Merck, and Moderna, Inc., have launched INTerpath-002, a pivotal Phase 3 randomized clinical trial for a cancer vaccine. The study aims to evaluate V940 (mRNA-4157), Moderna’s investigational individualized neoantigen therapy (INT), in combination with Merck’s KEYTRUDA, an anti-PD-1 therapy, as adjuvant treatment for patients with resected Stage II or IIIA/IIIB non-small cell lung cancer (NSCLC) with nodal involvement (N2).

Global recruitment for INTerpath-002 has started, with the first patients enrolled in Australia. Dr. Marjorie Green, Merck’s Senior Vice President, emphasized the importance of new scientific developments in treating lung cancer, particularly in its earlier stages where the prognosis is more favorable. The trial combines KEYTRUDA with V940, exploring innovations for earlier stages of NSCLC.

Kyle Holen, M.D., from Moderna, highlighted the complexities involved in addressing lung cancer, with each patient’s cancer presenting unique genetic mutations. This necessitates an innovative approach to develop individualized medicines tailored to each patient’s tumor profile. Moderna believes that their individualized neoantigen therapy can be a catalyst for such innovation, potentially propelling cancer care with cancer vaccine into a new frontier.

INTerpath-002 follows INTerpath-001, another Phase 3 trial examining the combination of V940 (mRNA-4157) and KEYTRUDA in patients with resected high-risk melanoma. INTerpath-001 is actively screening across several countries and has multiple clinical sites. Plans are in place to expand the clinical development program for V940 to additional tumor types.

V940 (mRNA-4157) is an mRNA-based therapy containing a synthetic mRNA coding for up to 34 neoantigens, which are determined and produced based on each patient’s tumor DNA sequence. When administered, this therapy uses the body’s natural processes to translate and present these neoantigens, thereby training and activating an immune response specifically targeted at the patient’s unique tumor mutations. This innovative treatment aims to stimulate a potent adaptive immune response to fight cancer.

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.