Dr. Márquez Rodas on the Preliminary Efficacy of BO-112/Pembrolizumab in 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.