Amivantamab in Recurrent/Metastatic Head and Neck Squamous Cell Cancer After Checkpoint Inhibitor and Chemotherapy: Pivotal Results From the Phase Ib/II OrigAMI-4 Study
Abstract
Single-agent paclitaxel or cetuximab after immune checkpoint inhibitor (ICI) and chemotherapy demonstrated objective response rates (ORRs) of 21%-24% in recurrent/metastatic (R/M) head/neck squamous cell cancer (HNSCC). Epidermal growth factor receptor (EGFR) and MET are overexpressed in R/M HNSCC. Amivantamab, an EGFR-MET bispecific antibody, may be a rational treatment. Cohort 1 of OrigAMI-4 (ClinicalTrials.gov identifier: NCT06385080 ) evaluated subcutaneous amivantamab administered every 3 weeks in participants with non-human papillomavirus R/M HNSCC after PD-(L)1 inhibitor and platinum-based chemotherapy. Prior anti-EGFR therapy and p16-positive oropharyngeal cancer were exclusionary. The primary end point was RECIST v1.1 ORR. Secondary end points included duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. In 102 participants, blinded independent central review‑assessed ORR was 42% (95% CI, 32 to 52); the complete response rate was 15%. Median DoR was not reached (NR; 95% CI, 6.9 to NR); 56% of responses lasted ≥6 months. Investigator-assessed ORR was 47% (95% CI, 37 to 57). At a median follow-up of 11.8 months (range, 1.1-21.9), median PFS and OS were 6.8 months (95% CI, 5.2 to 8.3) and 12.5 months (95% CI, 10.2 to 16.8), respectively. Adverse events were consistent with previous experience with no new safety signals. Treatment-related discontinuations were low (8%). Amivantamab demonstrated greater antitumor activity in participants previously exposed to ICI and chemotherapy than has been reported for paclitaxel or cetuximab.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (59)
Barbara Burtness
Department of Internal Medicine and Yale Cancer Center, Yale School of Medicine, New Haven, CT
Ari J. Rosenberg
Department of Medicine, Section of Hematology and Oncology and Comprehensive Cancer Center, University of Chicago, Chicago
Paul L. Swiecicki
Jessica L. Geiger
Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH
Marc Oliva
Institut Català d’Oncologia L’Hospitalet, Institut d’Investigació Biomèdica de Bellvitge, Barcelona
Xuesong Lyu
Johnson & Johnson, Shanghai, China
Joshua C. Curtin
Johnson & Johnson, Spring House, PA
Kiichiro Toyoizumi
Johnson & Johnson, Tokyo, Japan
John Xie
Johnson & Johnson, Raritan, NJ
Mark Wade
Brooke Diorio
Johnson & Johnson, Titusville, NJ
Aastha Kapoor
Johnson & Johnson, Spring House, PA
Emrullah Yilmaz
Johnson & Johnson, Raritan, NJ
Mahadi Baig
Johnson & Johnson, Raritan, NJ
Priya Kim
Johnson & Johnson, Spring House, PA
Remy B. Verheijen
Johnson & Johnson, Leiden, the Netherlands
Sujay Shah
Johnson & Johnson, Spring House, PA
Kevin J. Harrington
Institute of Cancer Research, Royal Marsden Hospital, London
Cyril Abdeddaim
Douglas Adkins
Robert Ebert and Greg Stubblefield Head and Neck Tumor Center at Washington University School of Medicine, Alvin J. Siteman Cancer Center, and Barnes–Jewish Hospital, St. Louis
Myung-Ju Ahn
Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Aarti Bhatia
Irene Braña
Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona
Benoit Calderon
Institut Sainte Catherine, Avignon, France
Martin Forster
Jessica Geiger
1Cleveland Clinic, Cleveland, United States
Ye Guo
Dennis Hahn
Department of Hematology, Oncology, Stem-Cell Transplantation, and Palliative Care, Klinikum Stuttgart, Stuttgart, Germany
Missak Haigentz
Kevin Harrington
Lara Iglesias
William Ince
Addenbrooke's Hospital, Cambridge, United Kingdom
Dongmei ji
Shigenori Kadowaki
Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan
Andrzej Kawecki
Bhumsuk Keam
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea
Kathleen Kerrigan
Sung-Bae Kim
Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
Shau-Hsuan Li
Department of Hematology-Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
Sun Min Lim
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea
Jin-Ching Lin
Lei Liu
Jessica McDermott
Robert Metcalf
The Christie NHS Foundation Trust, Manchester, United Kingdom
Ewa Pawlowska
Ari Rosenberg
Tomasz Rutkowski
Maria Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Gliwice, Poland
Malwinder Sandhu
Nisha Mohd Shariff
Siddharth Sheth
Division of Oncology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC
Alexander Spira
NEXT Oncology Virgina, Virgina Cancer Specialists Research Institute, Fairfax
Ammar Sukari
Karmanos Cancer Institute, Detroit, MI
Paul Loren Swiecicki
Hideki Tanaka
Institute for Aqua Regeneration (ARG), Shinshu University, 4−17−1 Wakasato, Nagano 380-8553, Japan
Caroline Viala
Zara Vidales
Hung-Ming Wang
Muh-Hwa Yang
Division of Medical Oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan
Kunyu Yang