Moderna (NASDAQ:MRNA) and its collaborator Merck (NYSE:MRK) have launched the pivotal phase III INTerpath-002 study, a critical evaluation of their personalized neoantigen therapy (INT) candidate, V940 (mRNA-4157), in the context of non-small cell lung cancer (NSCLC). The INTerpath-002 study will investigate the combination of V940 with Merck’s renowned immuno-oncology drug, Keytruda, compared to the administration of Keytruda alone. This adjuvant treatment is targeted at adults with completely resected Stage II, IIIA, or IIIB NSCLC, including those with nodal involvement (N2). Global recruitment for the study has commenced, with the first participants enrolled in Australia.
The primary focus of the late-stage trial is disease-free survival (DFS), while secondary endpoints encompass overall survival (OS), distant metastasis-free survival (DMFS), lung cancer-specific survival (LCSS), safety, and quality of life.
INTerpath-002 marks Moderna and Merck’s second foray into clinical studies within the INTerpath program, following the initiation of the phase III INTerpath-001 study in July. This study assesses V940 in combination with Keytruda in melanoma patients.
The decision to embark on both studies stems from the encouraging data obtained from the phase IIb KEYNOTE-942 study on the V940-Keytruda combination in melanoma, reported in the first half of 2023. This study successfully met its primary and key secondary endpoints, demonstrating a substantial benefit in combining V940 with Keytruda compared to Keytruda alone.
Moderna and Merck plan to extend the application of V940 to various other oncology indications over time.
Year to date, Moderna’s stock has experienced a 54.4% decline, in contrast to the industry’s 20.4% fall.
The collaboration between Merck and Moderna, initiated in 2016, focuses on developing and commercializing mRNA-based therapeutics to address diverse cancer types. Last year, Merck exercised its option to co-develop V940 with Moderna, and under the terms of their partnership, costs and profits are shared equally.
Diverging from conventional therapies designed for a broad patient population, INT seeks to provide tailored treatment to cancer patients. V940 is uniquely crafted for each individual based on the distinct mutational signature of their tumor.
In contrast to traditional medications, mRNA-based therapies instruct the body to produce a specific protein that aids the immune system in preventing or treating certain diseases. The success of mRNA vaccines during the COVID-19 pandemic showcased their substantial potential, generating immune responses against the virus at unprecedented levels compared to traditional vaccines.
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