Alpha DaRT treatment works for first 3 glioblastoma patients in early trial
No detectable cancer seen for 2 on brain imaging scans after radiation therapy
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In an early clinical trial testing the novel therapy Alpha DaRT for recurrent glioblastoma, the first three patients given the radiation treatment all showed a positive response, according to an interim update from developer Alpha Tau.
New data shared by the company show two patients achieved a complete response, meaning they no longer have detectable cancer on imaging scans. In the third patient, the tumor didn’t completely resolve, but it decreased in size by about 30%, the data showed.
Further, none of the patients has had any recurrence of the aggressive brain cancer as of the latest follow-up, according to a company press release, which noted the “100% local disease control” seen with Alpha DaRT’s use.
“Today is a very important day for Alpha Tau,” said Uzi Sofer, the company’s CEO. “These results confirm that we are on target with pursuing our core strategy of offering new treatment possibilities to those who need it most.”
Alpha Tau reports that the treatment has been well-tolerated overall so far. One of the patients experienced a serious side effect — a seizure that resulted in temporary paralysis — but this was resolved with steroid medications. As of the latest follow-up, none of the patients have any lingering safety issues from the treatment procedure, the company said.
The interim results were compiled to comply with a U.S. Food and Drug Administration (FDA) request for early safety data, according to Alpha Tau. The company said it plans to share these findings with the FDA and, pending regulatory approval, will continue enrolling patients in the ongoing Phase 1 trial (NCT06910306).
The study aims to involve a total of 10 people with glioblastoma that is recurrent, meaning the cancer has come back following prior treatments. Recruitment is ongoing at The Ohio State University Medical Center in Columbus.
“These results are extremely exciting and we look forward to continuing to treat patients in our recurrent glioblastoma trial, pending FDA confirmation following review of our safety report, and to expanding this work into further indications in brain cancer and other high-mortality settings where patients urgently need new approaches,” Sofer said.
Alpha DaRT offers a new type of radiation therapy
Glioblastoma is an especially aggressive form of glioma, a type of brain cancer caused by the uncontrolled growth of nervous system cells called glia.
“Glioblastoma is one of the most devastating diagnoses in oncology. Approximately 14,000 Americans are newly diagnosed each year, recurrence is virtually inevitable, and the five-year survival rate remains below 10%,” Sofer said. “Once the disease returns, median survival is typically measured in only a handful of months.”
Radiation has been a staple of cancer treatment for decades: High-energy radiation can damage DNA in rapidly dividing cancer cells, thus killing them. Traditional cancer radiation treatment uses machines that direct beams of radiation toward a tumor inside a patient’s body.
Alpha DaRT, short for Diffusing Alpha-emitters Radiation Therapy, offers a “groundbreaking” twist on this treatment, according to its developer. Instead of directing beams toward the cancer, the therapy aims to implant a radioactive source directly into a tumor, emitting short-range radiation to kill the cancer cells with minimal damage to healthy tissue.
Watching these first several patients journey through therapy, and seeing their excellent responses and ability to get back to their lives so quickly, marks a critical moment in [brain] oncology, in that we may have helped unlock a novel treatment for highly resistant brain tumors.
According to Joshua D. Palmer, MD, the trial’s principal investigator, “the physics of alpha emitters address a long-standing problem in [brain] radiation oncology: escalating intratumoral dose without injuring sensitive and critical brain tissue.”
“Hopefully seeing that translate into durable responses in our first patients is an important early signal,” said Palmer, a radiation oncologist at Ohio State’s cancer center.
Palmer noted that a 2023 analysis of glioblastoma treatments showed response rates of less than 5% to slightly more than 25% — “nothing approaching the responses we’ve seen so far to Alpha DaRT.”
“Watching these first several patients journey through therapy, and seeing their excellent responses and ability to get back to their lives so quickly, marks a critical moment in [brain] oncology, in that we may have helped unlock a novel treatment for highly resistant brain tumors,” Palmer said.
