Merck and Moderna Initiate Phase III Study of mRNA-4157 and Keytruda Combination for Non-Small Cell Lung Cancer
The INTerpath-009 clinical trial will evaluate the combination as adjuvant treatment for patients with NSCLC who previously received neoadjuvant Keytruda plus platinum-based chemotherapy.
Merck and Moderna have announced the initiation of a Phase III clinical trial evaluating V940 (mRNA-4157) in combination with Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer (NSCLC). The first patients for the study are currently enrolling in Canada with global recruitment underway as well.1
The newly initiated trial, INTerpath-009, will evaluate the mRNA-4157-Keytruda combination as adjuvant treatment for patients with NSCLC who did not achieve a pathological complete response (pCR) after receiving neoadjuvant Keytruda plus platinum-based chemotherapy.
INTerpath-009 is a global, randomized, double-blind trial. The planned enrollment is 680 patients, who will receive either mRNA-4157 and Keytruda or placebo. The primary endpoint is disease-free survival with secondary endpoints including overall survival, safety, and quality of life.
In a press release, Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories 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 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.”
Kyle Holen, MD, senior vice president and head of development, therapeutics and oncology at Moderna added, “We are excited to build on our ongoing collaboration with our colleagues at Merck by expanding our research efforts for patients with NSCLC,” said. “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.”
Earlier in June, Merck and Moderna shared 3-year data from the KEYNOTE-942/mRNA-4157-P201 study, a Phase IIb trial that is also evaluating mRNA-4157 in combination with Keytruda, in patients with resected high-risk melanoma.2
Data showed adjuvant treatment with the combination continued to demonstrate a clinically meaningful and durable improvement in recurrence-free survival, reducing the risk of recurrence or death by 49% compared with Keytruda alone. Additionally, the duo demonstrated a meaningful improvement in distant metastasis-free survival.
"We are encouraged by the latest results from the KEYNOTE-942/mRNA-4157-P201 study. These data highlight the sustained benefit in RFS and DMFS of mRNA-4157 (V940) as adjuvant treatment in combination with Keytruda in people with resected high-risk melanoma. Importantly, this benefit was observed across various patient exploratory subgroups, reflecting the potential of mRNA-4157 (V940) for a broad range of these patients," Holen said in an earlier press release. "These findings reinforce our commitment to advancing this innovative treatment in collaboration with Merck, and we are dedicated to harnessing mRNA technology to potentially transform cancer therapy and improve patient outcomes."
References
1. Merck and Moderna Initiate Phase 3 Trial Evaluating Adjuvant V940 (mRNA-4157) in Combination with KEYTRUDA® (pembrolizumab) After Neoadjuvant KEYTRUDA and Chemotherapy in Patients With Certain Types of Non-Small Cell Lung Cancer (NSCLC). News release. Moderna. October 28, 2024. Accessed October 29, 2024. https://news.modernatx.com/news/news-details/2024/Merck-and-Moderna-Initiate-Phase-3-Trial-Evaluating-Adjuvant-V940-mRNA-4157-in-Combination-with-KEYTRUDA-pembrolizumab-After-Neoadjuvant-KEYTRUDA-and-Chemotherapy-in-Patients-With-Certain-Types-of-Non-Small-Cell-Lung-Cancer-NSCLC/default.aspx
2. Moderna & Merck Announce 3-Year Data For mRNA-4157 (V940) in Combination With KEYTRUDA(R) (pembrolizumab) Demonstrated Sustained Improvement in Recurrence-Free Survival & Distant Metastasis-Free Survival Versus KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection. News release. Moderna. June 3, 2024. Accessed October 29, 2024. https://news.modernatx.com/news/news-details/2024/Moderna--Merck-Announce-3-Year-Data-For-mRNA-4157-V940-in-Combination-With-KEYTRUDAR-pembrolizumab-Demonstrated-Sustained-Improvement-in-Recurrence-Free-Survival--Distant-Metastasis-Free-Survival-Versus-KEYTRUDA-in-Patients-With-High-Risk-Stage-IIIIV/default.aspx
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