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Vaccine shows promise in high-risk melanoma patients

OCTOBER 23, 2018
Clinical Congress Daily Highlights, Tuesday First Edition


A personalized cancer vaccine derived from autologous tumor lysate, particle-loaded, dendritic cells (TLPLDC) was associated with improved outcomes in a subgroup of patients with advanced resected melanoma, a new study concludes.

Surgery is a mainstay of melanoma treatment. However, for late-stage disease, recurrence is high. As melanoma is a very immunogenic cancer, it’s an attractive target for cancer vaccines. Dendritoma vaccines have shown early success in melanoma patients, but they are very expensive and labor intensive to develop. John Myers, MD, San Antonio Military Medical Center, San Antonio, TX, explained how his team developed the TLPLDC vaccine to address these issues.

To make the vaccine, a patient’s dendritic cells are harvested from tumor lysate and inoculated with empty yeast cell wall particles, which are highly immunogenic and can induce an immune response when the vaccine is administered to patients. Impressively, the process can be completed in 48 hours with as little as one milligram of tumor tissue.

Dr. Myers shared interim results from an ongoing Phase IIb trial evaluating the TLPLDC vaccine in patients with stage III/IV resected melanoma. A total of 120 patients were randomized 2:1 to receive TLPLDC (n=83) or placebo (n=37) respectively, with inoculations given at 0, 1, 2, 6, 12, and 18 months. The primary endpoint was disease-free survival (DFS) at 24 months, and the vaccine was administered within three months of completion of standard-of-care therapies.

At six months, a survival analysis was performed on the intention-to-treat (ITT) and per treatment (PT) populations, the latter which excluded recurrences during the primary vaccine series six months into treatment. In the ITT group, TLPLDC vaccination was associated with improved median DFS in patients without ulceration (9.4 [n=24] vs 7.8 months [n=4], p=0.031). In the PT analysis, TLPLDC was associated with improved median DFS in the following subgroups: absent ulceration (13.1 [n=13] vs 10.2 months [n=2], p=0.002), stage IV disease (13.4 [n=8] vs 8.5 months [n=6], p less than 0.001), T4 disease (19.3 [n=6] vs 9.0 mos [n=5], p=0.001), and pooled T stages T3/4 (18.3 [n=12] vs 8.4 months [n=8], p=0.016).

“Our TLPLDC vaccine is associated with improved median disease free survival in patients who completed the primary vaccine series. The subgroup analysis revealed that certain patients with high-risk disease seem to get the most benefit, specifically those with resected stage IV disease,” Dr. Myers explained.

While the current study is limited by small subgroups and limited follow-up, he said that the researchers are looking at patient subgroups to better understand the patients that derive the most benefit from the vaccine.

“These results will help inform the Phase III trial design, which will likely need to administer the vaccine in combination with a checkpoint inhibitor per current standard of care,” he concluded.

To view this study’s abstract, click here.

Additional Information:

The Scientific Forum, A Subgroup Analysis of the Interim Results of a Prospective, Randomized, Double Blinded, Placebo Controlled, Phase IIb Trial of the Autologous TLPLDC Vaccine in Stage III/IV (Resected) Melanoma Patients to Prevent Recurrence, was held October 23, at the 2018 Clinical Congress of the American College of Surgeons in Boston, MA. Program, webcast and audio information is available at facs.org/clincon2018.


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