For decades, cancer vaccines have been tested, though no real promising results have emerged. However, results of a new clinical trial involving melanoma patients are giving experts a fresh boost of optimism.
Findings from a phase 2b trial showed the combination of an experimental mRNA vaccine and the immunotherapy drug pembrolizumab, or Keytruda, reduced the risk of melanoma recurrence or death by 44 percent compared to immunotherapy alone.
The randomized trial was led by researchers at NYU Langone Health's Perlmutter Cancer Center in New York City. Among 107 participants at high risk of melanoma recurrence who received both the personalized experimental vaccine and pembrolizumab, the standard of care, about 22 percent had a recurrence during a three-year follow-up period. Among 50 participants who received only the immunotherapy drug, 40 percent had a recurrence.
For decades, cancer vaccines have failed. If these results hold up in larger studies slated to start later this year, it would mark a significant turning point, experts say.
"It's probably the first real data that suggests that this personalized approach to vaccination may be worth exploring further," Ryan Sullivan, MD, co-author on the study and oncologist at Boston-based Mass General Cancer Center, told USA Today.
The trial involved individuals who had surgery to remove melanoma from lymph nodes or other organs and were at high risk of recurrence. The experimental vaccine, developed by Moderna and Merck, teaches the body's immune system to recognize and attack cancer cells without damaging health tissue. Development of the personalized shot is based on tumor cells removed during surgery and takes about eight weeks to manufacture, experts told the news outlet.
"This represents a big shift in how we're using cancer vaccines," Robert Vonderheide, MD, program committee chair of the American Association for Cancer Research's annual meeting, where the study was presented, told USA Today. Dr. Vonderheide was not involved in the study.
Researchers anticipate a phase 3 trial to begin this summer. If similar results hold true, they anticipate it would take at least two years before data is registered with the FDA, and up to three years before the combination could be approved for use, NBC News reported.