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    DRUG:

    Akalux (cetuximab sarotalocan)

    i
    Other names: ASP-1929, RM-1929, ASP 1929
    Company:
    Rakuten Medical
    Drug class:
    EGFR-targeted-dye conjugate
    1m
    ECLIPSE: A Study of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck with No Distant Metastases (clinicaltrials.gov)
    P3, N=408, Not yet recruiting, Rakuten Medical, Inc.
    New P3 trial • Combination therapy
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • cisplatin • carboplatin • paclitaxel • docetaxel • 5-fluorouracil • Akalux (cetuximab sarotalocan)
    3ms
    ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed At Least Two Lines of Therapy (clinicaltrials.gov)
    P3, N=275, Recruiting, Rakuten Medical, Inc. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    Erbitux (cetuximab) • paclitaxel • docetaxel • Akalux (cetuximab sarotalocan)
    4ms
    ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer (clinicaltrials.gov)
    P2, N=9, Active, not recruiting, Rakuten Medical, Inc. | Recruiting --> Active, not recruiting | N=22 --> 9 | Trial completion date: Mar 2027 --> Jun 2026 | Trial primary completion date: Mar 2025 --> Jul 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    Akalux (cetuximab sarotalocan)
    8ms
    ASP-1929 Photoimmunotherapy Combined With Pembrolizumab in Patients With Recurrent Head and Neck Cancer, With or Without Metastases (clinicaltrials.gov)
    P2, N=16, Terminated, Rakuten Medical, Inc. | Active, not recruiting --> Terminated; Business decision
    Trial termination
    |
    Keytruda (pembrolizumab) • Akalux (cetuximab sarotalocan)
    8ms
    ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer (clinicaltrials.gov)
    P2, N=22, Recruiting, Rakuten Medical, Inc. | Trial completion date: Sep 2025 --> Mar 2027
    Trial completion date
    |
    Akalux (cetuximab sarotalocan)
    4years
    Regulatory approval of photoimmunotherapy: photodynamic therapy that induces immunogenic cell death. (PubMed, Oncoimmunology)
    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.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)
    4years
    [VIRTUAL] PD-L1 is a potential predictive biomarker for response to RM-1929 treatment in recurrent head and neck squamous cell carcinoma patients (SITC 2020)
    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.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)
    4years
    [VIRTUAL] PD-L1 is a potential predictive biomarker for response to RM-1929 treatment in recurrent head and neck squamous cell carcinoma patients (SITC 2020)
    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.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)