Personalized Cancer Vaccine Candidate Announces Positive Phase llb Results
A Texas biopharmaceutical company announced positive top-line results from the Phase IIb clinical trial evaluating its immuno-oncology candidate, the TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine, in patients with Stage III and IV resected melanoma.
The Elios Therapeutics said in a press release, ‘This is the first positive Phase IIb study of a personalized cancer vaccine in patients with high-risk melanoma, an aggressive disease with a need for safer and more effective treatment options.’
TLPLDC is an autologous therapeutic cancer vaccine that is made from a patient’s own cells and is designed to stimulate the immune system to recognize tumor cells and fight the patient's specific cancer.
This study met its primary endpoint by demonstrating a statistically significant reduction in the risk of disease recurrence at 24-months (disease-free survival; DFS) in the per treatment (PT) population.
For all 144 patients enrolled in the study, including those who were never, or incompletely vaccinated, the recurrence rate was 66 percent in the placebo arm compared to 54 percent in the vaccine arm, representing an 18 percent clinically meaningful, though statistically non-significant, reduction in the relative risk of disease recurrence.
However, the PT analysis of all patients who completed the primary vaccine series (six-months) of TLPLDC or placebo, demonstrated a 56 percent recurrence rate in the placebo arm versus 29 percent in the vaccine arm, representing a highly statistically significant 50 percent reduction in the relative risk of disease recurrence.
The independent Data Safety Monitoring Board (DSMB) responsible for evaluating the results of the study determined that there were no safety concerns with only one-third of patients experiencing a related adverse event (AE), the majority of which were grade 1 or 2.
Furthermore, an initial assessment of 36-month follow-up data on all patients indicates that the TLPLDC vaccine benefit is not only durable but continues to show benefit beyond 24-months.
As a result, the DSMB recommended that the study continue as designed to the 36-month landmark endpoints of DFS and overall survival, anticipated in June 2020.
The TLPLDC (tumor lysate, particle-loaded, dendritic cell) vaccine is a unique type of immunotherapy, both in how it is made and how it is delivered. The vaccine is personalized, meaning it is made from a patient's tumor and blood.
Every patient's tumor has a unique antigenic profile unlike any other, and dendritic cells found in the blood are the most potent antigen-presenting cells in the body.
Once TLPLDC is administered, it delivers the patient's complete repertoire of tumor antigens to the immune system, creating a dual innate and adaptive immune response, activating fighter T cells, and triggering the immune system to recognize, and seek out and destroy any cells containing the antigens and specific mutations from their tumor.
"As a treating physician, substantially reducing the risk of cancer from returning is a high priority for me and my patients. To be able to create a customized vaccine using a patient's own tumor that can immunize them against their cancer is an exciting possibility," said Mark B. Faries, M.D., co-director of the Melanoma Program and head of Surgical Oncology at The Angeles Clinic and Research Institute.
"We believe the results from this trial support advancing the TLPLDC clinical program to a Phase III trial."
Melanoma is less common than some other types of skin cancer, but it is more likely to grow and spread. When diagnosed and treated at an early stage, it has a high cure rate.
However, patients with later stages of the disease carry a high risk for melanoma recurrence because some melanoma cells can remain in the body, even after surgery. In the U.S, the incidence of melanoma was 91,270 estimated new cases and 9,320 related deaths in 2018, reported a recent study.
"Despite advances in the treatment of metastatic melanoma, there remains a need for therapeutic innovations that further reduce the risk of the disease returning," said Kyleigh LiPira, M.B.A, chief executive officer of the Melanoma Research Foundation (MRF).
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Historically, autologous cancer vaccines have been rather onerous to develop, sometimes taking months between the tumor biopsy and administration.
Elios has simplified the process so the time from resection to injection is approximately two weeks. This makes the vaccine highly feasible and will ultimately be easy for community and academic oncologists to adopt into their practices.
The TLPLDC vaccine is currently being studied as a monotherapy and in combination with standard-of-care checkpoint inhibitor therapies in a Phase IIb clinical trial for the treatment of late-stage melanoma at leading academic cancer centers in the United States.
Elios Therapeutics, LLC, is a biopharmaceutical company developing a portfolio of innovative personalized therapeutic cancer vaccines targeting unmet medical needs across a broad range of tumor types.