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Moderna and MSD Launch Phase III Trial of mRNA-4157 Plus Keytruda for NSCLC

• Moderna and MSD have initiated a Phase III clinical trial, INTerpath-009, to evaluate mRNA-4157 (V940) in combination with Keytruda for non-small cell lung cancer (NSCLC). • The global, double-blind, randomised trial will involve 680 participants with Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pathological complete response after initial treatment. • mRNA-4157 is an investigational individualized neoantigen therapy that uses synthetic mRNA to code for up to 34 neoantigens based on the patient's tumor mutational signature. • This trial is part of a broader program exploring mRNA-4157 with Keytruda across various cancer types, including melanoma, renal cell carcinoma, and urothelial carcinoma.

Moderna and MSD have commenced a Phase III clinical trial, named INTerpath-009, to assess the efficacy and safety of mRNA-4157 (V940) in combination with Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer (NSCLC). This global, double-blind, randomised study aims to enroll 680 participants.
The trial focuses on patients with Stage II, IIIA, or IIIB (N2) NSCLC who have not achieved a pathological complete response following initial treatment. Patient enrollment is currently underway in Canada.

Rationale for the Combination Therapy

mRNA-4157 (V940) is an investigational individualized neoantigen therapy. It utilizes synthetic messenger RNA (mRNA) to code for up to 34 neoantigens. These neoantigens are selected based on the unique mutational signature found in the DNA sequence of a patient’s tumor. The combination with Keytruda, a PD-1 inhibitor, is designed to enhance the immune response against cancer cells.

Expert Commentary

Dr. Marjorie Green, Senior Vice President and Head of Oncology and Global Clinical Development at MSD Research Laboratories, stated, “While the overall survival rates for patients with non-small cell lung cancer have significantly improved in recent years, lung cancer continues to be the leading cause of cancer death worldwide.”
She further added, “We are pleased to expand the INTerpath clinical trial programme with Moderna, evaluating V940 (mRNA-4157), a promising new modality, in combination with Keytruda to pursue meaningful advances for lung cancer and bring more options to patients with earlier stages of disease, where we potentially can have the most impact.”

Broader Clinical Program

MSD and Moderna have also initiated Phase III trials evaluating mRNA-4157 (V940) with Keytruda in patients with resected high-risk melanoma and NSCLC. Earlier in the year, the companies launched a two-part Phase II/III trial for resectable cutaneous squamous cell carcinoma, a Phase II study for renal cell carcinoma, and another Phase II trial for muscle-invasive urothelial carcinoma. All these trials are intended to explore the potential of mRNA-4157 (V940) in combination with Keytruda.
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Reference News

[1]
Moderna and MSD begin trial of mRNA-4157 and Keytruda combination for lung cancer
clinicaltrialsarena.com · Oct 29, 2024

Moderna and MSD initiated a Phase III trial to evaluate mRNA-4157 (V940) with Keytruda for non-small cell lung cancer, t...

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