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    DRUG:

    Akalux (cetuximab sarotalocan)

    i
    Other names: ASP-1929, RM-1929, ASP 1929
    Company:
    Orient Europharma, Rakuten Medical
    Drug class:
    EGFR-targeted-dye conjugate
    3ms
    Safety and Efficacy Findings From a Phase Ib/II Study of ASP-1929 Photoimmunotherapy With Pembrolizumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. (PubMed, Head Neck)
    ASP-1929 photoimmunotherapy plus pembrolizumab was generally tolerable, with promising efficacy in patients with recurrent/metastatic HNSCC.
    P1/2 data • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)
    5ms
    Severe drug-induced interstitial lung disease after photoimmunotherapy with cetuximab-sarotalocan sodium in a patient with oropharyngeal cancer: A case report. (PubMed, Respir Med Case Rep)
    He received two cycles of intravenous methylprednisolone (1 g/day, 3 days/cycle) followed by oral prednisolone at 1 mg/kg/day, which was gradually tapered. Because cetuximab is a component of CS, CS-PIT has the potential to induce DIILD. Risk assessments and monitoring for DIILD are recommended for patients receiving CS-PIT.
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Erbitux (cetuximab) • Akalux (cetuximab sarotalocan) • methylprednisolone sodium succinate
    5ms
    Near-infrared photoimmunotherapy for recurrent cancer at the base of the tongue. (PubMed, Photodiagnosis Photodyn Ther)
    In NIR-PIT, administration of cetuximab sarotalocan sodium is followed by laser irradiation of the affected area, which theoretically should induce tumor cell death. EGFR expression was positive in all cases and expression score showed no significant change between before and after treatment. These findings suggest that puncture interval plays a critical role in therapeutic outcomes, whereas EGFR expression may not directly influence treatment efficacy.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)
    6ms
    Evaluation of real-time pharmacokinetics using fluorescence imaging system in Near-infrared photoimmunotherapy for head and neck cancer. (PubMed, Auris Nasus Larynx)
    We observed and measured the drug accumulation and responses during treatment in humans using real-time fluorescence imaging. This information is expected to be applied to evaluate efficacy of NIR-PIT.
    PK/PD data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)
    7ms
    Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Roswell Park Cancer Institute | Initiation date: May 2025 --> Sep 2025
    Trial initiation date
    |
    Erbitux (cetuximab) • Libtayo (cemiplimab-rwlc) • Akalux (cetuximab sarotalocan)
    7ms
    A phase Ib study of photoimmunotherapy with ASP-1929 in combination with nivolumab for advanced gastric cancer (GE-PIT, EPOC1901). (PubMed, Gastric Cancer)
    This study demonstrated that combining endoscopic photoimmunotherapy with nivolumab is safe and feasible for advanced gastric cancer.
    P1 data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR positive
    |
    Opdivo (nivolumab) • Erbitux (cetuximab) • Akalux (cetuximab sarotalocan)
    7ms
    Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=27, Not yet recruiting, Roswell Park Cancer Institute
    New P2 trial
    |
    Erbitux (cetuximab) • Libtayo (cemiplimab-rwlc) • Akalux (cetuximab sarotalocan)
    10ms
    An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination with Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=23, Active, not recruiting, Rakuten Medical, Inc. | N=74 --> 23 | Trial completion date: Jun 2025 --> Jun 2027 | Trial primary completion date: Jun 2024 --> Jun 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc) • Akalux (cetuximab sarotalocan)
    11ms
    ASP-1929-301: 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=135, Active, not recruiting, Rakuten Medical, Inc. | N=275 --> 135 | Recruiting --> Active, not recruiting
    Enrollment closed • Enrollment change
    |
    Erbitux (cetuximab) • paclitaxel • docetaxel • Akalux (cetuximab sarotalocan)
    11ms
    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, Recruiting, Rakuten Medical, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • cisplatin • carboplatin • paclitaxel • docetaxel • 5-fluorouracil • Akalux (cetuximab sarotalocan)
    1year
    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)
    1year
    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)