Amivantamab Monotherapy in Chemorefractory RAS / BRAF Wild-Type Metastatic Colorectal Cancer: Results From OrigAMI-1, an Open-Label, Phase Ib/II Study

作者：Paul E. Oberstein, J. Randolph Hecht, Kanwal Raghav, Filippo Pietrantonio, Dirk Arnold, Víctor Moreno, Eric Van Cutsem, Rozita Abdul Malik, Yong Sang Hong, Myung Ah Lee, Harvey Yu-Li Su, Jeeyun Lee, Sreenivasa Chandana, Marcia Cruz-Correa, Ying Yuan, Azura Ahmad, Kuan-Ming Lai, Hung‐Chih Hsu, Eric X. Chen, Elena Elez, Chia‐Chi Lin, Carlos Lopez, Hans Prenen, Susana Roselló‐Keränen, Héctor Vélez, Yu-Min Yeh, Volker Heinemann, Cathy Eng, Seung‐Hoon Beom, Sabine Tejpar, Sanjib Chowdhury, Xuesong Lyu, Medha Kamat, Joshua C. Curtin, Bharvin Patel, John Xie, Rianka Bhattacharya, Robert W. Schnepp, Emrullah Yilmaz, Ryota Iwasawa, Mahesh Daksh, Patricia Lorenzini, Meena Thayu, Mahadi Baig, Han Sang Kim, Sae‐Won Han · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco-25-02187 · 被引用次数：2 · 研究领域：Colorectal Cancer Treatments and Studies、Cancer Immunotherapy and Biomarkers、Cancer Cells and Metastasis

PURPOSE: Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, is approved in non-small cell lung cancer (NSCLC). Effective treatments are limited for chemorefractory metastatic colorectal cancer (mCRC). METHODS: amplification. Participants with left-sided mCRC without (cohort A) or with (cohort B) prior anti-EGFR antibody treatment, or right-sided mCRC (cohort C) regardless of prior anti-EGFR treatment, received intravenous amivantamab 1,050 mg (1,400 mg for ≥80 kg) once every 2 weeks. The primary end point was objective response rate (ORR) per RECIST v1.1. RESULTS: By October 31, 2024, 94 participants received amivantamab monotherapy (median follow-up, 11.9 months). The median age was 60 years, and 65% of participants were male, with a median of 2 prior lines (94%, prior bevacizumab). In left-sided cohorts, the ORR was 29% (5 of 17) in cohort A and 19% (10 of 54) in cohort B; the median duration of response (DoR) was 9.0 months and 6.1 months, and the median progression-free survival (PFS) was 5.7 months and 4.6 months, respectively. In the right-sided cohort, the ORR was 22% (10 of 23; 43% had prior anti-EGFR), the median DoR was 9.8 months, and the median PFS was 3.7 months. Most frequent treatment-related grade ≥3 adverse events (AEs) were rash (7%), dermatitis acneiform (4%), and hypoalbuminemia (4%). One participant discontinued amivantamab because of a treatment-related AE. CONCLUSION: Amivantamab monotherapy demonstrated promising, durable...