Alexander Mariam, Cheng Ying, Lee Se-Hoon, Passaro Antonio, Spira Alexander I, Cho Byoung Chul, Lim Sun Min, Ohe Yuichiro, Nagrial Adnan, Tan Jiunn Liang, Wainsztein Vanina, Ramos Elisa, Campelo Maria Del Rosario Garcia, Akamatsu Hiroaki, Nguyen Danny, Cortot Alexis B, Zer Alona, Erdem Dilek, Sanborn Rachel E, Emde Till-Oliver, Minchom Anna R, Zurawski Bogdan, Ferreira Maria Lurdes, Yang James Chih-Hsin, Marmarelis Melina E, Schuchard Julia, Alves Jefferson, Ghosh Debopriya, Balaburski Gregor, Verheijen Remy B, Ribeiro Liliana, Gamil Mohamed, Bauml Joshua M, Baig Mahadi, Leighl Natasha B
Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.
Jilin Cancer Hospital, Changchun, China.
Eur J Cancer. 2025 Sep 9;227:115624. doi: 10.1016/j.ejca.2025.115624. Epub 2025 Jul 10.
Intravenous anticancer treatments present challenges for patients and healthcare professionals (HCPs), prompting the development of subcutaneous formulations. In the phase 3 PALOMA-3 study, subcutaneous amivantamab demonstrated noninferior pharmacokinetics and response rates versus intravenous amivantamab (both with lazertinib), with substantially faster administration, a 5-fold reduction in infusion-related reactions, reduced venous thromboembolism, and numerically prolonged survival.
Participants with EGFR-mutated NSCLC and progression on osimertinib and chemotherapy were randomized to subcutaneous (n = 206) or intravenous amivantamab (n = 212), plus lazertinib. Resource utilization and participant-reported treatment satisfaction were evaluated at cycle (C) 1 day (D) 1 and C3D1.
Time-in-chair was substantially lower for subcutaneous versus intravenous amivantamab (C1D1: median [range], 23 min or 0.4 h [0-12.0 h] vs 6.5 h [0-24.0 h]; C3D1: 35 min or 0.6 h [0-6.6 h] vs 3.4 h [0.5-9.0 h]), as were HCP time and participant time-in-room. More participants who received subcutaneous versus intravenous amivantamab reported feeling unrestricted (C1D1, 66 % vs 29 %; C3D1, 60 % vs 42 %) or unbothered (C1D1, 69 % vs 30 %; C3D1, 71 % vs 45 %) by administration, and reported gaining time for other activities (C1D1, 36 % vs 7 %; C3D1, 37 % vs 6 %). Few participants who received subcutaneous amivantamab reported moderate-to-very severe injection-site pain (C1D1, 14 %; C3D1, 16 %), swelling (C1D1, 5 %; C3D1, 6 %), or redness (C1D1, 5 %; C3D1, 6 %). Most subcutaneous amivantamab recipients preferred and were more satisfied with its administration versus historical experience with intravenous therapies and would recommend it.
In PALOMA-3, subcutaneous amivantamab, which simplifies and shortens administration, reduces resource utilization, and enhances treatment experience, was a preferred option for patients who received amivantamab-lazertinib.
静脉注射抗癌治疗给患者和医护人员带来了挑战,促使皮下制剂的研发。在3期PALOMA-3研究中,皮下注射阿米万他单抗与静脉注射阿米万他单抗(均联合拉泽替尼)相比,显示出非劣效的药代动力学和缓解率,给药速度明显更快,输液相关反应减少5倍,静脉血栓栓塞减少,生存时间在数值上有所延长。
表皮生长因子受体(EGFR)突变的非小细胞肺癌(NSCLC)患者,在接受奥希替尼和化疗后病情进展,被随机分为皮下注射组(n = 206)或静脉注射阿米万他单抗组(n = 212),并联合拉泽替尼。在第1周期第1天(C1D1)和第3周期第1天(C3D1)评估资源利用情况和患者报告的治疗满意度。
皮下注射阿米万他单抗的患者坐在椅子上的时间明显短于静脉注射组(C1D1:中位数[范围],23分钟或0.4小时[0 - 12.0小时]对6.5小时[0 - 24.0小时];C3D1:35分钟或0.6小时[0 - 6.6小时]对3.4小时[0.5 - 9.0小时]),医护人员操作时间和患者在房间内的时间也是如此。与静脉注射阿米万他单抗相比,更多接受皮下注射的患者表示在给药过程中感觉不受限制(C1D1,66%对29%;C3D1,60%对42%)或未受困扰(C1D1,69%对30%;C3D1,71%对45%),并表示有时间进行其他活动(C1D1,36%对7%;C3D1,37%对6%)。接受皮下注射阿米万他单抗的患者中,很少有人报告有中度至非常严重的注射部位疼痛(C1D1,14%;C3D1,16%)、肿胀(C1D1,5%;C3D1,6%)或发红(C1D1,5%;C3D1,6%)。与静脉治疗的既往经历相比,大多数接受皮下注射阿米万他单抗的患者更喜欢并对其给药更满意,且会推荐它。
在PALOMA-3研究中,皮下注射阿米万他单抗简化并缩短了给药过程,减少了资源利用,提高了治疗体验,是接受阿米万他单抗联合拉泽替尼治疗患者的首选方案。