Merck & Moderna Launch Third Pivotal Clinical Trial of mRNA Cancer Vaccine V940 in Combination with Keytruda for Cutaneous Squamous Cell Carcinoma

Mar 14, 2024 07:59 CST Updated 08:01

MSD

Pharmaceutical R&D and Manufacturer

Moderna

mRNA Therapeutics Developer

▎WuXiEdited by Kant Content Team

Recently, information on ClinicalTrials.gov showed,MSD and Moderna Plan to Launch a Phase 2/3 Clinical Trial to Evaluate the Efficacy and Safety of the Personalized Neoantigen Vaccine mRNA-4157 (V940) in Combination with MSD’s PD-1 Inhibitor Keytruda for the Treatment of Patients with Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma.This is the third pivotal clinical trial planned after the two companies launched pivotal clinical trials using mRNA cancer vaccines to treat melanoma and non-small cell lung cancer.

In this clinical trial, patients with locally advanced cutaneous squamous cell carcinoma will receive neoadjuvant treatment with mRNA-4157 before surgery, and after surgical removal of the tumor, they will receivemRNA-4157Adjuvant therapy in combination with Keytruda. This Phase 2/3 clinical trial has an adaptive design, with the first stage being the Phase 2 clinical trial stage, expecting to recruit 600 participants, and deciding whether to proceed to the Phase 3 clinical trial stage based on predetermined data analysis results.

Moderna’s mRNA vaccine technology can integrate sequences encoding multiple neoantigens into a single synthetic mRNA molecule. The mRNA-4157 cancer vaccine, co-developed by Moderna and MSD, can encode up to 34 neoantigens.It has already demonstrated remarkable efficacy in Phase 2b clinical trials for the treatment of high-risk melanoma patients. Released in December 2023.3-Year Follow-Up ResultsDisplay,Compared with Keytruda monotherapy, the combination of mRNA-4157 and Keytruda significantly improved relapse-free survival (RFS), reducing the risk of recurrence or death by 49% (HR=0.510, 95% CI: 0.288-0.906; one-sided p=0.0095), and improved distant metastasis-free survival (DMFS), reducing the risk of distant metastasis or death by 62% (HR=0.384, 95% CI: 0.172-0.858; one-sided p=0.0077).

In addition, MSD announced today its plan to initiate clinical trials to evaluate an investigational multivalent human papillomavirus (HPV) vaccine. This HPV vaccine aims to provide broader protection against multiple HPV types. Utilizing MSD’s virus-like particle (VLP) technology, the vaccine incorporates additional VLPs to expand coverage across HPV types. The targeted HPV types have a greater impact on populations in Africa and Asia, as well as individuals of African and Asian descent. The first human trial is expected to commence in the fourth quarter of 2024.

Everyone is watching

▲To learn more about the application of cutting-edge technologies in the biopharmaceutical industry, please long press and scan the QR code above to access "WuXi Live Studio" and watch live discussions and exciting replays on related topics.

References:

[1] Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9. Retrieved March 13, 2024, from https://www.merck.com/news/merck-announces-plans-to-conduct-clinical-trials-of-a-novel-investigational-multi-valent-human-papillomavirus-hpv-vaccine-and-single-dose-regimen-for-gardasil-9/

[2] A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007). Retrieved March 13, 2024, from https://classic.clinicaltrials.gov/ct2/show/NCT06295809

[3] Third pivotal trial for Moderna’s personalised immunotherapy. Retrieved March 13, 2024, from https://www.oncologypipeline.com/apexonco/third-pivotal-trial-modernas-personalised-immunotherapy

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange purposes only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes the views mentioned. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: This article is from the content team of WuXi AppTec. Individuals are welcome to share it on their social media platforms, but unauthorized reproduction by media or organizations in any form on other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.

Share，PointLike，In View, Focusing on Global Biomedical Health Innovation