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Der erste mRNA-Impfstoff gegen Melanome?

von NFI Redaktion

Moderna and Merck have presented promising results from their clinical phase 2b study, investigating a combination of a messenger RNA (mRNA) vaccine and a cancer medication for the treatment of melanoma.

Will mRNA revolutionize the world of cancer treatment? This is certainly what Moderna seems to be thinking. The pharmaceutical company has released the results of a phase 2b study on the combination of its mRNA vaccine (mRNA-4157 [V940]) with Merck’s cancer medication KEYTRUDA. Although these are not the final results, but rather midterm data from the 3-year follow-up study, they are quite promising. The randomized clinical study KEYNOTE-942/mRNA-4157-P201 involved patients with high-risk melanoma (Stage III/IV) after complete resection.

Reduced risk of recurrence by half

Treatment with mRNA-4157 (V940) in combination with Pembrolizumab resulted in a clinically significant improvement in recurrence-free survival and reduced the risk of recurrence or death by 49% compared to Pembrolizumab alone. The combination of mRNA-4157 (V940) with Pembrolizumab also showed a significant improvement in distant metastasis-free survival and reduced the risk of developing distant metastases or dying by 62% compared to Pembrolizumab alone. „The KEYNOTE-942/mRNA-4157-P201 study was the first evidence of the efficacy of an mRNA cancer treatment in a randomized clinical trial and the first combination therapy to show significant benefit over Pembrolizumab alone in adjuvant melanoma,“ said Kyle Holen, MD, Senior Vice President of Moderna, after presenting these results.

Side Effects

The combined treatment also showed no major side effects compared to Pembrolizumab alone. The number of patients reporting treatment-related adverse events of grade 3 or higher was similar in the arms (25% for mRNA-4157 [V940] with Pembrolizumab vs. 20% with KEYTRUDA alone). The most common adverse events of any grade attributable to mRNA-4157 (V940) were fatigue (60.6%), injection site pain (56.7%), and chills (49%). Based on data from the phase 2b study KEYNOTE-942/mRNA-4157-P201, the US Food and Drug Administration and the European Medicines Agency have granted mRNA-4157 (V940) breakthrough therapy status and recognition under the Priority Medicines program in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma.

Phase 3 Study

In July, Moderna and Merck announced the initiation of a phase 3 study to evaluate „mRNA-4157“ [V940] in combination with Pembrolizumab as adjuvant treatment in patients with high-risk melanoma [Stages IIB-IV]. Stéphane Bancel, CEO of Moderna, believes that an mRNA vaccine for melanoma could be available by 2025.

Other Cancer Vaccines

Moderna is not the only company aiming to develop a cancer vaccine. In May, BioNTech proposed a phase 1 clinical trial for a vaccine against pancreatic cancer in collaboration with Roche Nature. In June, Transgene presented its findings on its viral vector vaccines against head and neck cancers and HPV-related cancers at the American Society of Clinical Oncology conference. And in September, Ose Immunotherapeutics made headlines with its vaccine for advanced lung cancer.

This article was translated by Univadis Francepart of the professional network Medscape.

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