What's Happening?
Moderna's mRNA-based vaccine, mRNA-4157, has demonstrated a 49% reduction in the risk of disease progression or death in patients with high-risk melanoma, according to long-term follow-up data from a phase
2b trial. The vaccine, developed in collaboration with Merck's PD-1 inhibitor Keytruda, targets 34 cancer neoantigens and is designed to prime the immune system to attack tumor cells. The KEYNOTE-942 study compared the combination of mRNA-4157 and Keytruda against Keytruda alone in patients with stage III/IV melanoma after complete surgical removal of the tumor. The five-year data shows the durability of the response, with a similar 49% improvement in progression-free survival at around three years' follow-up. Moderna had initially hoped to file for accelerated approval of the vaccine, but the FDA required completion of a phase 3 program before proceeding.
Why It's Important?
The promising results of mRNA-4157 could significantly impact the treatment landscape for melanoma, a type of skin cancer with a high risk of recurrence. If approved, the vaccine could command multibillion-dollar sales and unlock the broader potential of Moderna's mRNA-based neoantigen vaccine pipeline, which includes trials targeting lung, kidney, and bladder cancer. The development of mRNA-4157 highlights the potential of personalized cancer vaccines to improve patient outcomes by targeting specific cancer neoantigens. This advancement could pave the way for more effective and tailored cancer treatments, offering hope to patients with limited options.
What's Next?
Moderna and Merck are awaiting the results of the phase 3 INTerpath-001 trial in melanoma, expected later this year, as well as other readouts from ongoing phase 2 and 3 trials in solid tumors. The companies aim to demonstrate the vaccine's efficacy and safety in a larger patient population, which could lead to regulatory approval and commercialization. The success of mRNA-4157 could also encourage further investment in mRNA-based therapies for various cancers, potentially transforming the oncology field.
