Alpha Tau Initiates First U.S. Patient Treatment in Pancreatic Cancer Trial Combining Alpha DaRT with Chemotherapy
Key Insights
Alpha Tau Medical has successfully treated the first patient in its U.S. multi-center IMPACT trial, evaluating Alpha DaRT (search) radiation therapy combined with chemotherapy for unresectable pancreatic adenocarcinoma (search).
The study targets a critical unmet need, as up to 87% of newly diagnosed pancreatic cancer (search) patients are considered inoperable at diagnosis and face limited treatment options.
Alpha DaRT (search) delivers localized alpha radiation through intratumoral implantation, designed to achieve tumor control in a single session while potentially sparing surrounding healthy tissue.
Alpha Tau Medical Ltd. has achieved a significant milestone in its pancreatic cancer (search) program with the successful treatment of the first patient in its U.S. multi-center pilot study. The IMPACT (Intratumoral Pancreatic Alpha Combination Trial) represents a novel approach to treating one of the most challenging cancers, combining the company's Alpha DaRT (search) radiation therapy with standard chemotherapy for patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma (search).
Addressing Critical Unmet Medical Need
Pancreatic cancer (search) represents the third leading cause of cancer-related death in the United States, with approximately 66,000 new cases diagnosed annually. The disease presents a particularly dire clinical challenge, as up to 87% of newly diagnosed patients are considered inoperable at diagnosis due to either locally advanced disease or distant metastases. These patients face a dismal prognosis with limited benefit from existing systemic therapies.
"With the vast majority of pancreatic cancer (search) patients deemed inoperable at diagnosis, the need for innovation is urgent," stated Uzi Sofer, CEO of Alpha Tau. "The initiation of the IMPACT trial in the U.S. marks an important step by exploring how Alpha DaRT (search), with its ultra-high dose and localized alpha radiation, might complement chemotherapy in treating this terrible disease."
Novel Alpha Radiation Technology
The first patient was treated at the University Cancer Centers (search) in Houston by a multidisciplinary team led by Principal Investigator Dr. Mark D'Andrea, a radiation oncologist, and gastroenterologist Dr. Isaac Raijman. The treatment utilized Alpha DaRT (search)'s unique approach to delivering targeted radiation therapy directly into tumor tissue.
"The Alpha DaRT (search) sources are designed to emit powerful alpha particles that travel only a short range in tissue. This is ideal for pancreatic tumors, which are surrounded by critical structures," explained Dr. D'Andrea. "Its biological effectiveness may offer a new way to achieve local control in a conformal manner in one session, instead of a more lengthy treatment seen with conventional radiation therapy."
The technology employs radium-224 (search) impregnated sources that are implanted directly into tumors. When radium decays, its short-lived daughters are released and disperse while emitting high-energy alpha particles designed to destroy tumor tissue while sparing surrounding healthy structures.
Precision Delivery Method
Dr. Raijman highlighted the technical advantages of the delivery approach, noting that "Alpha DaRT (search) sources were delivered into the pancreatic tumor under real-time endoscopic ultrasound guidance, enabling a seamless and accurate delivery through a minimally invasive approach. This non-surgical technique makes it possible to reach deeply located tumors with precision, and with potentially less side effects."
Comprehensive Study Design
The IMPACT study aims to enroll up to 30 patients, comprising 15 patients with inoperable locally advanced disease and 15 patients with metastatic disease, across multiple centers in the U.S., Canada, and Israel. Eligible patients must have newly diagnosed, histologically confirmed pancreatic adenocarcinoma (search) and must be inoperable, non-irradiated, and either chemotherapy-naïve or within the first four cycles of their initial chemotherapy regimen.
Patients will continue receiving standard-of-care chemotherapy (mFOLFIRINOX (search)) throughout the study, with Alpha DaRT (search) sources implanted into the primary tumor using ultrasound-guided endoscopy. Follow-up will continue for up to six months after enrollment.
Primary and Secondary Endpoints
The study's primary objectives focus on assessing the feasibility of Alpha DaRT (search) source implantation and evaluating safety and tolerability, specifically monitoring for Grade 3 or higher adverse events related to the device. Secondary objectives include evaluating local tumor response using RECIST criteria and volumetric imaging, measuring time to local progression, monitoring progression-free survival and overall survival, and collecting patient-reported outcomes related to pain control.
For patients with inoperable locally advanced disease, the study will evaluate the percentage who become surgically resectable after treatment with Alpha DaRT (search), representing a potentially significant clinical outcome.
Strategic Development Path
Dr. Robert Den, Chief Medical Officer of Alpha Tau, emphasized the study's role in the company's broader development strategy: "This study incorporates a thoughtful design based on our pre-clinical work to explore the integration of Alpha DaRT (search) with chemotherapy in both locally advanced and metastatic pancreatic cancer (search). We are focused on generating high-quality clinical data on safety and early efficacy to inform our future development path."
The trial builds on Alpha Tau's expanding clinical program aimed at solid tumors with limited local treatment options and aligns with the company's mission to develop technologies that deliver alpha radiation precisely to tumor sites. This pilot study represents a key component of Alpha Tau's broader strategy to bring Alpha DaRT (search) to cancer patients with some of the highest unmet medical needs.