AdAlta’s CAR-T Therapy Delivers Rare Tumour Disappearances in Mesothelioma Trial
AdAlta’s BZDS1901 CAR-T therapy shows remarkable tumour shrinkage and complete responses in advanced mesothelioma patients, doubling expected outcomes and paving the way for higher dosing and expanded trials.
- 50% overall response rate at higher BZDS1901 doses
- 20% of patients achieved complete tumour disappearance
- 14 advanced mesothelioma patients treated after failing prior therapies
- Improved safety profile enables exploration of increased dosing
- Plans underway for additional patient cohorts and Western clinical development
Breakthrough in Tough-to-Treat Mesothelioma
AdAlta Limited (ASX:1AD) has reported compelling new clinical data from its ongoing trials of BZDS1901, a first-in-class CAR-T cell therapy targeting advanced mesothelioma. The therapy, developed through its subsidiary AdCella Pty Ltd, has demonstrated tumour shrinkage in half of the patients receiving the highest doses, with an unprecedented 20% achieving complete tumour disappearance, a rarity in this notoriously difficult cancer.
Mesothelioma, often linked to asbestos exposure, is aggressive and resistant to conventional treatments. Patients who relapse after chemotherapy or immunotherapy typically face poor prognoses, with median survival under nine months and low response rates. Against this backdrop, BZDS1901’s results stand out for their potential to shift the treatment paradigm.
Clinical Results and Safety Advances
In the investigator-initiated trials conducted by Shanghai Cell Therapy Group in China, 14 patients with advanced mesothelioma were treated with the Generation 2 version of BZDS1901. Among the ten patients receiving the highest doses, five showed tumour shrinkage exceeding 30%, and two experienced complete responses where tumours became undetectable on CT scans. One patient’s tumours, initially 5cm in size, vanished within three months and remained undetectable 18 months later.
These outcomes are nearly double the overall response rates seen with current second-line therapies. Moreover, the updated safety protocols have allowed administration of higher doses with manageable toxicities, including no severe cytokine release syndrome and only one transient neurological event. This improved safety profile supports the potential for further dose escalation in future studies.
Strategic Implications and Next Steps
AdAlta’s CEO Tim Oldham emphasised the significance of these findings, highlighting the therapy’s promise to offer new hope for patients with limited options. The company is actively planning an extension cohort to treat additional patients and is focused on advancing BZDS1901 into Western clinical development, aiming to bring this innovation to markets beyond China.
AdAlta’s approach leverages Asia’s expertise in T cell therapies combined with Australia’s clinical and manufacturing capabilities. The company’s broader pipeline also includes novel treatments for fibrotic diseases and malaria, positioning it as a versatile player in biotechnology innovation.
While the sample size remains modest and longer-term survival data is still maturing, the clinical progress of BZDS1901 marks a notable step forward in the quest for effective cellular immunotherapies against solid tumours, a sector poised for significant growth.
Bottom Line?
AdAlta’s promising mesothelioma results set the stage for expanded trials and potential Western market entry, but long-term outcomes remain to be seen.
Questions in the middle?
- Will higher doses of BZDS1901 maintain safety while improving efficacy?
- How will regulatory pathways in Western countries shape BZDS1901’s development timeline?
- Can BZDS1901’s success in mesothelioma translate to other solid tumours?
