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. 2025 Apr;21(9):1033-1044.
doi: 10.1080/14796694.2025.2474789. Epub 2025 Mar 24.

Sotorasib versus docetaxel for previously treated KRAS G12C-mutated non-small-cell lung cancer: a plain language summary

Adrianus Johannes de Langen  1 , Melissa L Johnson  2 , Julien Mazieres  3 , Anne-Marie C Dingemans  4 , Giannis Mountzios  5 , Miklos Pless  6 , Jürgen Wolf  7 , Martin Schuler  8 , Hervé Lena  9 , Ferdinandos Skoulidis  10 , Yasuto Yoneshima  11 , Sang-We Kim  12 , Helena Linardou  13 , Silvia Novello  14 , Anthonie J van der Wekken  15 , Yuanbin Chen  16 , Solange Peters  17 , Enriqueta Felip  18 , Benjamin J Solomon  19 , Suresh S Ramalingam  20 , Christophe Dooms  21 , Colin R Lindsay  22   23 , Carlos Gil Ferreira  24 , Normand Blais  25 , Cynthia C Obiozor  26 , Yang Wang  26 , Bhakti Mehta  26 , Tracy Varrieur  26 , Gataree Ngarmchamnanrith  26 , Björn Stollenwerk  27 , David Waterhouse  28 , Luis Paz-Ares  29 ; CodeBreaK 200 Investigators
Affiliations

Sotorasib versus docetaxel for previously treated KRAS G12C-mutated non-small-cell lung cancer: a plain language summary

Adrianus Johannes de Langen et al. Future Oncol. 2025 Apr.

Erratum in

  • Future Oncol.
No abstract available

Plain language summary

What is this summary about?The CodeBreaK 200 clinical study included patients with a type of lung cancer called non–small-cell lung cancer that has spread outside the lung (advanced) and had a particular change (mutation) in the KRAS gene. This mutation leads to the mutated protein called KRAS G12C and can lead to lung cancer. The CodeBreaK 200 clinical study looked at whether treatment with sotorasib works better and has fewer side effects than docetaxel. Sotorasib has accelerated approval or full approval for use in over 50 countries for patients with previouslytreated advanced KRAS G12C–mutated non–small-cell lung cancer.What did investigators find?There were 171 adults in the sotorasib group and 174 in the docetaxel group. The median time that patients in the sotorasib group whose disease was no worse or who did not die was 5.6 months. For patients in the docetaxel group, this was 4.5 months. After 1 year, 25% of patients in the sotorasib group had disease that was no worse or did not die. This happened in 100% of patients in the docetaxel group. In total, 48 out of 171 patients (28%) in the sotorasib group had a positive effect to treatment, and their tumors shrunk in size by at least 30% or disappeared. This happened in 23 out of 174 patients (13%) in the docetaxel group. Additionally, 141 out of 171 patients (82%) in the sotorasib group had tumors that either remained stable or shrunk in size. This happened in 105 out of 174 patients (60%) in the docetaxel group. Patients in both the sotorasib and docetaxel groups had a similar median survival (10.6 months in the sotorasib group compared with 11.3 months in the docetaxel group). Almost all patients treated with sotorasib or docetaxel had side effects. They were severe in 56 out of 169 patients (33%) receiving sotorasib and 61 out of 151 patients (40%) receiving docetaxel.What is the key takeaway?Sotorasib is an effective treatment for previously–treated patients with advanced KRAS G12C–mutated non–small-cell lung cancer.[Box: see text].

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Conflict of interest statement

Dr de Langen reports financial interests, institutional, research grant from BMS, MSD, Boehringer, AstraZeneca; non-financial interests, other from Merck Serono, Roche. Dr Johnson reports financial interests, institutional, research grant from AbbVie, Acerta, Adaptimmune, Amgen, Apexigen, Arcus Biosciences, Array BioPharma, Artios Pharma, AstraZeneca, Atreca, BeiGene, BerGenBio, BioAtla, Boehringer Ingelheim, Calithera Biosciences, Corvus Pharmaceuticals, Curis, CytomX, Daiichi Sankyo, Dracen Pharmaceuticals, Dynavax, Lilly, EMD Serono, Erasca, Exelixis, Fate Therapeutics, Genentech/Roche, Genmab, Genocea Biosciences, GlaxoSmithKline, Gritstone Oncology, Guardant Health, Harpoon, Helsinn Healthcare, Hengrui Therapeutics, Hutchison MediPharma, IDEAYA Biosciences, IGM Biosciences, Immunocore, Incyte, Janssen, Kadmon Pharmaceuticals, Loxo Oncology, Lycera, Memorial Sloan-Kettering, Merck, Merus, NeoImmune Tech, Neovia Oncology, Novartis, Numab Therapeutics, Nuvalent, OncoMed Pharmaceuticals, Pfizer, PMV Pharmaceuticals, Regeneron Pharmaceuticals, Relay Therapeutics, Revolution Medicines, Ribon Therapeutics, Rubius Therapeutics, Sanofi, Seven and Eight Biopharmaceuticals/Birdie Biopharmaceuticals, Shattuck Labs, Silicon Therapeutics, Stem CentRx, Syndax Pharmaceuticals, Takeda Pharmaceuticals, Tarveda Therapeutics, TCR2 Therapeutics, Tempest Therapeutics, Tizona Therapeutics, Tmunity Therapeutics, Turning Point Therapeutics, University of Michigan, Vyriad, WindMIL, Y-mAbs Therapeutics, Black Diamond, Carisma Therapeutics, Elicio Therapeutics, EQRx, Immunitas Therapeutics, Kartos Therapeutics, Mirati Therapeutics, Palleon Pharmaceuticals, Rain Therapeutics; financial interests, institutional, consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Axelia Oncology, Black Diamond, Calithera Biosciences, Checkpoint Therapeutics, CytomX Therapeutics, Daiichi Sankyo, EcoR1, Editas Medicine, Eisai, Genentech/ Roche, Genmab, Genocea Biosciences, GlaxoSmithKline, Gritstone Oncology, IDEAYA Biosciences, iTeos Therapeutics, Janssen, Lilly, Merck, Mirati Therapeutics, Molecular Axiom, Novartis, Oncorus, Regeneron Pharmaceuticals, Ribon Therapeutics, Sanofi-Aventis, Turning Point Therapeutics, VBL Therapeutics, Takeda Pharmaceuticals, Arrivant, Pyramid Biosciences, Revolution Medicines, Seagen. Dr Mazieres reports financial interests, personal fees from Amgen, AstraZeneca, Roche, Pierre Fabre, Pfizer; financial interests, institutional, research grant from AstraZeneca, Roche, Pierre Fabre; advisory board for Merck, Roche, AstraZeneca, MSD, BMS, Pfizer, Hengrui Therapeutics, Daiichi, Boehringer, Pierre Fabre, Amgen. Dr Dingemans reports other, institutional, advisory board for Amgen, Bayer, Boehringer Ingelheim, Roche, Sanofi; other, institutional, invited speaker for AstraZeneca, Janssen, Eli Lilly, Pfizer, Takeda; financial interests, institutional, research grant from Amgen; financial interests, institutional, principal investigator, local PI for Amgen, Daiichi, JNJ, Eli Lilly, Mirati Therapeutics; financial interests, institutional, principal investigator, coordinating PI for Roche; financial interests, institutional, other, steering committee member for Roche. Dr Mountzios reports financial interests, personal, other, consulting fees from Roche Hellas, Novartis Greece, BMS Greece, MSD Greece, AstraZeneca Greece, Takeda Hellas, Janssen Greece, GSK Greece, Amgen Hellas, Sanofi Greece, Boehringer Greece; financial interests, personal, other, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Roche Hellas, Novartis Greece, BMS Greece, MSD Greece, AstraZeneca Greece, Takeda Hellas, Pierre Fabre Greece, Janssen Greece, GSK Greece, Amgen Hellas, Sanofi Greece, Boehringer Greece; financial interests, personal, other, payment for expert testimony from Roche Hellas, Novartis Greece, BMS Greece, MSD Greece, AstraZeneca Greece, Takeda Hellas, Pierre Fabre Greece, Janssen Greece, GSK Greece, Amgen Hellas, Sanofi Greece, Boehringer Greece; financial interests, personal, other, support for attending meetings and/or travel from Roche Hellas, Novartis Greece, BMS Greece, MSD Greece, AstraZeneca Greece, Takeda Hellas, Pierre Fabre Greece, Janssen Greece, GSK Greece, Amgen Hellas, Sanofi Greece, Boehringer Greece; financial interests, personal, other, participation on a data safety monitoring board or advisory board for Roche Hellas, Novartis Greece, BMS Greece, MSD Greece, AstraZeneca Greece, Takeda Hellas, Janssen Greece, GSK Greece, Amgen Hellas, Sanofi Greece, Boehringer Greece; financial interests, personal, other, leadership or fiduciary role in other board, society, committee or advocacy group, unpaid for European Society for Medical Oncology working groups (Educational Publication Working Group, Adolescents and Young Adults working group); financial interests, institutional, principal investigator for Roche Hellas, Novartis Greece, BMS Greece, MSD Greece, AstraZeneca Greece, Gilead Greece, GSK Greece, Amgen Hellas, Sanofi Greece. 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Dr Lena reports financial interests, other, personal fees from Daiichi Sankyo, AstraZeneca, Pfizer, Novartis, Amgen, MSD, Roche, BMS, Eli Lilly, Boehringer Ingelheim. 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Dr Novello reports financial interests, personal, advisor/speaker bureau for AstraZeneca, BI, MSD, Roche, Sanofi, Pfizer, Takeda, Thermo Fisher, Novartis; financial interests, personal, speaker bureau for BeiGene. Dr van der Wekken reports financial interests, institutional, research grant from AstraZeneca, Boehringer-Ingelheim, Pfizer, Roche, Takeda; financial interests, fees to institution from AstraZeneca, Boehringer-Ingelheim, Pfizer, Roche, Takeda, Janssen Cilag, Lilly, Amgen, Merck. Dr Chen reports other, personal, speaker faculty for Amgen, AstraZeneca, Bristol Myers Squibb, Guardant Health, Jazz Pharmaceuticals, Pfizer, Takeda; other, personal, advisory board for AstraZeneca, Bristol Myers Squibb, Mirati Therapeutics; financial interests, institutional, principal investigator, local PI for Amgen, AstraZeneca, Bristol Myers Squibb, EMD/Serono, Helsinn, Ipsen, Merck. Dr Peters reports financial interests, institutional, support for study conduct and medical writing from AstraZeneca; financial interests, institutional, principal investigator, coordinating PI for Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, GlaxoSmithKline, Merck Sharp and Dohme, Roche/Genentech. Financial interests, institutional, consulting fees from AbbVie, AiCME, Amgen, Arcus, AstraZeneca, Bayer, BeiGene, Biocartis, BioInvent, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, ecancer, Eli Lilly, Elsevier, F-Star, Fishawack, Foundation Medicine, Genzyme, Gilead, GlaxoSmithKline, Illumina, Imedex, IQVIA, Incyte, Ipsen, iTeos, Janssen, Medscape, Medtoday, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Novocure, OncologyEducation, Pharma Mar, Phosplatin Therapeutics, PER, PeerView, Pfizer, PRIME, Regeneron, RMEI, Roche/Genentech, RTP, Sanofi, Seattle Genetics, Takeda, Vaccibody; financial interests, institution, other, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AiCME, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, ecancer, Eli Lilly, Foundation Medicine, Illumina, Imedex, Medscape, Merck Sharp and Dohme, Mirati Therapeutics, Novartis, PeerView, PER, Pfizer, Prime, Roche/Genentech, RTP, Sanofi, Takeda; financial interests, institutional, other, support for attending meetings and/or travel from AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, Roche/Genentech, Takeda; financial interests, institutional, other, participation on a data safety monitoring board or advisory board for AbbVie, AiCME, Amgen, Arcus, AstraZeneca, Bayer, BeiGene, Biocartis, BioInvent, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, ecancer, Eli Lilly, Elsevier, F-Star, Fishawack, Foundation Medicine, Genzyme, Gilead, GSK, Illumina, Imedex, IQVIA, Incyte, Ipsen, iTeos, Janssen, Medscape, Medtoday, Merck Sharp and Dohme, Merck Serono, Merrimack, Novartis, Novocure, OncologyEducation, Pharma Mar, Phosplatin Therapeutics, PER, PeerView, Pfizer, PRIME, Regeneron, RMEI, Roche/Genentech, RTP, Sanofi, Seattle Genetics, Takeda, Vaccibody. Dr Felip reports financial interests, institutional, research grant from Merck Healthcare KGaA (grant for oncology innovation), Fundación Merck Salud; financial interests, institutional, consulting fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, GlaxoSmithKline, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Pfizer, Sanofi, Takeda, BerGenBio; financial interests, institutional, payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Janssen, Medical Trends, Medscape, Merck Serono, Merck Sharp & Dohme, PeerVoice, Pfizer, Sanofi, Takeda, Touch Oncology; other financial/non-financial interests, board member for Grífols. 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Dr Paz-Ares reports financial interests, research grant from MSD, AstraZeneca, Pfizer, BMS; financial interests, consulting fees from Lilly, MSD, Roche, PharmaMar, Merck, AstraZeneca, Novartis, Servier, Amgen, Pfizer, Sanofi, Bayer, BMS, Mirati Therapeutics, GSK, Janssen, Takeda, Daiichi Sankyo; financial interests, payment/honoraria for lectures, presentations, speakers bureau from AstraZeneca, Janssen, Merck, Mirati Therapeutics. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing support was provided by Lisa Denny, PhD, of ICON plc (Blue Bell, PA, USA) and Liz Leight, PhD, of Amgen (Thousand Oaks, CA, USA), and was funded by Amgen.

Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

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