AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.
- First complete responder survives two years cancer-free
- Second complete responder reaches one-year survival
- 14% overall complete response rate in 14 patients
- Manufacturing transfer to Australia underway
- Pre-IND meeting with US FDA planned for H2 2026
Rare Two-Year Cancer-Free Survival in Advanced Mesothelioma
AdAlta Limited’s (ASX:1AD) lead CAR-T cell therapy EW-001 has reached a milestone few treatments for advanced mesothelioma can claim: the first patient to achieve complete tumour clearance remains free of cancer recurrence two years after a single dose. A second patient who also achieved complete response has now passed the one-year survival mark, highlighting the therapy’s potential for durable disease control in a cancer type where such outcomes are exceptionally rare.
Mesothelioma, a rapidly fatal cancer linked to asbestos exposure, typically offers poor prognosis once first-line chemotherapy or immunotherapy fails. Complete tumour clearance; where no detectable cancer remains; is almost unheard of in advanced cases. Published studies usually report complete response rates near zero, making EW-001’s 14% complete response rate across all 14 evaluable patients, and 20% among those receiving higher doses, a striking result.
Clinical Evidence Strengthens EW-001’s Promise
These durable responses suggest EW-001 could shift expectations for second-line mesothelioma treatment. The first patient’s CT scans showed two large tumours shrinking to undetectable levels within three months, with no recurrence detected two years on. While the second patient’s tumour status at one year remains unconfirmed by imaging, survival beyond 12 months itself is notable in this context.
AdAlta CEO Dr Tim Oldham emphasised the significance: “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.”
Manufacturing and Regulatory Milestones in Sight
Beyond clinical data, AdAlta is advancing two strategic steps to support EW-001’s development. The company is transferring manufacturing to Cell Therapies Pty Ltd in Australia, with the first local production runs expected in the second half of 2026. Concurrently, AdAlta is preparing for a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration, also anticipated in H2 2026. These moves aim to establish a robust Australian manufacturing platform and secure regulatory guidance for upcoming clinical trials.
This approach aligns with AdAlta’s “East to West” strategy, integrating Asian innovation in cellular immunotherapies with Australian clinical and manufacturing expertise. The company’s focus on solid tumours, which represent 90% of cancers yet remain underserved by current CAR-T therapies, positions EW-001 as a potential breakthrough in a high-growth market projected to reach US$20.3 billion by 2028.
Clinical Trial Context and Limitations
It is important to note the data comes from an investigator-initiated trial involving a small patient cohort. While the complete response rate and durability are promising, larger controlled studies will be necessary to confirm efficacy and safety. Additionally, the absence of imaging at the one-year mark for the second responder introduces some uncertainty about the ongoing tumour status.
Nonetheless, the ongoing follow-up of all patients and periodic reporting of survival and response data will be critical to building the clinical evidence package for EW-001. These data will also inform regulatory discussions and potential partnerships for further development and commercialisation.
Bottom Line?
EW-001’s rare durable responses in advanced mesothelioma patients spotlight a potential new treatment frontier, but upcoming regulatory and manufacturing milestones will be key to translating promise into broader clinical impact.
Questions in the middle?
- Will longer-term data confirm EW-001’s durability beyond two years?
- How will regulatory feedback from the US FDA shape future trial design?
- Can Australian manufacturing scale efficiently to support wider clinical use?