Iván Márquez Rodas, MD, PhD, discusses the preliminary results of the phase 2 SPOTLIGHT203 trial, which is evaluating the efficacy and safety of BO-112 plus pembrolizumab in patients with advanced melanoma.
Iván Márquez Rodas, MD, PhD, coordinator, Heredofamilial Cancer Unit, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, Madrid, Spain, discusses the preliminary results of the phase 2 SPOTLIGHT203 trial (NCT04570332), which is evaluating the efficacy and safety of BO-112 plus pembrolizumab (Keytruda) in patients with advanced melanoma.
BO-112 is a double-stranded synthetic RNA formulated with polyethyleneimine that is being evaluated in combination with pembrolizumab for patients with unresectable stage III or IV melanoma with confirmed progression on PD-1/PD-L1 inhibitors.
The preliminary results of the SPOTLIGHT203 study, which were presented during the 2021 SITC Annual Meeting, demonstrated an objective response rate of 27% among 37 evaluable patients, meeting the primary end point of the study. At a median follow-up of 3 months, the disease-control rate was 64.9%.
Regarding safety, 88.1% of patients had at least 1 adverse effect (AE), 19% of which were grade 3 or 5. The most common toxicities included asthenia, pyrexia, diarrhea, vomiting, and chills. Notably, no patients required treatment discontinuation because of a therapy-related AE, Márquez Rodas concludes.