New Therapy Shows Promise for Melanoma Treatment

A novel injection therapy has demonstrated encouraging results in the fight against melanoma over a five-year span. This treatment, known as Intismeran Autogene, pairs personalized mRNA with the immunotherapy drug Keytruda (pembrolizumab). It’s a result of collaborative efforts between Merck & Co. and Moderna.

The findings from the phase 2b KEYNOTE-942 trial were shared at the recent American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago on May 27.

Following a follow-up of around five years, the combination therapy was found to cut the risk of melanoma recurrence or death by nearly 49% compared to using pembrolizumab alone.

The study involved 157 patients diagnosed with high-risk stage 3 and 4 melanoma who had undergone surgical removal of their tumors. Participants were split into two groups: one received the combination therapy while the other was treated with pembrolizumab by itself, as detailed in a press release.

The results indicated that those in the combination group experienced “long-lasting and durable” effects.

Intismeran is engineered using mutations found in a patient’s tumor, with the aim of educating the immune system so it can identify and combat cancer cells.

According to researchers, Intismeran is generally well-tolerated and features a “manageable” safety profile. The most frequent side effects reported from the combination of the personalized mRNA vaccine and Keytruda included fatigue, pain at the injection site, chills, fever, and headaches. Notably, there were no new long-term safety concerns or serious adverse effects linked to the vaccine.

This emerging therapy is currently undergoing evaluation in a phase 3 confirmatory trial.

In a statement from Merck in January, Kyle Whalen, MD, who oversees oncology and therapeutics development at Moderna, emphasized that the data point to a promising long-term benefit for patients with resected high-risk melanoma.

“These results are quite encouraging as they showcase the potential of mRNA in advancing cancer treatment,” he remarked.

Dr. Marjorie Green, senior vice president at Merck Research Laboratories, added that many patients with stage 3 or 4 melanoma face significant risks of cancer returning after surgery. She affirmed, “Thus, showing the long-term effectiveness of combining endotismelan autologous gene with Keytruda in reducing recurrence risks is indeed an important achievement.”

The company highlighted the encouraging five-year data and also noted upcoming trials, like the INterpath trial, which will address several challenging cancer types.