Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), today announced the initiation of INTerpath-009, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as adjuvant treatment for patients with resectable Stage II, IIIA or IIIB (N2) non-small cell lung cancer (NSCLC) who did not achieve a pathological complete response (pCR) after receiving neoadjuvant KEYTRUDA plus platinum-based chemotherapy. Global recruitment in INTerpath-009 has begun, and the first patients have now started enrolling in Canada.

默克公司 (NYSE: MRK)（美国和加拿大以外地区称为 MSD）和 Moderna, Inc. (Nasdaq: MRNA) 今天宣布启动 INTerpath-009，这是一项关键的 3 期随机临床试验，旨在评估 V940 (mRNA-4157)（一种研究性个体化新抗原疗法 (INT)）与默克公司的抗 PD-1 疗法 KEYTRUDA ® (pembrolizumab) 联合用于辅助治疗可切除的 II、IIIA 或 IIIB 期 (N2) 非小细胞肺癌 (NSCLC) 患者，这些患者在接受新辅助 KEYTRUDA 加铂类化疗后未达到病理完全缓解 (pCR)。INTerpath-009 的全球招募已经开始，首批患者现已在加拿大开始入组。

“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,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “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.”

默克研究实验室高级副总裁兼肿瘤学、全球临床开发负责人 Marjorie Green 博士表示：“尽管近年来非小细胞肺癌患者的总体生存率显著提高，但肺癌仍然是全球癌症死亡的主要原因。我们很高兴与 Moderna 一起扩大 INTerpath 临床试验计划，评估一种有前途的新疗法 V940 (mRNA-4157) 与 KEYTRUDA 的结合，以寻求肺癌治疗的重大进展，并为早期疾病患者提供更多选择，我们有可能在这方面发挥最大的影响。”

“We are excited to build on our ongoing collaboration with our colleagues at Merck by expanding our research efforts for patients with NSCLC,” said Kyle Holen, M.D., Moderna's senior vice president and head of development, Therapeutics and Oncology. “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.”

Moderna 高级副总裁兼治疗和肿瘤学开发主管 Kyle Holen 医学博士表示：“我们很高兴能够通过扩大针对 NSCLC 患者的研究工作，进一步加强与 Merck 同事的持续合作。我们相信，我们的 mRNA 技术有可能改善肺癌患者的治疗结果，INTerpath-002 和 INTerpath-009 旨在共同展示这种潜力，无论是在接受过还是未接受过新辅助治疗的情况下，都可以用于治疗早期肺癌。”

Ongoing clinical development programs

正在进行的临床开发项目

Merck and Moderna have initiated Phase 3 randomized clinical trials evaluating mRNA-4157 (V940) in combination with KEYTRUDA as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma (INTerpath-001, NCT05933577 ) and non-small cell lung cancer (INTerpath-002, NCT06077760 ).

默克和 Moderna 已经启动 3 期随机临床试验，评估 mRNA-4157（V940）联合 KEYTRUDA 作为切除的高危（IIB-IV 期）黑色素瘤（INTerpath-001， NCT05933577 ）和非小细胞肺癌（INTerpath-002， NCT06077760 ）患者的辅助治疗。

In 2024, Merck and Moderna also initiated a two-part Phase 2/3 randomized clinical trial evaluating mRNA-4157 (V940) in combination with KEYTRUDA as neoadjuvant and adjuvant treatment in patients with resectable locally advanced Stage II-IV (M0) cutaneous squamous cell carcinoma (INTerpath-007, NCT06295809 ), a Phase 2 randomized clinical trial evaluating mRNA-4157 (V940) in combination with KEYTRUDA as adjuvant treatment in patients with intermediate-high-risk, high-risk, or M1 no evidence of disease renal cell carcinoma (INTerpath-004, NCT06307431 ), and a Phase 2 randomized clinical trial evaluating mRNA-4157 (V940) in combination with KEYTRUDA as adjuvant treatment in patients with high-risk muscle-invasive urothelial carcinoma post-radical resection (INTerpath-005, NCT06305767 ).

2024年，默沙东和Moderna还启动了一项由两部分组成的2/3期随机临床试验，评估mRNA-4157（V940）联合KEYTRUDA作为可切除局部晚期II-IV期（M0）皮肤鳞状细胞癌患者的新辅助和辅助治疗（INTerpath-007， NCT06295809 ），一项2期随机临床试验，评估mRNA-4157（V940）联合KEYTRUDA作为中高危、高危或M1无疾病证据肾细胞癌患者的辅助治疗（INTerpath-004， NCT06307431 ），以及一项2期随机临床试验，评估mRNA-4157（V940）联合KEYTRUDA作为根治性切除术后高危肌层浸润性尿路上皮癌患者的辅助治疗（INTerpath-005， NCT06305767 ）。