Moderna and MSD have initiated a Phase III clinical study to evaluate mRNA-4157 (V940), an investigational individualised neoantigen therapy, in combination with Keytruda to treat non-small cell lung cancer (NSCLC).

INTerpath-009 is a global, double-blind, randomised trial that will involve 680 participants.

The trial is targeting patients with Stage II, IIIA or IIIB (N2) NSCLC who failed to achieve a pathological complete response after initial treatment.

Patient enrolment for the trial is currently underway in Canada.

MSD Research Laboratories oncology and global clinical development senior vice-president and head Dr Marjorie Green said: “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.

“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.”

mRNA-4157 (V940) is an investigational therapy that uses 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 tumour.

MSD and Moderna have also begun Phase III trials assessing mRNA-4157 (V940) with Keytruda in patients with resected high-risk melanoma and NSCLC.

Earlier this 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.

Moderna recently began a Phase III trial of its norovirus vaccine candidate, mRNA-1403, in the UK.