Announcement • 7h
Alpha Tau Medical Ltd. Successfully Treats First Immunocompromised Patient with Recurrent Cutaneous Squamous Cell Carcinoma in Its Admire Study At Banner Md Anderson Cancer Center
Alpha Tau Medical Ltd. issued a press release titled "Alpha Tau Successfully Treats First Immunocompromised Patient with Recurrent Cutaneous Squamous Cell Carcinoma in its ADMIRE Study at Banner MD Anderson Cancer Center in Gilbert, Arizona." The ADMIRE study, by treating immunocompromised patients, builds on the momentum of Alpha Tau's ReSTART pivotal trial for recurrent cSCC, which recently completed patient enrollment, under which the Banner MD Anderson team has also treated multiple patients. Immunocompromised patients face dramatically higher rates of cSCC, the second most common type of skin cancer in the U.S., than the general population - as much as 65- to 100-fold among organ transplant recipients specifically. For many patients in this population, the general treatment options for recurrent cSCC can actually cause real harm: checkpoint inhibitor immunotherapy, the standard option for the general population, carries a documented risk of triggering rejection of a transplanted organ. Alpha Tau Medical Ltd. announced the successful treatment of the first patient in the ADMIRE (Alpha DaRT Management for Immunocompromised patients with REcurrent cSCC) study - a clinical trial evaluating intratumoral Alpha DaRT for immunocompromised patients with recurrent cutaneous squamous cell carcinoma (cSCC). The procedure was performed at Banner MD Anderson Cancer Center in Gilbert, Arizona. Immunosuppression is one of the strongest known risk factors for cSCC, whether it results from organ transplantation, hematologic malignancies such as chronic lymphocytic leukemia (CLL), or long-term treatment for autoimmune disease. An estimated 17 million U.S. adults are living with immunosuppression. These immunosuppressed patients face a much higher chance of developing cSCC; organ transplant recipients, for example, face a 65- to 100-fold higher incidence than the general population. Standard local treatments for these patients become progressively harder to repeat: surgical excision carries cumulative morbidity, and repeated procedures bring a growing degree of surgical fatigue and diminishing healthy tissue to work with, while radiation therapy is constrained by cumulative dose limits that frequently preclude re-treating the same field. This underscores the need for a localized treatment for this population that can be delivered in a single procedure and be repeated at the same site if the disease returns. For transplant recipients, physicians must often reduce immunosuppressive therapy once cancer is diagnosed, which raises the risk of organ rejection, and checkpoint inhibitor immunotherapy, a standard option for recurrent or advanced cSCC in the general population, is therefore typically avoided in these patients. Patients with CLL and other hematologic malignancies, and those on chronic immunosuppressive therapy for autoimmune disease, face a related but distinct problem: cSCC clinical trials have historically excluded immunocompromised patients as a category, regardless of the specific cause, leaving many without access to newer treatment options at all. The ADMIRE study was designed specifically to evaluate whether Alpha DaRT, delivered locally and directly into the tumor, can offer a meaningful alternative across this historically excluded and particularly vulnerable population. ADMIRE (Protocol CTP-SCC-04) is a prospective, multicenter, open-label, single-arm clinical study evaluating intratumoral Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma in immunocompromised patients. The study was initially announced in September 2024 as an investigator-initiated trial and is now conducted as a company-sponsored study. The study is designed to enroll up to 28 patients at up to 8 sites across the United States. Eligible patients must have histologically confirmed, recurrent cSCC with a single lesion up to 7 cm, and must be immunocompromised due to any primary or secondary immunodeficiency, including solid organ transplantation, hematologic malignancy, or chronic immunosuppressive therapy for autoimmune disease; diabetes alone does not qualify. The primary endpoint is objective response rate (ORR) based on best overall response per RECIST v1.1; secondary endpoints include progression-free survival, overall survival, and local control, each assessed over twelve months. Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
