*FDA-approved anti–PD-1 therapy of the treating physician’s choosing.
DCR, disease control rate; DOR, duration of response; DRR, durable radiographic response; DSMB, data safety monitoring committee; ORR, overall response rate; OS, overall survival; PD, progressive disease; SD, stable disease; TILs, tumor-infiltrating lymphocytes.
†Blood and tissue from injected/noninjected lesions and draining lymph nodes will be collected throughout study for translational analyses..
‡Lerapolturev administered at a dose up to 6x108 TCID50 into up to 6 lesions q3w or q4w.
§IV pembrolizumab q3w or q6w or IV nivolumab q2w or q4w at discretion of the principal investigator.
LUMINOS-102 (NCT04577807) is a multicenter, open-label, randomized phase 2 study investigating the efficacy and safety of lerapolturev with or without anti–PD-1 antibodies in patients with unresectable cutaneous melanoma with injectable lesions who failed prior anti–PD-1 therapy.
The study enrolled its first patient in March 2021 and is currently ongoing at >12 US sites.
A completed safety run-in and interim analysis cleared the way for an increased dose. The maximum lerapolturev dose was increased to 1.6 x 109 TCID50 across a maximum of 6 lesions. The schedule of administration is now weekly for 7 weeks (induction) followed by dosing every 3 or 4 weeks (maintenance). This change demonstrated clinical benefit in 5 of 7 subjects treated with the new regimen as of October 1, 2022 and is summarized in a poster (below) presented at the Society for Melanoma Research (SMR) October 17-20, 2022.
LUMINOS-102 builds on the successful experience with lerapolturev in a previous phase 1 trial as published in the Journal for ImmunoTherapy of Cancer.