Two-year cancer-free survival milestone headlines AdAlta’s EW-001 mesothelioma results
AdAlta Limited (ASX:1AD) has reported that the first patient to achieve a Complete Response to its lead CAR-T cell therapy, EW-001, has now passed two years of survival without cancer recurrence following a single dose, a durability milestone rarely seen in advanced mesothelioma.
A second Complete Responder has reached 12 months of survival following treatment. No imaging assessment was performed at the one-year milestone, so this patient’s current tumour status is not available.
Durable responses measured in years are almost never seen in patients with advanced mesothelioma, where second-line Complete Response rates are typically 0%. EW-001 (formerly BZDS1901) is AdAlta’s lead CAR-T cell therapy, tested in an ongoing Investigator Initiated Trial (IIT) in China.
When big ASX news breaks, our subscribers know first
Complete Response rates that stand apart in advanced mesothelioma
Complete tumour clearance is almost never achieved in advanced mesothelioma once the disease has returned or progressed following initial therapy. The results reported from the ongoing IIT in China stand out against published benchmarks, where the major studies report second-line Complete Response rates of 0%.
Across the current generation of EW-001, the therapy has delivered Complete Responses in 2 of 10 patients treated at higher doses (20%), and 14% of the 14 evaluable patients overall. The table below contextualises these figures against typical second-line mesothelioma outcomes.
The 50% Overall Response Rate recorded at higher doses in the earlier March 2026 data readout established the foundation for these durability figures, with the two Complete Responders now tracked well beyond the timeframes initially reported.
| Metric | EW-001 (higher doses) | EW-001 (all evaluable) | Typical second-line mesothelioma |
|---|---|---|---|
| Complete Response rate | 20% (2 of 10) | 14% (2 of 14) | ~0% |
| Overall Response rate | — | Up to 50% | 11–29% |
| Durability | Patient #1: 2 years cancer-free | — | Median survival 8–10 months |
The two survival milestones reported are:
-
First Complete Responder: two years post single dose, with no cancer recurrence.
-
Second Complete Responder: 12 months survival (imaging was not performed at the one-year milestone).
Figure 1 in the announcement shows CT scans from patient #03, in which two large 5cm tumours shrank consistently after treatment to become undetectable three months later. This patient has now passed two years since treatment without signs of cancer recurrence.
What CAR-T therapy is and why durability matters
CAR-T (chimeric antigen receptor-T cell) therapy is a “living drug” manufactured from a patient’s own immune cells. Those cells are engineered in a laboratory to carry a receptor that binds to a molecule on the surface of a cancer, enabling the immune cells to find and kill it. The therapy carries the potential for a single dose to have durable effects and to be potentially curative.
Mesothelioma is a rare but rapidly fatal cancer of the membranes surrounding the lungs, heart and gastrointestinal organs, usually linked to asbestos exposure. Patients are typically treated first with chemotherapy or immunotherapy. Once the disease returns or progresses, therapeutic options are limited and outcomes are generally poor.
A Complete Response means no tumour can be detected after treatment. Achieving and maintaining that response is associated with the potential for durable disease control, making it an important outcome for patients, regulators and prospective commercialisation partners. For investors, durability is what can turn an early clinical signal into a commercially valuable, partnerable asset.
CEO Commentary
“Complete tumour clearance is almost never seen in patients with advanced mesothelioma. To have achieved it in two (20%) of the ten patients treated at the higher EW-001 doses is highly encouraging – and to see the first of those patients still free of cancer recurrence two years after a single infusion is the kind of result that changes the conversation with patients, regulators and partners,” said Dr Tim Oldham, CEO and Managing Director.
Next steps: Australian manufacturing and US FDA engagement
AdAlta is progressing two development milestones for EW-001, both anticipated in H2 CY2026:
-
Australian manufacturing transfer to Cell Therapies Pty Ltd, with the first Australian manufacturing runs expected during H2 CY2026.
-
A pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA), anticipated in H2 CY2026.
The pre-IND meeting with the US FDA anticipated in H2 2026 is backed by a regulatory data package strengthened in June, when AdAlta completed its final milestone payment to SHcell and secured FDA-submission-ready safety data and CAR-T cell persistence records from five additional patients treated in China.
Together these steps are intended to establish an Australian manufacturing platform, obtain regulatory guidance and support the planned Australian Phase 1 clinical study of EW-001. AdAlta has stated it will continue to follow all patients remaining on study and anticipates reporting additional survival and durability data periodically as it becomes available.
Why this matters for shareholders
For shareholders, the value of this update rests on two elements identified by the Company.
Durability is the first. A single dose of EW-001 has now kept one patient free of an aggressive cancer for two years. Responses measured in years rather than weeks or months are particularly meaningful in advanced cancer and provide evidence of the therapy’s potential durability.
Evidence development is the second. Every additional month of patient survival and follow-up strengthens the clinical evidence supporting EW-001 and the information package AdAlta can present to regulators and prospective development or commercialisation partners.
These milestones sit within AdAlta’s “East to West” strategy, which integrates Asian innovation in cellular immunotherapy with Australia’s clinical and manufacturing ecosystem. The Company in-licenses products from Asian originators and invests to establish US FDA regulated manufacturing and conduct Phase I clinical studies, positioning each asset for potential on-licensing to larger biopharmaceutical companies.
The broader market context remains significant. Solid tumours account for 90% of cancers yet remain underserved by current cellular immunotherapies. The cellular immunotherapy market is projected to grow at a compound annual growth rate of 34% to reach US$20.3 billion by 2028.
AdAlta has cautioned that Investigator Initiated Trials involve small numbers of patients and are not a substitute for controlled clinical studies. The results reported to date represent early clinical signals rather than confirmed or guaranteed outcomes. Even so, the Company states that a signal of this kind in a disease with so few options continues to underpin its confidence in EW-001 and in its “East to West” strategy.
Don’t Miss the Next Healthcare Breakthrough
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis. Join 20,000+ subscribers already getting the full picture the moment market-moving announcements drop. Click the “Free Alerts” button at StockWire X to stay ahead of the market.