Elios Therapeutics has reported positive findings from a Phase IIb clinical trial of its investigational TLPLDC vaccine in stage III and IV resected melanoma patients.

The tumour lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is a personalised immunotherapy formulated using a patient’s tumour and blood.

The therapeutic is intended to trigger a dual innate and adaptive immune response with the activation of T cells, stimulating the immune system to kill cells containing antigens and tumour mutations.

TLPLDC was compared to placebo in a total of 144 patients during the study.

The primary endpoint of the prospective, randomised, double-blind, placebo-controlled trial is two-year disease-free survival (DFS), while secondary endpoints include DFS at 36 months and overall survival.

According to the top-line data, the primary endpoint was met with a statistically significant decrease in the risk of disease recurrence at 24 months in the per treatment (PT) population.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Primary analysis revealed a 29% recurrence rate in the vaccine group of the population, compared to 56% in the placebo arm. This demonstrates a statistically significant 50% reduction in the relative disease recurrence risk.

However, analysis of the PT and intent-to-treat (ITT) populations revealed an 18% clinically meaningful, but statistically non-significant, decrease in the relative risk.

Safety analysis found that one-third of participants experienced a related adverse event (AE).

Data from a 36-month follow-up of all patients showed durable vaccine benefit that sustained beyond 24 months.

Based on these positive findings, the Phase IIb trial will continue to the 36-month endpoints of DFS and overall survival. These results are expected to be available in June next year.

Elios Therapeutics CEO Buddy Long said: “This is the first positive Phase IIb study of a personalised cancer vaccine in patients with high-risk melanoma, an aggressive disease with a need for safer and more effective treatment options.

“We believe the results from this trial support advancing the TLPLDC clinical programme to a Phase III trial.”