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Clinical Trial
. 2025 Sep 9:227:115624.
doi: 10.1016/j.ejca.2025.115624. Epub 2025 Jul 10.

Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated non-small cell lung cancer: Patient satisfaction and resource utilization results from the PALOMA-3 study

Mariam Alexander  1 , Ying Cheng  2 , Se-Hoon Lee  3 , Antonio Passaro  4 , Alexander I Spira  5 , Byoung Chul Cho  6 , Sun Min Lim  6 , Yuichiro Ohe  7 , Adnan Nagrial  8 , Jiunn Liang Tan  9 , Vanina Wainsztein  10 , Elisa Ramos  11 , Maria Del Rosario Garcia Campelo  12 , Hiroaki Akamatsu  13 , Danny Nguyen  14 , Alexis B Cortot  15 , Alona Zer  16 , Dilek Erdem  17 , Rachel E Sanborn  18 , Till-Oliver Emde  19 , Anna R Minchom  20 , Bogdan Zurawski  21 , Maria Lurdes Ferreira  22 , James Chih-Hsin Yang  23 , Melina E Marmarelis  24 , Julia Schuchard  25 , Jefferson Alves  26 , Debopriya Ghosh  26 , Gregor Balaburski  27 , Remy B Verheijen  28 , Liliana Ribeiro  29 , Mohamed Gamil  27 , Joshua M Bauml  27 , Mahadi Baig  26 , Natasha B Leighl  30
Affiliations
Free article
Clinical Trial

Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated non-small cell lung cancer: Patient satisfaction and resource utilization results from the PALOMA-3 study

Mariam Alexander et al. Eur J Cancer. .
Free article

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: EGFR-mutated NSCLC; Patient satisfaction; Resource utilization; Subcutaneous amivantamab.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships that may be considered as potential competing interests: Mariam Alexander: consulting or advisory role for AbbVie, Amgen, BioAtla, Catalym. Ying Cheng: Nothing to disclose. Se-Hoon Lee: honoraria from AstraZeneca/MedImmune, Roche, Merck, Eli Lilly, Amgen; consulting or advisory role for AstraZeneca, Roche, Merck, Pfizer, Eli Lilly; research funding from Merck. Antonio Passaro: consulting or advisory role for Roche/Genentech, Bristol Myers Squibb, AstraZeneca, MSD, Pfizer, Boehringer Ingelheim, Johnson & Johnson, Novartis, Daiichi Sankyo Europe GmbH, Bayer; speakers bureau member for AstraZeneca, Johnson & Johnson, Boehringer Ingelheim, Daiichi Sankyo Europe GmbH, MSD. Alexander I. Spira: consulting or advisory role for Array BioPharma, Incyte, Amgen, Novartis, Mirati Therapeutics, Gritstone bio, Jazz Pharmaceuticals, Merck, Bristol Myers Squibb, Takeda, Johnson & Johnson, Mersana, Blueprint Medicines, Daiichi Sankyo, AstraZeneca, Regeneron, Eli Lilly, Black Diamond Therapeutics, Sanofi; consulting fees to institution from AstraZeneca/MedImmune; leadership role for NEXT Oncology; stock and ownership interests in Eli Lilly; honoraria from CytomX Therapeutics, AstraZeneca/MedImmune, Merck, Takeda, Amgen, Johnson & Johnson, Novartis, Bristol Myers Squibb, Bayer; research funding of institution from Roche, AstraZeneca, Boehringer Ingelheim, Astellas, MedImmune, Novartis, Incyte, AbbVie, Ignyta, Takeda, MacroGenics, CytomX Therapeutics, Astex Pharmaceuticals, Bristol Myers Squibb, Loxo Oncology, Arch Therapeutics, Gritstone bio, Plexxikon, Amgen, Daiichi Sankyo, ADC Therapeutics, Johnson & Johnson, Mirati Therapeutics, Rubius Therapeutics, Synthekine, Mersana, Blueprint Medicines, Regeneron, Alkermes, Revolution Medicines, Medikine, Black Diamond Therapeutics, BluPrint Oncology, NALO Therapeutics, Scorpion Therapeutics, Arrivent Biopharma. Byoung Chul Cho: consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Roche, Bristol Myers Squibb, Pfizer, Yuhan Corporation, Johnson & Johnson, Takeda, MSD, Ono Pharmaceutical, Eli Lilly, MedPacto, Blueprint Medicines, Cyrus Therapeutics, Guardant Health, Novartis, CJ Bioscience, Abion, BeiGene, CureLogen, Onegene Biotechnology, GI Cell, IMNEWRUN Biosciences, RandBio, Hanmi, Kanaph Therapeutics, BridgeBio, Oscotec; leadership roles for Interpark Bio, J INTS BIO; patents, royalties, or other intellectual property for Champions Oncology, Crown Bioscience, Imagen Bioscience; other relationships with DAAN Biotherapeutics; stock ownership or other ownership interests with Theravance, Gencurix, BridgeBio, Kanaph Therapeutics, Cyrus Therapeutics, Interpark Bio, J INTS BIO; research funding from Novartis, Bayer, AstraZeneca, MOGAM Institute for Biomedical Research, Dong-A ST, Champions Oncology, Johnson & Johnson, Yuhan Corporation, Ono Pharmaceutical, Dizal Pharma, MSD, AbbVie, GI Innovation, Eli Lilly, Blueprint Medicines, Interpark Bio, LG Chem, Oscotec, GI Cell, Abion, Boehringer Ingelheim, CJ Bioscience, Cyrus Therapeutics, Genexine, Nuvalent, Oncternal Therapeutics, Regeneron, BridgeBio, ImmuneOncia, Illumina, Kanaph Therapeutics, Therapex, J INTS BIO, Hanmi, CHA Bundang Medical Center. Sun Min Lim: consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Takeda, J INTS BIO, Bristol Myers Squibb, MSD, Yuhan Corporation, Therapex; research funding of institution from AstraZeneca, Boehringer Ingelheim, GSK, Roche, BridgeBio, Oscotec, Daiichi Sankyo, Gilead, J INTS BIO, Therapex; research funding from Yuhan Corporation, Johnson & Johnson. Yuichiro Ohe: grants/contracts with AstraZeneca, Chugai, Eli Lilly, Ono Pharmaceutical, Bristol Myers Squibb, Kyorin, Dainippon Sumitomo, Pfizer, Taiho Pharma, Novartis, Takeda, Kissei, Daiichi Sankyo, Johnson & Johnson. Adnan Nagrial: consulting or advisory role for MSD, Gilead, Bristol Myers Squibb, Johnson & Johnson, AstraZeneca, Roche. Jiunn Liang Tan: payment or honoraria from MSD, Boehringer Ingelheim, Pfizer, AstraZeneca, Roche, Novartis; travel, accommodations, and expenses from MSD, Pfizer. Vanina Wainsztein: payment or honoraria from Bristol Myers Squibb; payment for expert testimony from Amgen; travel, accommodations, and expenses from AstraZeneca. Elisa Ramos: Nothing to disclose. Maria del Rosario Garcia Campelo: payment or honoraria from Pfizer, Novartis, Roche, Eli Lilly, AstraZeneca, Takeda, MSD; consulting or advisory role for Pfizer, Novartis, Roche, Eli Lilly, AstraZeneca, Takeda, MSD; speakers bureau for Pfizer, Novartis, Roche, Eli Lilly, AstraZeneca, Takeda, MSD. Hiroaki Akamatsu: consulting or advisory role for Amgen, Johnson & Johnson, Sandoz; honoraria from AstraZeneca, Daiichi Sankyo, Eli Lilly, Pfizer, MSD, Bristol Myers Squibb Japan, Taiho Pharma, Chugai, Boehringer Ingelheim, Ono Pharmaceutical, Amgen, Merck, Nippon Kayaku, Novartis, Takeda; research funding of institution from Amgen, Chugai, MSD. Danny Nguyen: payment or honoraria from Johnson & Johnson; leadership or fiduciary role for Gryt Health; consulting or advisory role for Black Diamond Therapeutics. Alexis B. Cortot: grants/contracts from Exeliom; consulting or advisory role for Novartis, AbbVie, Roche, Exeliom, Pfizer, Johnson & Johnson, Amgen, Takeda, AstraZeneca, MSD; payment or honoraria from Pfizer, Amgen, Takeda, Novartis, Roche, AstraZeneca, MSD, Johnson & Johnson, Bristol Myers Squibb; participation on a data safety monitoring/advisory board for InhaTarget, Merck. Alona Zer: consulting or advisory role for MSD, Takeda, AstraZeneca, AbbVie; payment or honoraria from MSD, Takeda, AstraZeneca; travel, accommodations, and expenses from Roche; participation on a data safety monitoring/advisory board for Beyond Cancer; stock or stock options in Nixio. Dilek Erdem: Nothing to disclose. Rachel E. Sanborn: advisory board member for AbbVie, Amgen, AstraZeneca, Daiichi Sankyo, Eli Lilly, GE HealthCare, Gilead, IDEOlogy Health, Inhibrx, Johnson & Johnson, Sanofi-Aventis, Regeneron, GSK, G1 Therapeutics; invited speaker for Illumina, OncLive, PRIME Education; steering committee member at AstraZeneca, BeiGene, GSK, Johnson & Johnson; research funding from Merck, AstraZeneca; research funding of institution from Bristol Myers Squibb, Jounce Therapeutics. Till-Oliver Emde: grants/contracts from Janssen-Cilag, a Johnson & Johnson company, Roche, Eli Lilly, Daiichi Sankyo, GBG Forschungs, WSG Laboratories, iOMEDICO, Bristol Myers Squibb, Sanofi; honoraria from AbbVie; travel, accommodations, and expenses from Janssen-Cilag, a Johnson & Johnson company, BeiGene; participation on a data safety monitoring/advisory board for AstraZeneca, BeiGene, Bristol Myers Squibb GmbH & Co. KGaA, Daiichi Sankyo Deutschland GmbH, Pfizer Pharma GmbH, AbbVie. Anna R. Minchom: advisory board member for Johnson & Johnson, Merck, Takeda, MSD, Genmab, Pfizer, AstraZeneca, Immutep; honoraria from Chugai, Faron Pharmaceuticals, Merck, GSK, Seagen, Takeda, Johnson & Johnson; research funding of institution from Merck, MSD, Astex Pharmaceuticals; travel, accommodations, and expenses from Amgen, Johnson & Johnson. Bogdan Zurawski: honoraria from Roche, Astellas; employment with MSD, Johnson & Johnson, Bristol Myers Squibb, Roche, Novartis, GSK, Merck Serono. Maria Lurdes Ferreira: Nothing to disclose. James Chih-Hsin Yang: honoraria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche, Takeda; consulting or advisory role for AbbVie, Amgen, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb/Celgene, Clovis Oncology, Daiichi Sankyo, G1 Therapeutics, Hansoh Pharma, Incyte, Eli Lilly, Merck Serono, MSD, Novartis, Ono Pharmaceutical, Pfizer, Takeda, Yuhan Corporation; consulting fees to institution from Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, GSK, Johnson & Johnson, Merck Serono, MSD, Novartis, Takeda; travel, accommodations, and expenses from Pfizer. Melina E. Marmarelis: stock and other ownership interests in Johnson & Johnson, Merck; honoraria from AstraZeneca, Blueprint Medicines, Johnson & Johnson, Novocure, Takeda, Targeted Oncology, Thermo Fisher Scientific; honoraria for institution from Health Advances; consulting or advisory role for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb/Celgene, Ikena Oncology, Regeneron, Daiichi Sankyo; research funding of institution from AstraZeneca, Eli Lilly, Merck, Genentech, Trizell; travel, accommodations, and expenses from Boehringer Ingelheim, Novocure. Julia Schuchard: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Jefferson Alves: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Debopriya Ghosh: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Gregor Balaburski: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Remy B. Verheijen: employee of Janssen Research and Development, a Johnson & Johnson company, and may hold stock in Johnson & Johnson. Liliana Ribeiro: employee of Janssen-Cilag Farmacêutica, a Johnson & Johnson company and may hold stock in Johnson & Johnson. Mohamed Gamil: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Joshua M. Bauml: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Mahadi Baig: employee of Johnson & Johnson and may hold stock in Johnson & Johnson. Natasha B. Leighl: grants or contracts (institution) from AstraZeneca, Eli Lilly, Johnson & Johnson, MSD, Novartis, Pfizer, Guardant Health, NeoGenomics; travel, accommodations, expenses (independent CME lectures) from AstraZeneca, Eisai, Guardant Health, Johnson & Johnson, MSD, Roche, Sanofi; participation on data safety monitoring board (uncompensated) for Daiichi Sankyo.

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