Trial results for the LUMINOS-101 study (NCT04479241) investigating lerapolturev and pembrolizumab in patients with recurrent glioblastoma were posted on ClinicalTrials.gov on 2025-03-25. The study reported an Objective Response Rate (ORR) of 0 participants for the combination therapy.
Background
The LUMINOS-101 study investigated lerapolturev and pembrolizumab as a combination therapy for patients with recurrent glioblastoma, including supratentorial glioblastoma and other brain tumors.
Trial design
The LUMINOS-101 study (NCT04479241) was a Phase 2, single-arm trial that enrolled 25 participants. The study investigated lerapolturev intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every 3 weeks thereafter, in patients with recurrent glioblastoma. The trial aimed to characterize the efficacy, safety, and tolerability of this combination.
Key results
The trial results for the lerapolturev and pembrolizumab combination in patients with recurrent glioblastoma included several key measurements:
- The Objective Response Rate (ORR) was reported as 0 participants.
- The Disease Control Rate (DCR) was 4 percentage of participants (95% Confidence Interval).
- Median survival assessed by Kaplan-Meier methods was 10.2 months (95% Confidence Interval).
- The frequency and severity of treatment-emergent adverse events were assessed in 25 Participants.
What this means
The results from the LUMINOS-101 trial provide initial efficacy and safety data for the combination of lerapolturev and pembrolizumab in patients with recurrent glioblastoma. The reported Objective Response Rate of 0 participants and a Disease Control Rate of 4 percentage of participants suggest limited objective responses to this specific combination in the studied population. The median survival of 10.2 months offers a measure of patient outcome in this challenging disease setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04479241, titled "LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma," were posted on 2025-03-25 on clinicaltrials.gov.