Abstract

Plain Language SummaryWhat is this summary about?This summary describes early (not final) results of a clinical study called CHOICE-01. The study looked at the effect of a medicine called toripalimab when added to standard chemotherapy (chemicals used to stop the growth of or kill cancer cells) for adults with untreated non-small cell lung cancer (NSCLC) without driver mutations (i.e. EGFR/ALK mutations excluded from the study) that was classified as locally advanced or had spread to other parts of the body (metastatic NSCLC). Researchers wanted to see whether toripalimab added to standard chemotherapy was safe and effective for increasing the amount of time adults with untreated advanced NSCLC not suitable for surgery could live without their cancer getting worse (a measurement called 'progression-free survival'), and living longer (a measurement called "overall survival").What are the key takeaways?Results from the CHOICE-01 study showed that adults with advanced inoperable NSCLC treated with toripalimab plus standard chemotherapy had significantly longer progression-free survival than those who received standard chemotherapy alone. Early results for overall survival, a measurement of how long patients lived overall, also demonstrated significantly better results in the group treated with toripalimab. The treatment groups with and without toripalimab had similar rates of side effects (effects of a medicine that are beyond its desired effect that can be harmful), which were tracked to assess safety.What were the main conclusions reported by the researchers?The results of the CHOICE-01 study showed that patients with advanced NSCLC treated with toripalimab plus chemotherapy had longer progression-free survival and overall survival than those who received chemotherapy alone. These results support the addition of toripalimab to chemotherapy for adults with untreated advanced NSCLC without driver mutations.Who is this summary for?This summary is intended to provide information to adults with advanced NSCLC and their family members or caregivers. It may also be helpful for patient advocates and healthcare professionals.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 Author contributionsI certify that each co-author listed on page 1 participated sufficiently in the work to take responsibility for the content, and that all those who qualify are listed. Authorship credit should be based on (a) substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (b) drafting the work or revising it critically for important intellectual content; AND (c) final approval of the version to be published; AND (d) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved; AND (e) all listed authors agreed to the journal it will be submitted to AND (f) all authors were involved in reviewing and agreeing to all versions of the submission during revisions, final version etc. Conditions (a), (b), (c), (d), (e) and (f) must all be met.FundingThe CHOICE-01 study is sponsored by Shanghai Junshi Biosciences and supported by National key research and development project (2019YFC1315700), CAMS Innovation Fund for Medical Sciences (2021-1-I2M-012), the National Natural Sciences Foundation of China (81871889 and 82072586), Beijing Natural Science Foundation (7212084), Aiyou Foundation (KY201701), National Major Science & Technology Major Projects (2017ZX09302009), and Shanghai Science and Technology Committee Technology Grant (17431900700).Declaration of interestsThe following represents disclosure information. All relationships are considered compensated unless otherwise noted. Zhijie Wang, Speakers' Bureau: Roche China, MSD; Lin Wu, Employment: AstraZeneca, Roche, Bristol Myers Squibb, MSD, Pfizer, Lilly, Boehringer Ingelheim, Merck, Innovent Biologics, Hengrui Pharmaceutical; Qiming Wang, Consulting or Advisory Role: Hansoh Pharma Research Funding: Hansoh Pharma (Inst); Tong Zhou, Speakers' Bureau: AstraZeneca, Roche China, Novartis; Xiongwen Tang, Employment: TopAlliance BioSciences Inc Stock and Other Ownership Interests: TopAlliance BioSciences Inc; Jianjun Yu, Employment: TopAlliance BioSciences Inc, Predicine Stock and Other Ownership Interests: TopAlliance BioSciences Inc, Predicine; Hui Feng, Employment: Shanghai Junshi BioSciences, TopAlliance BioSciences Inc Leadership: Shanghai Junshi BioSciences, TopAlliance BioSciences Inc Stock and Other Ownership Interests: Shanghai Junshi BioSciences Patents, Royalties, Other Intellectual Property: Shanghai Junshi BioSciences Inc patent Travel, Accommodations, Expenses: Shanghai Junshi BioSciences; Sheng Yao Employment: TopAlliance BioSciences Inc, Shanghai Junshi BioSciences Leadership: Shanghai Junshi BioSciences Stock and Other Ownership Interests: Shanghai Junshi BioSciences Patents, Royalties, Other Intellectual Property: Patent applications as employee of TopAlliance Biosciences Inc; Patricia Keegan, Employment: TopAlliance Biosciences. 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.Writing assistanceProfessional writing support for this summary was provided by Joshua Rodman, PhD, of MEDiSTRAVA, an Inizio company, funded by Coherus Biosciences (Redwood City, CA, USA).Ethical disclosureAll patients provide written informed consent before participating in the CHOICE-01 study. The institutional review board at each participating site reviewed and approved the study protocol. The conduct of this trial was compliant with the International Council for Harmonization E6 Guidelines for Good Clinical Practice and principles of the Declaration of Helsinki. The CHOICE-01 study is registered on ClinicalTrials.gov (identifier: NCT03856411).Reviewer disclosuresPatient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.AcknowledgementsThe authors would like to thank all patients participating in the CHOICE-01 study, their families and all healthcare professionals involved in the trial.