOS-101)

Lerapolturev (formerly PVSRIPO) and pembrolizumab in
patients with recurrent glioblastoma

Lerapolturev (formerly PVSRIPO) and pembrolizumab in patients with recurrent glioblastoma

LUMINOS-101 Study Design

Study design of LUMINOS-101
  1. *Bevacizumab (7.5 mg/kg q3w) and/or dexamethasone (≤4 mg/day) for symptom control related to peritumoral edema, as needed.

  2. Patients receive IPOL® (poliovirus vaccine, inactivated) anti-poliovirus booster vaccination.

  3. Lerapolturev intratumoral administration of 5x107 tissue culture infectious dose (TCID50) via convection-enhanced delivery.

  4. §Lerapolturev retreatment if confirmed progressive disease (cPD) ≥12 months after prior infusion.

  5. For up to 24 months, permanent discontinuation for toxicity or cPD.

LUMINOS-101 Study Design

Study design of LUMINOS-101
  1. *Bevacizumab (7.5 mg/kg q3w) and/or dexamethasone (≤4 mg/day) for symptom control related to peritumoral edema, as needed.

  2. Patients receive IPOL® (poliovirus vaccine, inactivated) anti-poliovirus booster vaccination.

  3. Lerapolturev intratumoral administration of 5x107 tissue culture infectious dose (TCID50) via convection-enhanced delivery.

  4. §Lerapolturev retreatment if confirmed progressive disease (cPD) ≥12 months after prior infusion.

  5. For up to 24 months, permanent discontinuation for toxicity or cPD.

LUMINOS-101 (NCT04479241) is a multicenter, single-arm, phase 2 clinical study investigating the safety and efficacy of lerapolturev in combination with pembrolizumab in recurrent glioblastoma (rGBM). The study enrolled 25 patients across 10 US sites. The study showed that the combination of lerapolturev and pembrolizumab was well tolerated. Patients are currently being followed for landmark survival endpoints.

LUMINOS-101 builds on the successful experience with lerapolturev in a previous phase 1 monotherapy trial as published in the New England Journal of Medicine. More than 200 patients with GBM have now been treated with lerapolturev in phase 1 and phase 2 trials.

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  1. IPOL is a registered trademark of Sanofi Pasteur, SA.