Alpha Tau Medical Ltd. is widening its U.S. clinical trial for a novel alpha-radiation cancer therapy, adding a second standard chemotherapy to the study and increasing patient enrollment by 33 percent in a push to find new solutions for one of the deadliest cancers. The expansion of the IMPACT trial, approved by the U.S. Food and Drug Administration, adds another arm to the company's growing global clinical program for pancreatic cancer.
"Expanding our trial to include patients receiving either of the leading standard-of-care first-line chemotherapies offers us a broader potential development path to use Alpha DaRT in treating this terrible disease,” said Robert Den, MD, Chief Medical Officer of Alpha Tau. The company's stock (Nasdaq: DRTS) has been closely watched by investors as it advances its unique cancer therapy.
The FDA’s approval of an Investigational Device Exemption (IDE) supplement allows the IMPACT trial to enroll an additional 10 patients with unresectable locally advanced or metastatic pancreatic cancer. These patients will be treated with Alpha Tau's Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) in combination with the chemotherapy regimen of gemcitabine and nab-paclitaxel. This is in addition to the 30 patients already approved to be treated with Alpha DaRT alongside the mFOLFIRINOX chemotherapy regimen, bringing the total trial size to 40 patients.
This dual-chemotherapy approach is significant because it covers the two primary first-line treatments for advanced pancreatic cancer. The expansion, however, will push the timeline for completing patient recruitment from the second quarter to the third quarter of 2026. The primary goals of the study are to assess the safety and feasibility of the Alpha DaRT implantation, with secondary goals including tumor response and overall survival. A key metric for patients with inoperable locally advanced disease will be the rate at which they may become eligible for surgery after treatment.
A Two-Front Strategy
Alpha Tau's efforts in pancreatic cancer are not limited to the U.S. The company is also conducting the ACAPELLA trial in Europe, which recently treated its first patient. This trial evaluates Alpha DaRT in combination with a different chemotherapy, capecitabine, for patients who have already completed a course of mFOLFIRINOX. Together, the IMPACT and ACAPELLA trials represent a comprehensive strategy to gather data on Alpha DaRT's efficacy in different patient populations and in combination with various standard treatments.
The Alpha DaRT technology itself is a novel approach to radiation therapy. It involves implanting radium-224-impregnated sources directly into a tumor. As the radium decays, it releases alpha-emitting atoms that diffuse a short distance, delivering a potent and localized dose of radiation intended to destroy the tumor while sparing surrounding healthy tissue. This approach is particularly promising for difficult-to-treat tumors like those in the pancreas.
The broader landscape for pancreatic cancer treatment is also seeing new developments. Researchers are making progress with KRAS-blocking drugs, which target a genetic mutation present in nearly 90 percent of pancreatic tumors. One such drug, daraxonrasib, showed in a phase 3 trial that it could nearly double survival when combined with chemotherapy. While these targeted therapies are promising, Alpha Tau's radiation-based approach offers a different and potentially complementary strategy, reflecting a multi-pronged attack on this challenging disease.
This article is for informational purposes only and does not constitute investment advice.
