Akalux (cetuximab sarotalocan)

P2, N=16, Terminated, Rakuten Medical, Inc. | Active, not recruiting --> Terminated; Business decision

P2, N=22, Recruiting, Rakuten Medical, Inc. | Trial completion date: Sep 2025 --> Mar 2027

In September 2020, the Japanese government approved cetuximab saratolacan (previously known as RM-1929, commercial name: Akalux) for the treatment of unresectable locally advanced or recurrent head and neck cancer. The treatment consists in the intravenous injection of cetuximab saratolacan, which binds to head and neck cancer cells expressing high levels of EGFR, followed by illumination of the tumor with red light (690 nm) for photodynamic therapy. This approach causes immunogenic cell death in malignant tissues, thus triggering a potent anticancer immune response.

Background RM-1929 is an antibody-dye conjugate comprised of cetuximab covalently linked to the photoactivable dye, IRDye® 700DX (IR700). Conclusions These results suggest that rHNSCC patients with lower PD-L1 expression levels may be more responsive to RM-1929 treatment and CPS/TPS could potentially be predictive biomarkers in identifying patients with a higher probability of benefiting from this treatment. Given the limited number of patients in this analysis, additional clinical trials will be needed to validate PD-L1 expression as an effective predictive biomarker for RM-1929 treatment.

Background RM-1929 is an antibody-dye conjugate comprised of cetuximab covalently linked to the photoactivable dye, IRDye® 700DX (IR700). Conclusions These results suggest that rHNSCC patients with lower PD-L1 expression levels may be more responsive to RM-1929 treatment and CPS/TPS could potentially be predictive biomarkers in identifying patients with a higher probability of benefiting from this treatment. Given the limited number of patients in this analysis, additional clinical trials will be needed to validate PD-L1 expression as an effective predictive biomarker for RM-1929 treatment.