Moderna has announced the results of a Phase 2b trial investigating its mRNA treatment for skin cancer, and it continues a streak of promising news. When paired with an immunotherapy, the treatment significantly reduced the risks of recurrence, metastasis and death compared to existing treatments alone, paving the way for trials against other cancers.
While mRNA research has been in progress for decades, it was greatly accelerated by the COVID-19 pandemic. Buoyed by the success of the vaccines, the companies behind them – Moderna and BioNTech – have been working to apply the technology to other diseases, with cancer a promising early target.
Known as mRNA-4157 (V940), Moderna’s melanoma drug is an individualized neoantigen therapy. Essentially, that means the drug is personally designed for each patient, by studying the unique mutational signature of the DNA sequence of their tumors. From this, the scientists develop mRNA that codes for a specific cocktail of up to 34 neoantigens that can best target that patient’s cancer, training their body’s immune system to fight it off.
The current trial enrolled 157 patients with high-risk stage III/IV melanoma to test the effectiveness of mRNA-4157 (V940). After their tumors were surgically removed, the patients were split into two groups – one that received a combo of the mRNA drug and KEYTRUDA, an immunotherapy drug from biotech company Merck, while the second group received just KEYTRUDA alone.
The trial found that at a median follow-up of three years, patients receiving both drugs had their risk of cancer recurrence or death reduced by 49% compared to those receiving just KEYTRUDA. Better yet, the risk of distant metastasis or death was reduced by 62% compared to KEYTRUDA alone.
Adverse effects were similar between arms of the study, with 25% reported for the combo treatment and 20% for immunotherapy alone. The most common of these effects were fatigue, injection site pain and chills.
Following these promising results, the combination of mRNA-4157 (V940) and KEYTRUDA has been granted Breakthrough Therapy Designation by the FDA in the US, and accepted into the Priority Medicines (PRIME) scheme by the European Medicines Agency, for the treatment of high-risk melanoma.
The phase 2b trial will continue, while a phase 3 trial is now also underway treating earlier stages of melanoma. At the same time, a phase 3 trial is being initiated to investigate the combo treatment’s effectiveness against non-small cell lung cancer, with plans to eventually extend the program to other types of tumors as well.
Source: Moderna