Galvanize Therapeutics has announced the positive six-month results from its Affinity clinical trial which demonstrated the Aliya pulsed electric field (PEF) ablation system is safe and provides high local control when used to treat lung tumours.
Published in the journal Cancers, the Affinity trial is a prospective, non-randomised, open-label, single-arm study evaluating the safety and feasibility of Aliya PEF ablation. The publication describes six-month results for 28 evaluable patients who received lung tumour ablation, followed by additional standard-of-care treatment when deemed appropriate by the treating physician and multidisciplinary team members.
Affinity demonstrated that Aliya PEF ablation at the time of diagnostic biopsy is safe and does not preclude administration of subsequent therapies. High local control rates of ablated tumours were achieved both in patients on concurrent therapy (94% in 16 patients) and those with no additional therapy (100% in 12 patients). The data also suggests that Aliya PEF may induce systemic immune activation in patients with stage IV non-small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates.
“These data provide encouraging evidence that Aliya PEF ablation can achieve meaningful local control even in patients with advanced, metastatic disease,” Michael A Pritchett (Firsthealth of the Carolinas, Pinehurst, USA), investigator in the study. “Equally important, we’re seeing evidence that Aliya PEF may also trigger systemic immune activation. These findings suggest a promising opportunity to provide focal ablation adjunctive with immunotherapy to potentially enhance outcomes.”
Six-month Affinity study results showed a favourable safety profile. The Aliya PEF ablation procedure was successfully delivered in 100% of patients. Procedures were well-tolerated, including bilateral ablations, with no delays to standard-of-care therapy and only one percutaneous procedure-related serious adverse event (pneumothorax) that resolved without sequelae.
The investigators also demonstrated high local tumour control. The research team’s findings show that 96% of patients achieved local tumour control, defined as local stable disease, local partial response, or local complete response of ablated lesions in the lungs. All patients who received ablation-alone (n=12) achieved local control of treated lesions without subsequent systemic therapy.
Furthermore, the research team highlighted systemic immune activation following treatment. Patients who only received Aliya PEF ablation without subsequent therapy (n=12) experienced a robust activation of both adaptive and innate immunity. This is consistent with immunogenic therapies like cancer immunotherapy or vaccination.
“The Affinity results further heighten our confidence in the Aliya PEF ablation technology,” said Doug Godshall, chief executive officer of Galvanize Therapeutics. “We are compelled to find ways to improve the lives of the patients our clinical partners treat and we continue to invest in research to demonstrate Aliya PEF’s ability to effectively ablate tumours locally while also stimulating the body’s immune system.”
Unlike traditional thermal ablation techniques, Aliya PEF uses short-duration, high-voltage electrical pulses to induce cell death without damaging the surrounding sensitive structures. The innovative Aliya PEF approach can be delivered percutaneously or endoscopically with the INUMI Flex needle. To date, more than 2,000 patients have received Aliya ablation commercially and in clinical trials in the USA.
The Aliya PEF System and the INUMI Flex needle are 510(k) cleared in the USA for the surgical ablation of soft tissue. They are not currently commercially available in any other geography.
