Annals of thoracic surgery short reports · 2026
Study Designs for INTerpath-002 and INTerpath-009 of Adjuvant Intismeran Autogene Plus Pembrolizumab for Non-Small Cell Lung Cancer.
СтатьяНазвание и аннотация: Перевод в очереди
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Spicer Jonathan D, Peters Solange, Gainor Justin F, Chaft Jamie E, Bestvina Christine M, Lee Jay M, Marron Thomas U, Khattak Muhammad A, Ojalvo Laureen S, Banerjee Joydeep K, Wang Zheng, Deng Xuan, Shariati Nazly, Keller Steven M, Cascone Tina
Аннотация
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.
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.