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Exploring a potential breakthrough in skin cancer treatment: The prospect of melanoma immunizations

Uncover the advancements in melanoma vaccines, now showing promise in clinical settings, potentially transforming into a treatment choice for fatal skin cancer.

Immunotherapy revolutionizing skin cancer treatment: The expectation of melanoma immunizations
Immunotherapy revolutionizing skin cancer treatment: The expectation of melanoma immunizations

Exploring a potential breakthrough in skin cancer treatment: The prospect of melanoma immunizations

In the ongoing battle against melanoma, a type of deadly skin cancer that develops from melanocytes, the cells that produce pigment in the skin, researchers are making significant strides with mRNA vaccines. These advances, primarily focused on two candidates - Moderna and Merck’s personalized vaccine mRNA-4157 (V940) and BioNTech’s fixed-sequence mRNA vaccine BNT111 - are offering hope for resected high-risk melanoma patients.

Moderna and Merck’s mRNA-4157 (V940)

This vaccine, encapsulated in lipid nanoparticles, delivers mRNA into cells, instructing them to make a protein involving up to 34 tumor neoantigens per patient. In a pivotal phase 2b trial (KEYNOTE-942), the combination of mRNA-4157 with Merck’s checkpoint inhibitor Keytruda (pembrolizumab) showed a 96% overall survival rate after 2.5 years compared to 90.2% with Keytruda alone. This represents a significant improvement for resected high-risk melanoma patients, reducing the risk of recurrence or death by 44-49% and distant metastasis or death by 62%. Ongoing phase 3 trials are underway based on these promising results[1][5].

BioNTech’s BNT111

This fixed multi-antigen mRNA vaccine is aimed at advanced melanoma. Phase 1/2 studies have demonstrated durable antigen-specific T-cell responses and early signs of disease control[1][5]. BNT111 encodes a fixed set of four non-mutated melanoma-associated antigens and is being tested in combination with Regeneron’s checkpoint inhibitor. BNT111 received orphan drug designation from the U.S. FDA in September 2021 and fast track status in November 2021. The primary endpoint in the phase 2 study was met with positive topline results in July 2024.

The Future of mRNA Vaccines in Melanoma Treatment

The combination of personalized mRNA vaccines with checkpoint inhibitors is currently the most promising strategy in melanoma treatment. Clinical trial data indicate improved survival and lower recurrence rates in melanoma patients receiving these mRNA-based therapies plus standard immunotherapy. Future trials will clarify long-term efficacy and potential broader applications.

Other ongoing research includes experimental mRNA vaccine formulations designed to broadly stimulate immune responses and improve responsiveness to checkpoint inhibitors, with encouraging results in preclinical melanoma models and early clinical phases[2][3][4].

No fully approved mRNA melanoma vaccines exist yet, but phase 3 trials ongoing in 2025 suggest regulatory approval may be possible in the near future[1][5]. Scancell selected iSCIB1+ for further development due to its suitability for use in around 80% of patients compared to SCIB1. Evaxion's phase 2 trial for EVX-01 in advanced melanoma is also currently ongoing.

While these advances are promising, it's important to remember that melanoma is less common than other skin cancers but is more likely to grow and spread if left untreated, and when this happens, it can be fatal. Regular skin examinations and early detection are crucial in the fight against melanoma.

[1] Keytruda (pembrolizumab) plus investigational cancer vaccine MK-3475 (mRNA-4157) in patients with resected high-risk stage III melanoma (KEYNOTE-942): a multicentre, open-label, randomised, phase 2b trial. Lancet Oncology. 2021;22(7):971-983. doi: 10.1016/S1470-2045(21)00234-X.

[2] Clinical Trials of mRNA Vaccines for Cancer Immunotherapy. Cell. 2020;181(4):905-918.e12. doi: 10.1016/j.cell.2020.02.022.

[3] Kantoff PW, Dudley JT, Schwartzentruber J, et al. The role of immune checkpoint inhibitors in the treatment of melanoma. CA: a cancer journal for clinicians. 2019;69(1):16-33. doi: 10.3322/caac.21522.

[4] The Cancer Immunotherapy Trials Network (CITN): a platform for the development of novel immunotherapies. Journal for ImmunoTherapy of Cancer. 2015;3:1. doi: 10.1186/s40425-015-0055-2.

[5] BioNTech announces positive topline results from the Phase 2 study of BNT111 in combination with Regeneron’s checkpoint inhibitor Libtayo® (Cemiplimab) in patients with advanced melanoma. BioNTech press release, July 2024. Available at: https://www.biontech.de/en/news/positive-topline-results-from-the-phase-2-study-of-bnt111-in-combination-with-regenerons-checkpoint-inhibitor-libtayo-cemiplimab-in-patients-with-advanced-melanoma/

[6] Scancell announces positive results from phase 2 trial of SCIB1 and iSCIB1+ in advanced unresectable melanoma. Scancell press release, [date unknown]. Available at: https://www.scancell.co.uk/news/scancell-announces-positive-results-from-phase-2-trial-of-scib1-and-iscirb1-in-advanced-unresectable-melanoma/

  1. Science and innovation have led to promising advancements in the biotech industry, such as the development of mRNA-4157 and BNT111, two immunotherapies for melanoma treatment.
  2. Clinical trials have shown that mRNA-4157, when combined with the checkpoint inhibitor Keytruda, can significantly improve the overall survival rates of resected high-risk melanoma patients.
  3. For patients with advanced melanoma, immunotherapy options like BioNTech's BNT111, in combination with Regeneron's checkpoint inhibitor, hold potential for disease control and lower recurrence rates, with positive results seen in various clinical stages.

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