PEF Ablation Yields Local Control, May Elicit Immune Response in Solid Tumors

Aliya pulsed electric field (PEF) ablation may promote local tumor control and modulate systemic immune function without impact on subsequent standard-of-care therapy in patients with metastatic solid tumors, according to 6-month results from the interventional AFFINITY trial (NCT05890872) published in Cancers.¹

During the trial, 2 cohorts of patients emerged: cohort 1, which included patients treated with ablation alone (n = 12), and cohort 2, which enrolled patients receiving additional systemic and/or focal therapies (n = 16). The distribution of patients who had solitary, oligofocal, and multifocal cases was similar between the groups (P <.99). The investigators noted that the study was not designed to randomize patients into these groups, but that the distinct cohorts emerged during data analysis.

Six months after ablation, 33% (n = 4/12) of patients who did not receive additional therapy achieved local partial responses (PR), and 67% (n = 8/12) achieved local stable disease (SD). In the additional therapy cohort, 6% (n = 1/16) of patients achieved local complete responses (CRs), 50% (n = 8/16) achieved local PRs, and 38% (n = 6/16) achieved local SD. One patient had local disease progression and died due to respiratory failure about 7.3 months after ablation.

Of the 13 patients in the cohort analyzed by flow cytometry, all achieved local control by 6 months; 5 achieved local PRs and 8 achieved local SD. Analysis found that natural killer (NK)-cells increased during the middle phase and activated CD4+ CD28+ T-cells were significantly elevated at all time points; Activated Memory B-cells were significantly increased in the early and middle phases, and plasmablasts were increased across all 3 time points. Decreases were identified in Regulatory T-cells in the late phase, naïve CD8+ T-cells during the middle and late phases, naïve B-cells in the middle phase, and Central Memory CD4+ T-cells at the middle and late phases. Twenty additional immunocyte populations among the 29 analyzed did not show significant changes compared with baseline.

In the 12 patients who did not receive additional therapy, 9 had matched serum and biopsy samples to assess biopsy-specific IgG, and 11 had baseline and follow-up serum available for assessing changes in tumor-associated antigen (TAA)-specific IgG. Of the 9 patients assessable for biopsy-specific IgG, 33% had a rise of 20% or more in their biopsy-specific IgG1 and 1 or more post-treatment time points. No patients exhibited statistically significant modulation of IgG levels at the chronic time point, but 1 with a late time point rise had no chronic time point sample available for analysis. Magnitude of response varied from a 41% to 96% increase over baseline; a single patient had a 19% decrease in biopsy-specific IgG at the late time point. Regarding statistically significant TAA-specific IgG level changes, reduced MAGE-A3–, WT1–, and NY-ESO-1–specific IgG was observed in 7, 5, and 5 patients, respectively.

In a press release on the findings, Michael A. Pritchett, DO, MPH, director of the Chest Center of the Carolinas and interventional pulmonologist at First Health of the Carolinas and investigator in the study, stated, “These data provide encouraging evidence that Aliya PEF ablation can achieve meaningful local control even in patients with advanced, metastatic disease. 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.”²

A total of 31 patients were enrolled in the trial, though 28 patients were included in the analysis. Eligible patients had a diagnostic lung biopsy for suspected malignancy, were not surgical candidates for curative-intent, had not previously received treatment for their targeted tumors, and were indicated for first-line therapy for their targeted tumor.

The median age at consent was 66 years (range, 28-85), 50% of patients were female, and 71.4% of patients had an ECOG performance status of 0. Included malignancy groups were colorectal (17.9%), neuroendocrine (10.7%), non–small cell lung cancer (14.3%), other (32.1%), renal (17.9%), and sarcoma (7.1%).

Patients received ablation either bronchoscopically or percutaneously, with follow-up occurring on days 3, 10, and 30, as well as months 3, 6, 9, and 12. Adjuvant systemic therapy and/or focal therapy were administered at the discretion of the treating physician.

Previously, data on the study’s safety end points were reported, and demonstrated an acceptable safety profile.³ The ablation procedure was well-tolerated, including in patients with bilateral lung lesions. One procedure-related serious adverse event (AE) of pneumothorax resolved without sequelae, no AEs delayed first-line standard of care therapy initiation, and CTT scans at 30 days showed limited parenchymal changes around the ablation zone.

"The AFFINITY results further heighten our confidence in the Aliya PEF ablation technology," added Doug Godshall, chief executive officer of Galvanize Therapeutics in the release.¹ "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 tumors locally while also stimulating the body's immune system."

References

1. Moreno-Gonzalez A, Nafie EHO, Pastori C, et al. Six-month local control rates and immune responses after pulsed electric field ablation in metastatic cancer. Cancers. 2025;17(21):3495. doi:10.3390/cancers17213495
2. New study shows Aliya® pulsed electric field ablation achieved local control of lung tumors in metastatic cancer patients and may induce an immune response. News release. Galvanize Therapeutics. November 11, 2025. Accessed November 13, 2025. https://tinyurl.com/4vvkr9zw
3. Pritchett MA, Reisenauer JS, Fernandez-Bussy S, et al. The safety of pulsed electric field ablation before standard of care treatment for patients with metastatic cancer. J Bronchology Interv Pulmonol. 2025;32(4):e01027. 2025;32(4):e01027. doi:10.1097/LBR.0000000000001027