A new injectable therapy is showing positive results in throughout a five-year period.
The personalized , called intismeran autogene, combined with the cancer immunotherapy drug KEYTRUDA (pembrolizumab), is a collaboration between Merck and Moderna.
The results from the phase 2b KEYNOTE-942 study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on May 27.
After about a five-year follow-up, the combo drug was found to reduce the risk of melanoma recurrence or death by 49% compared to pembrolizumab alone.
The researchers analyzed data from 157 patients with high-risk whose cancer had been removed via surgery. The participants were split into two groups â one received the combo therapy and the other only received pembrolizumab, according to a press release.
The findings revealed that the combination group saw benefits that were “sustained and durable over time.”
Intismeran autogene is designed using mutations identified in a patients own tumor, with the intention of teaching the what the cancer looks like so that it can recognize and attack it.
According to the researchers, intismeran is “well-tolerated” with a “manageable” safety profile.Â
The most commonly cited side effects of the personalized mRNA vaccine plus KEYTRUDA were fatigue, injection-site pain, chills, fever and headache. The researchers reported no new long-term safety concerns and no severe vaccine-related adverse events.
The combination therapy is currently being evaluated in a phase 3 study â the final confirmation stage.
In a Merck press release from January, Kyle Holen, MD, Modernas senior vice president and head of development, oncology and therapeutics, noted that this data highlights the “potential of a ⦠in patients with resected high-risk melanoma.”
“We continue to invest in our platform in oncology because of encouraging outcomes like these, which illustrate mRNAs potential in cancer care,” he said. Â
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, also commented that for many patients with stage 3 or 4 melanoma, there is a “significant risk of recurrence .”
“As such, demonstrating the longer-term potential of intismeran autogene and KEYTRUDA to reduce the risk of recurrence for certain patients with melanoma is a meaningful milestone,” she said.
The company cited encouraging five-year follow-up data and pointed to upcoming late-stage INTerpath trial results with Moderna in several .
