SOLTI-1503 PROMETEO TRIAL: combination of talimogene laherparepvec with atezolizumab in early breast cancer.

Pascual, Tomas; Cejalvo, Juan M; Oliveira, Mafalda; Vidal, Maria; Vega, Estela; Ganau, Sergi; Julve, Ana; Zamora, Esther; Miranda, Ignacio; Delgado, Ana; Bermejo, Begoña; la Cruz-Merino, Luis de; Juan, Manel; Ferrero-Cafiero, Juan M; Canes, Jordi; Gonzalez, Xavier; Villagrasa, Patricia; Prat, Aleix

New treatment strategies such as immune checkpoint inhibitors and oncolytic viruses are opening new possibilities in cancer therapy. Preliminary results in melanoma and other tumors showed that the combination of talimogene laherparepvec with an anti-PD-1/PD-L1 or anti-CTLA4 has greater efficacy than either therapy alone, without additional safety concerns beyond those expected for each agent. The presence of residual cancer after neoadjuvant chemotherapy in early breast cancer patients is an unmet medical need. SOLTI-1503 PROMETEO is a window of opportunity trial, which evaluates the combination of talimogene laherparepvec in combination with atezolizumab in women with operable HER2-negative breast cancer who present residual disease after neoadjuvant chemotherapy. The primary end point is the rate of residual cancer burden 0/1. Clinical Trial Registration: NCT03802604 (ClinicalTrials.gov).