Plain Language SummaryWhat was the purpose of the FLAURA2 study?This is a summary of the main results of the FLAURA2 clinical study in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC). The results were published in full in 2023.NSCLC is the most common type of lung cancer, but is often not diagnosed until the cancer has spread beyond the lungs described as 'metastastic' or 'advanced' disease.Epidermal growth factor (EGF) binds to the EGFR (epidermal growth factor receptor) and leads to signaling events that control how cells grow and divide.Healthy cells transform into cancer cells when changes (mutations) occur in the EGFR gene, in NSCLC this is known as EGFR-mutated NSCLC. Osimertinib (TAGRISSO®) is a drug that has already been shown to treat EGFR-mutated NSCLC by blocking the effects of mutated EGFR, and preventing, slowing or stopping the growth of cancer cells. Osimertinib is approved and recommended by international treatment guidelines as initial (first-line) treatment for EGFR-mutated advanced NSCLC, but when osimertinib stops working, chemotherapy is usually recommended as the next treatment. However, many patients with EGFR-mutated NSCLC do not receive another treatment after first-line osimertinib, mainly because their health has become too poor. This means that it is important to make sure the best treatment is given first. The FLAURA2 study assessed whether adding chemotherapy to osimertinib as first-line treatment for patients with EGFR-mutated advanced NSCLC could extend the time before cancer cells grew/spread,or prolong the time before patients died.What were the results?In the FLAURA2 study, patients with EGFR-mutated advanced NSCLC received first-line treatment consisting of either chemotherapy (a platinum drug plus pemetrexed) added to osimertinib, or osimertinib alone. Osimertinib plus chemotherapy extended the time from when patients were assigned a treatment until the cancer grew/spread, or until death, compared with osimertinib alone.What do the results of the study mean?The results show that addition of chemotherapy to first-line osimertinib could be beneficial for patients with EGFR-mutated advanced NSCLC. Side effects of the combination were similar to those of either chemotherapy or osimertinib alone, and the combination was considered tolerable. The findings led to osimertinib plus chemotherapy being approved in a number of countries, including China, Japan, the USA, and the European Union, as a new first-line treatment option. The FLAURA2 study is ongoing, and more results are expected to be released in the future.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-text AcknowledgmentsAstraZeneca would like to thank all of the patients who participated in this study, their families and all of the study center staff members who contributed.The authors would also like to thank Nicoline Ehrhardt, Laura Floyd, and Dave Nitsche for reviewing this article and providing valuable contributions to the development of this plain language summary publication.Disclosure statementDavid Planchard reports consulting fees from AbbVie, Arrivent, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Daiichi-Sankyo, F. Hoffmann-La Roche, Janssen, Merck, Mirati Therapeutics, Novartis, Pfizer, Pierre Fabre Pharmaceuticals Inc, Samsung, Sanofi-Aventis U.S. LLC, Seagen Inc, Taiho Pharmaceutical,and Takeda. Pasi A. Jänne reports consulting fees from AbbVie, Accutar Biotech, Allorion Therapeutics, AstraZeneca, Bayer, Biocartis, Boehringer Ingelheim,Chugai Pharma, Daiichi-Sankyo, Duality Biologics, Eli Lilly, Eisai, F. Hoffmann-La Roche, Frontier Medicines, Hongyun Biotechnology, Merus, Mirati Therapeutics,Novartis, Nuvalent, Pfizer, Sanofi Pasteur Biologics LLC, SFJ Pharmaceuticals, Silicon Therapeutics, Syndax, Takeda, Transcenta, and Voronoi; stock with Gatekeeper Pharmaceuticals; patent/inventor with Laboratory corporation. Ying Cheng has nothing to disclose. James Chih-Hsin Yang reports advisory board fees from Abbvie,Amgen, AnHeart Therapeutics, ArriVent, AstraZeneca, Bayer, Black Diamond Therapeutics Inc, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, F. Hoffmann-La Roche, Gilead, GlaxoSmithKline, Janssen, Merck KGaA, MSD, Novartis, Pfizer, Regeneron Pharmaceuticals, Takeda, and Yuhan Pharmaceuticals; coordinating PI for AstraZeneca, Dizal Pharmaceuticals, and MSD; travel funding from AstraZeneca, Dizal Pharmaceuticals, and Takeda; local PI from Amgen, ArriVent, AstraZeneca,Bayer, Boehringer Ingelheim, Daiichi-Sankyo, Dizal Pharmaceuticals, Eli Lilly, F. Hoffmann-La Roche, Gilead, Ipsen, Janssen, Merck KGaA, MSD, Novartis, Numab Therapeutics AG, Takeda, and Yuhan Pharmaceuticals; member of ASCO, ESMO, IASLC; research grants from AstraZeneca, and F. Hoffmann-La Roche; steering committee member for Amgen, ArriVent, AstraZeneca, Bayer, Black Diamond Therapeutics Inc, Daiichi-Sankyo, Dizal Pharmaceuticals, Eli Lilly, Janssen, Merck KGaA,MSD, Numab Therapeutics AG, Takeda, and Yuhan Pharmaceuticals. Noriko Yanagitani reports lecture fees from AstraZeneca, Bristol Myers Squibb, Chugai Pharma,Eli Lilly, Kyowa Hakko Kirin, Novartis, Ono Medical Research Foundation, Pfizer, Taiho Pharmaceutical, and Takeda; consulting fees from Chugai Pharma; advisory board fees from Pfizer. Sang-We Kim has nothing to disclose. Shunichi Sugawara reports grants from AbbVie, Accerise, Amgen, AnHeart, AstraZeneca, A2 Healthcare,Bristol Myers Squibb, Chugai Pharma, Daiichi-Sankyo, EPS, MSD, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Parexel, PPD, Syneos, and Taiho Pharmaceutical; honoraria/lecture/speaker fees from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Chugai Pharma, Eisai, Eli Lilly, Kyowa Kirin, Merck, MSD, Nippon Boehringe Ingelheim, Nippon Kayaku, Novartis, Ono Pharmaceutical, Otsuka, Pfizer, Sysmex, Taiho Pharmaceutical, Takeda, Thermo Fisher Scientific, and Towa Pharmaceutical.Yan Yu has nothing to disclose. Yun Fan has nothing to disclose. Sarayut Lucien Geater reports advisory board fees from Boehringer Ingelheim, and Pfizer; principal investigator for AstraZeneca, Boehringer Ingelheim, F. Hoffman-La Roche, MSD, and Novartis. Konstantin Laktionov has nothing to disclose. Chee Khoon Lee reports grants from Amgen, AstraZeneca, Merck kGaA, and Roche; honoraria/lecture/speaker fees from Amgen, AstraZeneca, Gilead, GlaxoSmithKline, Janssen, Merck, Merck kGaA, Novartis, Roche, and Takeda. Natalia Valdiviezo has nothing to disclose. Samreen Ahmed reports advisory board/consulting fees from AstraZeneca.Jean-Marc Maurel has nothing to disclose. Igor Andrasina has nothing to disclose. Jonathan Goldman reports research funding from AbbVie, Advaxis, Agenus,Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Merck, Pfizer, Puma, RayzeBio, Summit, and Tango; consulting fees from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Genentech, Gilead, Gritstone, Janssen, Jazz, Lilly, Pfizer, Puma, Regeneron, and Summit. Dana Ghiorghiu reports employment and stock with AstraZeneca. Yuri Rukazenkov reports employment and stock with AstraZeneca. Alex Todd reports employment and stock with AstraZeneca. Kunihiko Kobayashi reports speaker fees from AstraZeneca; consulting fees from Daiichi-Sankyo/UCB Japan; research funding from Zeria Pharmaceutical Co; co-inventor on Japanese patent # 7422498.Disclosure forms provided by the authors are available with the full text of the original article at NEJM.org.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 under the direction of the authors was provided by Fiona Neylon, BSc, of Ashfield MedComms, an Inizio company, funded by AstraZeneca in accordance with Good Publications Practice (GPP) guidelines (https://www.ismpp.org/gpp-2022).Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.Ethical disclosureThe trial was conducted in accordance with the provisions of the Declaration of Helsinki, Good Clinical Practice guidelines (as defined by the International Conference for Harmonisation), applicable regulatory requirements, and the policy of the trial sponsor, AstraZeneca, on bioethics and human biologic samples. All the patients provided written informed consent.FundingThe pharmaceutical company AstraZeneca funded and were responsible for conducting this study.
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