On July 15, 2026 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported 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, by Michael Samuels, MD, Chief of Multidisciplinary Programs at Banner MD Anderson Cancer Center and Principal Investigator of the ADMIRE study at this site, along with Thomas Shellenberger, MD, Head and Neck Cancer Surgical Oncologist.
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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. Further, 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.
Beyond the physical toll of repeated procedures, these patients face a second barrier: 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.
Uzi Sofer, CEO of Alpha Tau, stated: "This milestone matters to us for a reason that goes beyond any one patient. There are many different reasons someone can become immunocompromised, but across nearly all of them, the same pattern holds: their cSCC comes back more often, and leaves them with far fewer treatment options than for others. This trial actually started with our physicians. Since we began enrolling ReSTART, our pivotal trial for recurrent cSCC, investigators at site after site have asked the same question on their own, right up to recently: could Alpha DaRT help their immunocompromised patients too, the ones ReSTART couldn’t enroll? That’s exactly the kind of trial our strategy is built around: treating patients whose tumors recur after surgery or radiation therapy, who are left with limited treatment options, and who need new solutions the most."
Dr. Michael Samuels, Chief of Multidisciplinary Programs at Banner MD Anderson Cancer Center, commented: "Our team has treated multiple patients under Alpha Tau’s ReSTART trial for recurrent cSCC, and that experience is exactly what gave us the confidence to bring Alpha DaRT to our immunocompromised patients through ADMIRE. Banner sees a significant number of transplant patients and patients with other causes of immunosuppression across across our network, many of whom go on to develop skin cancers that recur despite prior surgery or radiation, and who have very few good options left. Today’s patient came to us in exactly that situation, and I’m glad to say the treatment went smoothly, with the kind of single-session, localized procedure our patients need. I’m looking forward to seeing how this patient, and the others who will follow, respond over the coming months."
Dr. Robert Den, Chief Medical Officer of Alpha Tau, added: "ADMIRE is a natural extension of everything we’ve learned through ReSTART and, before that, through our original skin cancer feasibility study, which showed strong local tumor control in a population where nearly two-thirds already had recurrent disease. Bringing this treatment to a system like Banner, which already has both the transplant and oncology expertise this population requires, is exactly how we intend to build out this program. We’re grateful to Dr. Samuels and his team, and we look forward to following this patient’s progress."
About the ADMIRE Study
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. Additional information about the study is available at View Source
(Press release, Alpha Tau Medical, JUL 15, 2026, View Source [SID1234669226])