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Pembrolizumab + temozolomide + Optune is a combination regimen currently in Phase 3 clinical development (EF-41/KEYNOTE D58) for the treatment of newly diagnosed glioblastoma. The regimen combines the immune checkpoint inhibitor pembrolizumab (Keytruda), which targets the PD-1 receptor on T-cells, with the standard-of-care chemotherapy temozolomide and NovoCure's Optune device. Optune delivers Tumor Treating Fields (TTFields), which are low-intensity, alternating electric fields tuned to 200 kHz to interfere with the division of glioblastoma cells by disrupting mitotic spindle assembly. This multi-modal approach aims to improve overall survival by simultaneously stimulating the immune system, inducing DNA damage, and physically inhibiting cell replication.
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