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Publications

Journal Article Epublish 1 citation

PubMed: 42719123 DOI: 10.1016/j.atssr.2026.03.009

Study Designs for INTerpath-002 and INTerpath-009 of Adjuvant Intismeran Autogene Plus Pembrolizumab for Non-Small Cell Lung Cancer.

Ann Thorac Surg Short Rep 4(3):903-908

Authors: Jonathan D Spicer, Solange Peters, Justin F Gainor, Jamie E Chaft, Christine M Bestvina, Jay M Lee, Thomas U Marron, Muhammad A Khattak, Laureen S Ojalvo, Joydeep K Banerjee, Zheng Wang, Xuan Deng, Nazly Shariati, Steven M Keller, Tina Cascone

Affiliations

  • McGill University Health Centre, Montreal General Hospital, Montreal, Quebec, Canada.
  • Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
  • Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts.
  • Thoracic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Department of Medicine, Weill Cornell Medical College, New York, New York.
  • Section of Hematology and Oncology, Department of Medicine, University of Chicago, Chicago, Illinois.
  • Division of Thoracic Surgery, Department of Surgery, David Geffen School of Medicine at University of California, Los Angeles, California.
  • Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
  • One Clinical Research and Edith Cowan University, Perth, Western Australia, Australia.
  • Moderna, Inc. Cambridge, Massachusetts.
  • Merck & Co. Inc. Rahway, New Jersey.
  • Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Abstract

BACKGROUND

Neoantigens are immunogenic molecules arising from patient-specific tumor mutations. Intismeran autogene (intismeran; formerly V940, mRNA-4157), an mRNA-based individualized neoantigen therapy (INT) encoding ≤34 neoantigens unique to each patient's tumor, is designed to promote an antitumor immune response. In early-phase studies, adjuvant intismeran plus pembrolizumab showed antitumor activity with solid tumors. Standard-of-care therapy for non-small cell lung cancer (NSCLC) tumors ≥4 cm includes platinum-based chemotherapy and pembrolizumab given after (adjuvant) or both before and after (perioperative) surgical resection. We describe study designs for the INTerpath-002 and INTerpath-009 studies evaluating the addition of intismeran to adjuvant pembrolizumab-based therapy in stage II-IIIB (N2) NSCLC.

METHODS

INTerpath-002 and INTerpath-009 are randomized, double-blind, phase 3 trials. Eligible participants for INTerpath-002 have completely resected, margin-negative, stage II-IIIB (N2) NSCLC (American Joint Committee on Cancer staging manual, eighth edition) and have received 1 to 4 cycles of adjuvant platinum-based chemotherapy. Eligible participants for INTerpath-009 have resectable stage II-IIIB (N2) NSCLC and have received ≤4 cycles of neoadjuvant pembrolizumab plus chemotherapy every 3 weeks. Participants with tumors that do not achieve a pathologic complete response, per pathologic examination of the resected tumor specimen, and have R0-R1 resection are eligible for randomized treatment. In both studies, participants are randomized 1:1 to receive pembrolizumab intravenously every 6 weeks plus either intismeran intramuscularly every 3 weeks or placebo. The primary endpoint in both studies is disease-free survival per investigator.

RESULTS

Recruitment is ongoing for both studies.

CONCLUSIONS

Results from these studies will provide insight into the potential role of INT in NSCLC.

MeSH

Cells, Lung, Neoplasms, Carcinoma, Non-Small-Cell Lung, Drug Therapy, Lung Neoplasms, Small Cell Lung Carcinoma, Therapeutics, Chemotherapy