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Subcutaneous versus Intravenous Amivantamab, both in Combination with Lazertinib, in Refractory EGFR-mutated NSCLC: Primary Results from the Phase 3 PALOMA-3 Study

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机构： [1]Princess Margaret Cancer Centre, Toronto, Canada [2]Internal Medicine III, Wakayama Medical University, Wakayama, Japan [3]Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea [4]Jilin Cancer Hospital, Changchun, China [5]Drug Development Unit, The Royal Marsden Hospital and The Institute of Cancer Research, Sutton, UK [6]Division of Hematology and Oncology, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA [7]Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR, USA [8]Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan [9]Harbin Medical University Cancer Hospital, Harbin, China [10]Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia [11]Alicante University Dr. Balmis Hospital, ISABIAL, Alicante, Spain [12]Virginia Cancer Specialists, Fairfax, VA, USA [13]Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea [14]Fudan University Shanghai Cancer Center, Shanghai, China [15]Sichuan Cancer Hospital, Sichuan, China [16]Shengjing Hospital of China Medical University, Liao Ning Sheng, China [17]Department of Oncology, University of Turin, S. Luigi Gonzaga Hospital, Orbassano (TO), Italy [18]Department of Respiratory Medicine, Fujita Health University School of Medicine, Aichi, Japan [19]Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan [20]British Hospital of Buenos Aires – Central British Hospital, Buenos Aires, Argentina [21]Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel [22]National Cancer Center, Goyang, Republic of Korea [23]Medical University of South Carolina, Charleston, SC, USA [24]Cancer Research SA, Adelaide, Australia [25]Medical Oncology Department, Vall d’Hebron Barcelona Hospital Campus, Vall d’Hebron Institute of Oncology (VIHO), Universitat Autonoma de Barcelona, Barcelona, Spain [26]Department of Radiotherapy and Oncology, Sarawak General Hospital, Kuching, Sarawak, Malaysia [27]Siriraj Hospital, Faculty of Medicine, Mahidol University Bangkok Noi Campus, Bangkok, Thailand [28]Department of Thoracic Medicine, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan [29]Núcleo de Ensino e Pequisa, Instituto Brasileiro de Controle do Câncer, São Paulo, Brazil [30]University Hospital of Giessen and Marburg, Giessen and Marburg, Germany [31]Aix Marseille University, APHM, INSERM, CNRS, CRCM, Hôpital Nord, Multidisciplinary Oncology and Therapeutic Innovations Department, Marseille, France [32]Medical Oncology, Hospital CUF Descobertas, Lisboa, Portugal [33]City of Hope National Medical Center, Duarte, CA, USA [34]Perlmutter Cancer Center, New York University Langone Health, New York, NY, USA [35]University of Michigan Rogel Cancer Center, Ann Arbor, MI, USA [36]Department of Lung Cancer and Thoracic Tumors, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland [37]Department of Medical Oncology, Ankara Yıldırım Beyazıt University, Ankara City Hospital, Ankara, Turkey [38]Janssen Research & Development, Raritan, NJ, USA [39]Janssen Research & Development, San Diego, CA, USA [40]Janssen Research & Development, Spring House, PA, USA [41]Janssen Research & Development, Leiden, The Netherlands [42]European Institute of Oncology IRCCS, Milano, Italy

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Phase 3 studies of intravenous amivantamab demonstrated efficacy across EGFR-mutated advanced non-small cell lung cancer (NSCLC). A subcutaneous formulation could improve tolerability and reduce administration time while maintaining efficacy.Patients with EGFR-mutated advanced NSCLC who progressed following osimertinib and platinum-based chemotherapy were randomized 1:1 to receive subcutaneous or intravenous amivantamab, both combined with lazertinib. Co-primary pharmacokinetic noninferiority endpoints were trough concentrations (Ctrough; on cycle-2-day-1 or cycle-4-day-1) and cycle-2 area under the curve (AUCD1-D15). Key secondary endpoints were objective response rate (ORR) and progression-free survival (PFS). Overall survival (OS) was a predefined exploratory endpoint.Overall, 418 patients underwent randomization (subcutaneous group, n=206; intravenous group, n=212). Geometric mean ratios of Ctrough for subcutaneous to intravenous amivantamab were 1.15 (90% CI, 1.04-1.26) at cycle-2-day-1 and 1.42 (90% CI, 1.27-1.61) at cycle-4-day-1; the cycle-2 AUCD1-D15 was 1.03 (90% CI, 0.98-1.09). ORR was 30% in the subcutaneous and 33% in the intravenous group; median PFS was 6.1 and 4.3 months, respectively. OS was significantly longer in the subcutaneous versus intravenous group (hazard ratio for death, 0.62; 95% CI, 0.42-0.92; nominal P=0.02). Fewer patients in the subcutaneous group experienced infusion-related reactions (13% versus 66%) and venous thromboembolism (9% versus 14%) versus the intravenous group. Median administration time for first infusion was reduced to 4.8 minutes (range, 0-18) for subcutaneous amivantamab from 5 hours (range, 0.2-9.9) for intravenous amivantamab. During cycle-1-day-1, 85% and 52% of patients in the subcutaneous and intravenous groups, respectively, considered treatment convenient; end-of-treatment rates were 85% and 35%, respectively.Subcutaneous amivantamab-lazertinib demonstrated noninferiority to intravenous amivantamab-lazertinib, offering a consistent safety profile with reduced infusion-related reactions, increased convenience, and prolonged survival.

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出版当年[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

最新[2023]版：

大类 | 1 区

医学

小类 | 1 区肿瘤学

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第一作者机构： [1]Princess Margaret Cancer Centre, Toronto, Canada [*1]Princess Margaret Cancer Centre 7-913 700 University Ave, Toronto, ON, Canada

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通讯机构： [1]Princess Margaret Cancer Centre, Toronto, Canada [*1]Princess Margaret Cancer Centre 7-913 700 University Ave, Toronto, ON, Canada

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