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The INTerpath-009 trial assessed a combination of V940 with pembrolizumab among individuals with stage II, IIIA, IIIB (N2) non–small cell lung cancer.
Merck and Moderna Inc announced the launch of the phase 3 randomized clinical trial, INTerpath-009 that is assessing V940 (mRNA-4157), an investigational neoantigen therapy (INT), in combination with pembrolizumab (Keytruda) among individuals with resectable stage II, IIIA, or IIIB non–small cell lung cancer (NSCLC).1
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Lung cancer remains the leading cause of cancer death globally, with around 2.4 million new cases and 1.8 million deaths in 2022. Once diagnosed with lung cancer, individuals face an overall 5-year survival rate, which only occurs in 25% of US patients. Data displayed that NSCLC accounts for 80% of all lung cancer cases.1
“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,” Marjorie Green, MD, senior vice president and head of oncology and global clinical development atMerck Research Laboratories, said in a news release.1
Resectable NSCLC is a stage of lung cancer that can be surgically treated followed by chemotherapy, depending on the stage of the cancer.2 In stages I and II, the cancer is routinely resected; in stage IIIA, only selected individuals are resectable; and in stage IIIB and IV nearly all individuals are unresectable.3
The study authors noted that as an INT, mRNA-4157 consists of a synthetic mRNA coding for up to 34 neoantigens, with its role being based on the unique mutational structure of the DNA sequence of the individual’s tumor. Additionally, individualized neoantigen therapies are made to train and activate an antitumor immune response by forming specific T-cell responses. Pembrolizumab has the role as an immunotherapy that increases the ability of the body’s immune system to detect and fight tumor cells. As an anti-programmed death receptor-1 (PD-1) therapy, pembrolizumab blocks the interaction of PD-1 with PD-L1 and PD-L2 which activates T lymphocytes, impacting tumor cells and healthy cells. The study authors noted that pembrolizumab was indicated on its own and in combination with other therapies to treat forms of NSCLC.1
The INTerpath-009 trial (NCT06077760) assessed a combination of V940 with pembrolizumab among individuals with Stage II, IIIA, IIIB (N2) NSCLC who did not achieve a pathological complete response (pCR) after being treated with neoadjuvant pembrolizumab with platinum-based chemotherapy. A total of 680 individuals were included. Following surgical resection the individuals will be randomly assigned to receive 1 mg of V940 every 3 weeks for 9 doses with 400 mg of pembrolizumab every 6 weeks up to 7 cycles or placebo with pembrolizumab.1
Trial Name: A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002) (INTerpath-002)
ClinicalTrials.gov ID: NCT06077760
Sponsor: Merck Sharp & Dohme LLC
Completion Date (Estimated): December 2035
“We are pleased to expand the INTerpath clinical trial program 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,” said Green in a news release.1
The primary end point of INTerpath-009 is disease-free survival, deemed by the time from randomized treatment to any local occurrence of new primary NSCLC. The secondary end point includes overall survival, distant metastasis-free survival, lung cancer-specific survival, safety, and quality of life, according to study authors.1
“We believe that our mRNA technology has the potential to improve the outcomes of those affected by lung cancer and together, INTerpath-002 and INTerpath-009 are designed to demonstrate this potential in early-stage lung cancer, with and without prior neoadjuvant therapy,” Kyle Holen, MD, senior vice president and head of development of therapeutics and oncology at Moderna, said in a news release.1
