December 15, 2023ModernaAndMSD（MSD）Published itsmRNA Cancer VaccineThe latest clinical trial results.This involved 157 patients with advanced melanomaPhase 2b randomized clinical trial designed to evaluateModernaCompany's Cancer VaccinemRNA-4157Compared with MSD'sPD-1 Monoclonal AntibodyKeytrudaCombination TherapyHigh Risk of Surgical ResectionMelanoma(Stage III/IV)Safety and efficacy.The patient is undergoing surgery.CutExcept for treatmentAfterwards, randomly assignedmRNA-4157+Keytruda Combination Therapy(107 people)Or standalone Keytruda treatment(50 people), until cancer recurrenceOr until unacceptable toxic side effects occur.The analysis showed that within the 3-year treatment period, compared to Keytruda monotherapy, the combination of mRNA-4157 and Keytruda significantly improved patient outcomes.Relapse-Free Survival Period（RFS），The risk of recurrence or death was reduced by 49% in patients., and significantly improveDistant Metastasis-Free Survival（DMFS），The risk of distant metastasis or death was reduced by 62% in patients.。mRNA-4157The design goal of the vaccine is to stimulate an immune response by generating a T-cell response based on the mutation characteristics of the patient's tumor. In March 2023, this mRNA cancer vaccine received Breakthrough Therapy designation from the FDA.
KeytrudaDeveloped by MSD, it is an anti-PD-1 monoclonal antibody used to treat various cancers, including metastatic melanoma, non-small cell lung cancer, cervical cancer, head and neck cancer, and Hodgkin's lymphoma. It is one of the highest-selling drugs worldwide, with sales reaching $20.9 billion in 2022.(Second only to Humira's $21.2 billion)。
CEO of Moderna, Inc.Stephane BancelWhen interviewed,Moderna's mRNA Cancer Vaccine for Melanoma May Be Available in Two Years, Marking a Milestone in Combating This Most Severe Form of Skin Cancer.According to the International Agency for Research on Cancer of the World Health Organization（IARC）According to the data, in 2020, there were an estimated 325,000 new cases of melanoma globally, and 57,000 people died from this disease.Stephane Bancel, indicating thatWe believe that this mRNA cancer vaccine can receive accelerated approval for marketing in some countries before 2025.Unlike traditional vaccines, so-called therapeutic vaccinesIt is used to treat diseases rather than prevent them, but they also work by training the body's own immune system to combat incoming diseases. Nowadays,Therapeutic vaccines represent a real hope in oncology, as a “Immunotherapy 2.0”。ModernaAndMSD（MSD）The latest clinical trial results show that, compared to using aloneKeytruda，mRNA Cancer Vaccine CombinationKeytruda, for patientsThe risk of recurrence or death was reduced by 49% within three years. Data published last year showed that within two years, patients...The risk of recurrence or death was reduced by 44%. This indicates that the longer the duration, the more pronounced the advantages of combination therapy become, without an increase in the incidence of side effects.Stephane Bancel, indicating thatCompared with the best immune checkpoint blockade therapies on the market, we have managed to keep half of the patients alive, which is a significant breakthrough in the field of cancer treatment.。The existing clinical evidence has already supported the conditional approval of thismRNA CancerVaccine（mRNA-4157）Lay the foundation.It is reported that Moderna will launch a larger Phase 3 clinical trial involving 1,000 cancer patients in 2024, which may lead to conditional approval from regulatory authorities. In addition, preparations are being made for the therapy's market approval.Moderna is building a new factory in Massachusetts to meet FDA requirements and provide sufficient supply. MModerna also stated,Already LaunchedPhase 3 clinical trials of mRNA cancer vaccines for lung cancer are underway, with research on other cancer types also in progress.
https://investors.modernatx.com/news/news-details/2023/Moderna-And-Merck-Announce-mRNA-4157-V940-In-Combination-with-KeytrudaR-Pembrolizumab-Demonstrated-Continued-Improvement-in-Recurrence-Free-Survival-and-Distant-Metastasis-Free-Survival-in-Patients-with-High-Risk-Stage-IIIIV-Melanoma-Following-Comple/default.aspx
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