© 2021 MJH Life Sciences™ and Cure Today. All rights reserved.
“With data showing a two-fold increase in disease-free survival with the vaccine alone and in combination with checkpoint inhibitors, we hope to one day change the narrative for people with melanoma — turning this disease into a chronic condition that can be treated and managed over time,” said Dr. Mark B. Faries.
A personalized vaccine has demonstrated long-term disease-free and overall survival benefits in patients with stage 3 or stage 4 melanoma at a high risk of recurrence following complete surgical resection, according to the vaccine’s manufacturer, Elios Therapeutics.
Elios recently reported final data from a prospective, randomized, double-blind, placebo-controlled phase 2b trial that evaluated the adjuvant use of the company’s personalized tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine.
Researchers developed and assessed two versions of the vaccine – one which was produced by isolating dendritic cells from 120 milliliters (ml) of a patient’s blood (vaccine-A) and one with dendritic cells isolated after a single injection of filgrastim followed by 50-70 ml of blood (vaccine-B) – in 144 patients who were then randomized to receive either version of the vaccine or placebo to prevent recurrence.
“These new data, combined with the doubled rate of disease-free survival among patients treated with the vaccine and standard-of-care checkpoint inhibitors, further strengthen our confidence that the personalized TLPLDC vaccine provides a clinically meaningful benefit for people with high-risk melanoma,” said Elios Therapeutics’ CEO Buddy Long in a company-issued press release.
When compared with vaccine-B (23.4%) and placebo (27.1%), vaccine-A (51.8%) significantly improved 36-month disease-free survival (DFS). Vaccine-A (92.9%) also significantly improved overall survival compared to vaccine-B (62.8%) and placebo (70.3%).
Additionally, improvement in disease-free survival (DFS) was seen with vaccine-A across both stage 3 (49.7% vs. 29.4%) and stage 4 (68.6% vs. 9.4%) melanoma. Adding vaccine-A to current standard-of-care checkpoint inhibitors (48.5%) also led to a significant improvement in 36-month DFS compared with checkpoint inhibitors alone (24.1%).
More than 90% of the treatment-related side effects that occurred in 34.7% of patients within the trial were minor in nature.
“To demonstrate a long-term survival benefit with low toxicity in a therapeutic is what we hope for in every clinical trial. Achieving this with an aggressive disease like melanoma offers great promise for patients,” said Dr. Mark B. Faries, co-director of the Melanoma Program at Cedars-Sinai at The Angeles Clinic and Research Institute, in the release. “With data showing a two-fold increase in disease-free survival with the vaccine alone and in combination with checkpoint inhibitors, we hope to one day change the narrative for people with melanoma — turning this disease into a chronic condition that can be treated and managed over time.”
The plan, according to the release, is to continue with a registrational phase 3 trial.
Alleviating Pandemic-Related Anxiety Over Returning to the Clinic for Clinical Trials
Areas Patients with CLL Can Focus On to Maintain Their Health Beyond Treatment
Enhertu Receives FDA Approval for Gastroesophageal, Gastric Cancer Subset
Blue Note Therapeutics Partners With Several Nonprofits, Advocacy Groups to Deliver Digital Cancer-Related Mental Health Care Amid COVID-19 Pandemic