The Australian biotechnology firm AdAlta reported that a patient with advanced mesothelioma has achieved complete response and remained free of cancer recurrence for over two years after a single dose of its experimental CAR T-cell therapy EW-001 as part of a study in China.
In addition, another patient has survived more than 12 months with complete response after receiving the experimental treatment, representing a response rate of 20% among the 10 patients treated at higher doses.
These results were announced last week as part of a July clinical update on the study, which revealed that all five patients remaining in the study as of their previous update in March were still alive and in follow-up. AdAlta has hailed these results, which could indicate serious advancements in response rate and survival time for advanced mesothelioma, as groundbreaking.
“Every one of the five patients still on study in March remains alive, and the higher the EW-001 dose, the better patients have done,” said AdAlta CEO and Managing Director Dr. Tim Oldham in a release. “Combined with two patients achieving complete tumor clearance also at these higher doses, something almost never seen in advanced mesothelioma, this supports our plan to evaluate even higher doses in our Australian Phase 1 study. For patients with advanced mesothelioma, who today have very few options, EW-001 offers real new hope – and for our shareholders it strengthens the value we are building in this program.”
What is CAR T-cell therapy?
Chimeric antigen receptor (CAR) T-cell therapy is a type of immunotherapy that focuses on genetically changing cells within the body’s immune system to help them fight cancer. In CAR T-cell therapy, scientists genetically engineer the T-cells in the patient’s body to target cancer cells carrying specific proteins.
Providers collect T-cells from the patient’s bloodstream, genetically modify and multiply them in a laboratory to target the patient’s cancer, and then re-infuse them into the patient. Once returned to the bloodstream, they set out on their mission to attack cancer cells.
CAR T-cell therapy has been shown to be highly effective against a number of blood cancers, including leukemia and lymphoma, and a number of studies have shown promise in their use against solid tumor cancers such as mesothelioma.
CAR T-cell therapy is still in the clinical trial testing phase for mesothelioma, with CAR T-cells being engineered to target the protein mesothelin, found on the surface of mesothelioma cells. AdAlta has been testing its CAR T-cell therapy at doses considered “modest by CAR-T standards,” but said that it has found that patients receiving higher doses have responded better to treatment with well-managed adverse effects.
What Could These Results Mean for Mesothelioma Treatment?
AdAlta’s results are particularly head-turning because complete response – meaning all detectable signs of cancer in the body have disappeared after treatment – is extremely rare in advanced mesothelioma. Most major published studies looking at advanced mesothelioma patients have reported complete response rates of 0%.
Although still in a small sample of patients as part of an ongoing trial, AdAlta reported that EW-001, aside from its much higher complete response rate, also showed an overall response rate that compares favorably with first-line therapies, and is much higher than other second-line therapies.
If these results are sustained, they could prove to be a major affirmation of CAR T-cell therapy’s potential use in mesothelioma treatment. AdAlta said that as it continues to collect follow-up data from patients remaining in the study, it is transferring its manufacturing process to its home country of Australia and aims to start its first Australian manufacturing runs in last months of 2026.
In addition, the company is preparing for a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration some time in the second half of 2026, before embarking on a Phase 1 clinical study of EW-001.
Sources & Author
- EW-001 IIT study overall survival update. Listcorp. Retrieved from: https://www.listcorp.com/asx/1ad/adalta-limited/news/ew-001-iit-study-overall-survival-update-3387319.html. Accessed on 08/11/2026.
