Merck & Co Inc. (NYSE: MRK) moves up in pre trading session on Wednesday as the firm in a mid-stage study, an investigational tailored melanoma vaccination created by Moderna Inc combined with Merck & Co Inc.’s (NYSE: MRK) blockbuster immunotherapy Keytruda reduced the chance of skin cancer recurrence or death by 44% compared to Keytruda alone.
The study is the first to show that combining mRNA vaccine technology – which has been used to generate effective COVID-19 vaccines – with a medication that boosts the immune response improves outcomes for individuals with the most lethal kind of skin cancer.
The findings were praised as extraordinary by the firms.
“It’s a great stride forward in immunotherapy,” said Eliav Barr, Merck’s chief medical officer and head of worldwide clinical development.
In a separate interview, Moderna’s chief medical officer, Paul Burton, stated that the combination “has the potential to represent a new paradigm in the treatment of cancer.”
The current trial included 157 patients with stage III/IV melanoma who had their tumors surgically excised before being treated with the drug/vaccine combination or Keytruda alone to postpone disease recurrence.
After a year of treatment, the combination was typically safe and demonstrated a statistically significant effect when compared to Keytruda alone. Serious drug-related adverse events were reported in 14.4% of patients who received the drug-vaccine combination, compared to 10% of individuals who received Keytruda alone.
Merck exercised an option in October to jointly develop and market the medication, known as mRNA-4157/V940, splitting expenses and earnings evenly. Merck and Moderna want to discuss the findings with regulatory authorities before beginning a phase 3 trial in melanoma patients in 2023.
The Merck/Moderna cooperation is one of several that combine potent medications that activate the immune system with mRNA vaccination technology to target malignancies. These neoadjuvant vaccinations are intended to attack highly modified cancers.
The tailored vaccination works in tandem with Merck’s Keytruda, a checkpoint inhibitor meant to block a protein known as programmed death 1, or PD-1, which aids cancers in evading the immune system.
To create the vaccine, researchers collected tumor and healthy tissue samples from patients. After decoding the samples’ genetic sequences and isolating mutant proteins linked solely with cancer, the knowledge was utilized to build a cancer vaccine. When a patient’s cells are injected, they operate as a manufacturing plant, making exact copies of the mutations for the immune system to detect and kill.
Moderna’s tailored vaccination can be created in roughly eight weeks, a period Burton intends to reduce in the future. Assuming the deal is finally authorized, he said Moderna will need to conduct a “huge scale-up” of its production capabilities and that firm is “all in”.
Barr said the companies intend to study the approach in other types of highly mutated cancers, such as lung cancer. Other highly mutated cancers include bladder cancers and some triple negative breast cancers.