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Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study

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收录情况： ◇ SCIE

作者：
Leighl, Natasha B.[1] * ; Akamatsu, Hiroaki[2] ; Lim, Sun Min[3] ; Cheng, Ying[4] ; Minchom, Anna R.[5,6] ; Marmarelis, Melina E.[7] ; Sanborn, Rachel E.[8] ; Chih-Hsin Yang, James[9] ; Liu, Baogang[10] ; John, Thomas[11] ; Massuti, Bartomeu[12] ; Spira, Alexander I.[13] ; Lee, Se-Hoon[14] ; Wang, Jialei[15] ; Li, Juan[16] ; Liu, Caigang[17] ; Novello, Silvia[18] ; Kondo, Masashi[19] ; Tamiya, Motohiro[20] ; Korbenfeld, Ernesto[21] ; Moskovitz, Mor[22] ; Han, Ji-Youn[23] ; Alexander, Mariam[24] ; Joshi, Rohit[25] ; Felip, Enriqueta[26] ; Voon, Pei Jye[27] ; Danchaivijitr, Pongwut[28] ; Hsu, Ping-Chih[29] ; Silva Melo Cruz, Felipe Jose[30] ; Wehler, Thomas[31,32] ; Greillier, Laurent[33] ; Teixeira, Encarnacao[34] ; Nguyen, Danny[35] ; Sabari, Joshua K.[36] ; Qin, Angel[37] ; Kowalski, Dariusz[38] ; Sendur, Mehmet Ali Nahit[39] ; Xie, John[40] ; Ghosh, Debopriya[40] ; Alhadab, Ali[41] ; Haddish-Berhane, Nahor[42] ; Clemens, Pamela L.[42] ; Lorenzini, Patricia[42] ; Verheijen, Remy B.[43] ; Gamil, Mohamed[42] ; Bauml, Joshua M.[42] ; Baig, Mahadi[40] ; Passaro, Antonio[44] ;
机构： [1]Princess Margaret Canc Ctr, Toronto, ON, Canada [2]Wakayama Med Univ, Internal Med 3, Wakayama, Japan [3]Yonsei Univ, Coll Med, Dept Internal Med, Div Med Oncol, Seoul, South Korea [4]Jilin Canc Hosp, Changchun, Peoples R China [5]Royal Marsden Hosp & Inst Canc Res, Drug Dev Unit, Sutton, England [6]Inst Canc Res, Sutton, England [7]Univ Penn, Perelman Sch Med, Dept Med, Div Hematol Oncol, Philadelphia, PA USA [8]Providence Canc Inst, Earle A Chiles Res Inst, Portland, OR 97213 USA [9]Natl Taiwan Univ, Canc Ctr, Dept Med Oncol, Taipei, Taiwan [10]Harbin Med Univ, Canc Hosp, Harbin, Peoples R China [11]Univ Melbourne, Peter MacCallum Canc Ctr, Melbourne, Vic, Australia [12]Alicante Univ, Dr Balmis Hosp, ISABIAL, Alicante, Spain [13]Virginia Canc Specialists, Fairfax, VA USA [14]Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Seoul, South Korea [15]Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China [16]Sichuan Canc Hosp, Chengdu, Sichuan, Peoples R China [17]USTC, Hefei, Peoples R China [18]Univ Turin, S Luigi Gonzaga Hosp, Dept Oncol, Orbassano, TO, Italy [19]Fujita Hlth Univ, Sch Med, Dept Resp Med, Toyoake, Japan [20]Osaka Int Canc Inst, Dept Thorac Oncol, Osaka, Japan [21]British Hosp Buenos Aires, Cent British Hosp, Buenos Aires, Argentina [22]Rabin Med Ctr, Davidoff Canc Ctr, Petah Tiqwa, Israel [23]Natl Canc Ctr, Goyang, South Korea [24]Med Univ South Carolina, Charleston, SC USA [25]Canc Res SA, Adelaide, SA, Australia [26]Univ Autonoma Barcelona, Vall dHebron Barcelona Hosp Campus, Vall dHebron Inst Oncol VIHO, Med Oncol Dept, Barcelona, Spain [27]Sarawak Gen Hosp, Dept Radiotherapy & Oncol, Kuching, Malaysia [28]Mahidol Univ Bangkok NoiCampus, Siriraj Hosp, Fac Med, Bangkok, Thailand [29]Chang Gung Univ, Chang Gung Mem Hosp, Coll Med, Dept Thorac Med, Taoyuan, Taiwan [30]IFG Brazil, Nucl Ensino & Pequisa, Goiania, Go, Brazil [31]Rheumatol, Giessen, Germany [32]Univ Hosp Giessen & Marburg, Marburg, Germany [33]Aix Marseille Univ, Hop Nord, APHM, Multidisciplinary Oncol & Therapeut Innovat Dept,N, Marseille, France [34]Hosp CUF Descobertas, Med Oncol, Lisbon, Portugal [35]City Hope Natl Med Ctr, Duarte, CA USA [36]NYU Langone Hlth, Perlmutter Canc Ctr, New York, NY USA [37]Univ Michigan, Rogel Canc Ctr, Ann Arbor, MI USA [38]Maria Sklodowska Curie Natl Res Inst Oncol, Dept Lung Canc & Thorac Tumors, Warsaw, Poland [39]Ankara Yildirim Beyazit Univ, Ankara City Hosp, Dept Med Oncol, Ankara, Turkiye [40]Janssen Res & Dev, Raritan, NJ USA [41]Janssen Res & Dev, San Diego, CA USA [42]Janssen Res & Dev, Spring House, PA USA [43]Janssen Res & Dev, Leiden, Netherlands [44]European Inst Oncol, Milan, Italy
出处：
DOI： 10.1200/JCO.24.01001
ISSN：

摘要：
PURPOSEPhase III studies of intravenous amivantamab demonstrated efficacy across epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC). A subcutaneous formulation could improve tolerability and reduce administration time while maintaining efficacy.PATIENTS AND METHODSPatients with EGFR-mutated advanced NSCLC who progressed after osimertinib and platinum-based chemotherapy were randomly assigned 1:1 to receive subcutaneous or intravenous amivantamab, both combined with lazertinib. Coprimary pharmacokinetic noninferiority end points 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 end points were objective response rate (ORR) and progression-free survival (PFS). Overall survival (OS) was a predefined exploratory end point.RESULTSOverall, 418 patients underwent random assignment (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 to 1.26) at cycle-2-day-1 and 1.42 (90% CI, 1.27 to 1.61) at cycle-4-day-1; the cycle-2 AUCD1-D15 was 1.03 (90% CI, 0.98 to 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 to 0.92; nominal P = .02). Fewer patients in the subcutaneous group experienced infusion-related reactions (IRRs; 13% v 66%) and venous thromboembolism (9% v 14%) versus the intravenous group. Median administration time for the first infusion was reduced to 4.8 minutes (range, 0-18) for subcutaneous amivantamab and to 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; the end-of-treatment rates were 85% and 35%, respectively.CONCLUSIONSubcutaneous amivantamab-lazertinib demonstrated noninferiority to intravenous amivantamab-lazertinib, offering a consistent safety profile with reduced IRRs, increased convenience, and prolonged survival. PALOMA-3 shows noninferior PK, efficacy, better safety, and faster administration subcutaneous versus IV amivantamab.

基金：
Janssen Global Services, LLC
语种：
外文
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2024]版：
无
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Princess Margaret Canc Ctr, Toronto, ON, Canada
通讯作者：
推荐引用方式(GB/T 7714)：
Leighl Natasha B.,Akamatsu Hiroaki,Lim Sun Min,et al.Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study[J].JOURNAL OF CLINICAL ONCOLOGY.2024,42(30):doi:10.1200/JCO.24.01001.
APA：
Leighl, Natasha B.,Akamatsu, Hiroaki,Lim, Sun Min,Cheng, Ying,Minchom, Anna R....&Passaro, Antonio.(2024).Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study.JOURNAL OF CLINICAL ONCOLOGY,42,(30)
MLA：
Leighl, Natasha B.,et al."Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study".JOURNAL OF CLINICAL ONCOLOGY 42..30(2024)

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