In December 2023 Merck (also known as MSD) and Moderna announced the initiation of INTerpath-002, a pivotal Phase III randomised clinical trial evaluating v940 (mRNA-4157) in combination with KEYTRUDA as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). Recruitment is underway globally and the first patients have reportedly been enrolled in Australia. The trial combines Moderna’s investigational individualised neoantigen therapy (INT) and Merck’s anti-PD-1 therapy.
INTerpath-002
The trial is a global, double-blind, placebo- and active-comparator-controlled Phase III trial that will evaluate approximately 868 patients with resected Stage II, IIIA, or IIIB NSCLC. Following complete surgical resection and adjuvant chemotherapy, participants aged 18 and above will be randomised 1:1 to receive the combination or KEYTRUDA alone for roughly one year or “until disease recurrence or any of the other criteria for discontinuation of study intervention are met”.
The primary endpoint is disease-free survival (DFS). The secondary endpoints are overall survival (OS), distant metastasis-free survival (DMFS), lung cancer specific survival (LCSS), safety, and quality of life.
Meeting needs with innovation
Dr Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories, commented that lung cancer is the “leading cause of cancer death worldwide”. This demands “continued scientific advancements to help fight this disease at earlier stages when patients have the best chance for better outcomes”.
“By combining KEYTRUDA with V940 (mRNA-4157), a promising new modality, we are researching innovative new approaches for earlier stage non-small cell lung cancer.”
A constant struggle
Dr Kyle Holen, Moderna’s Senior Vice President and Head of Development, Therapeutics and Oncology, reflected that tackling lung cancer “reflects the constant struggle between medical innovation and biological complexity”.
“Each patient’s cancer presents a labyrinth of genetic mutations, driving a novel approach of individualised medicines manufactured based on the distinct molecular tumour profile.”
Dr Holen believes that an individualised neoantigen therapy can be “this catalyst for innovation”, driving us forward “towards the next frontier of cancer care”. He is “incredibly thankful” for the patients, investigators, and clinical trial sites for helping us in this mission”.
We were glad to speak to Dr Holen recently about the potential of cancer vaccines, and you can check out the interview here! For more updates on therapeutic vaccine approaches, don’t forget to subscribe to our weekly newsletters.
