A new dawn in cancer therapy? Moderna and Merck have sparked excitement with their phase 2b clinical trial results, showcasing a combination mRNA vaccine and immunotherapy drug that significantly reduces melanoma recurrence risk. While not definitive, these mid-term findings suggest a potentially game-changing approach in the fight against this aggressive skin cancer.
Halving the Relapse Threat: The KEYNOTE-942 trial involved patients with high-risk melanoma who underwent surgery. Those receiving Moderna's mRNA-4157 (V940) alongside Merck's pembrolizumab drug (KEYTRUDA) enjoyed a 49% lower risk of recurrence or death compared to pembrolizumab alone. This translates to a significant improvement in recurrence-free survival, offering patients a more optimistic outlook.
Beyond Recurrence: The combined therapy also shines in preventing distant metastasis, the spread of cancer to other organs. The risk of developing distant metastasis or death dropped by 62% in the combination group compared to pembrolizumab alone. This additional benefit strengthens the case for this innovative treatment strategy.
Encouraging Safety Profile: Reassuringly, the combined treatment didn't exhibit significantly more side effects than pembrolizumab alone. The frequency of severe adverse events (grade 3 or higher) was similar between the groups, and the most common side effects were manageable, such as fatigue, injection site pain, and chills.
Fast-Track Recognition: These promising results haven't gone unnoticed. Both the US Food and Drug Administration and the European Medicines Agency have granted breakthrough therapy designations to the mRNA-4157/pembrolizumab combination for high-risk melanoma. This recognition expedites the development and review process, potentially bringing this treatment to patients sooner.
Phase 3: The Next Frontier: Building on the success of phase 2b, a larger phase 3 trial is already underway, enrolling more patients and further solidifying the evidence for this promising approach. Moderna's CEO, Stéphane Bancel, even envisions an mRNA vaccine for melanoma being available as early as 2025, a testament to the rapid advancements in this field.
SOURCE: Medscape
Moderna CEO talks skin cancer vaccine: It's a big deal for melanoma patients
REFERENCE
Dimitrios Bafaloukos et al, Evolution and Progress of mRNA Vaccines in the Treatment of Melanoma: Future Prospect, Vaccines (Basel) . 2023 Mar 13;11(3):636.
mRNA Vaccine Slows Melanoma Recurrence, Cancer Disco. 2023 Jun 2;13(6):1278.
