{"doi":"10.1056/nejmoa2309457","title":"First-Line Selpercatinib or Chemotherapy and Pembrolizumab in <i>RET</i> Fusion–Positive NSCLC","abstract":"BACKGROUND: fusion-positive non-small-cell lung cancer (NSCLC) in a nonrandomized phase 1-2 study. METHODS: In a randomized phase 3 trial, we evaluated the efficacy and safety of first-line selpercatinib as compared with control treatment that consisted of platinum-based chemotherapy with or without pembrolizumab at the investigator's discretion. The primary end point was progression-free survival assessed by blinded independent central review in both the intention-to-treat-pembrolizumab population (i.e., patients whose physicians had planned to treat them with pembrolizumab in the event that they were assigned to the control group) and the overall intention-to-treat population. Crossover from the control group to the selpercatinib group was allowed if disease progression as assessed by blinded independent central review occurred during receipt of control treatment. RESULTS: In total, 212 patients underwent randomization in the intention-to-treat-pembrolizumab population. At the time of the preplanned interim efficacy analysis, median progression-free survival was 24.8 months (95% confidence interval [CI], 16.9 to not estimable) with selpercatinib and 11.2 months (95% CI, 8.8 to 16.8) with control treatment (hazard ratio for progression or death, 0.46; 95% CI, 0.31 to 0.70; P<0.001). The percentage of patients with an objective response was 84% (95% CI, 76 to 90) with selpercatinib and 65% (95% CI, 54 to 75) with control treatment. The cause-specific hazard ratio for the time to progression affecting the central nervous system was 0.28 (95% CI, 0.12 to 0.68). Efficacy results in the overall intention-to-treat population (261 patients) were similar to those in the intention-to-treat-pembrolizumab population. The adverse events that occurred with selpercatinib and control treatment were consistent with those previously reported. CONCLUSIONS: fusion-positive NSCLC. (Funded by Eli Lilly and others; ClinicalTrials.gov number, NCT04194944.).","journal":"New England Journal of Medicine","year":2023,"id":315115,"datarank":4.624837319963077,"base_score":5.389071729816501,"endowment":5.389071729816501,"self_citation_contribution":0.8083607594724752,"citation_network_contribution":3.8164765604906017,"self_endowment_contribution":0.8083607594724752,"citer_contribution":3.8164765604906017,"corpus_percentile":null,"corpus_rank":null,"citation_count":218,"citer_count":100,"citers_with_citation_signal":100,"citers_with_endowment":100,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9567,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04194944"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":84448,"name":"Benjamin Solomon","orcid":"0000-0003-3059-5730","position":1,"is_corresponding":false},{"id":629766,"name":"Herbert H. Loong","orcid":"0000-0002-6607-1106","position":2,"is_corresponding":false},{"id":13143,"name":"Keunchil Park","orcid":"0000-0002-4846-7449","position":3,"is_corresponding":false},{"id":1015050,"name":"M. Pérol","orcid":"0000-0002-3296-423X","position":4,"is_corresponding":false},{"id":900868,"name":"Edurne Arriola","orcid":"0000-0001-8960-7519","position":5,"is_corresponding":false},{"id":32713,"name":"Silvia Novello","orcid":"0000-0001-7653-9748","position":6,"is_corresponding":false},{"id":1015051,"name":"Baohui Han","orcid":"0000-0002-3950-3030","position":7,"is_corresponding":false},{"id":7196,"name":"Jianying Zhou","orcid":"0000-0002-8924-935X","position":8,"is_corresponding":false},{"id":3218,"name":"Andrea Ardizzoni","orcid":"0000-0003-2678-0714","position":9,"is_corresponding":false},{"id":1015771,"name":"M. Perez Mak","orcid":null,"position":10,"is_corresponding":false},{"id":1015052,"name":"Fernando C. Santini","orcid":"0000-0002-6541-8374","position":11,"is_corresponding":false},{"id":247608,"name":"Yasir Y. Elamin","orcid":"0000-0002-5312-909X","position":12,"is_corresponding":false},{"id":230273,"name":"Alexander Drilon","orcid":"0000-0001-6806-9061","position":13,"is_corresponding":false},{"id":84443,"name":"Jürgen Wolf","orcid":null,"position":14,"is_corresponding":false},{"id":454293,"name":"Nalin Payakachat","orcid":"0000-0002-9526-5356","position":15,"is_corresponding":false},{"id":701365,"name":"Minji K. Uh","orcid":null,"position":16,"is_corresponding":false},{"id":1015772,"name":"Deborah Rajakumar","orcid":null,"position":17,"is_corresponding":false},{"id":1015053,"name":"Hongmei Han","orcid":"0000-0002-0494-6624","position":18,"is_corresponding":false},{"id":1015054,"name":"Tarun Puri","orcid":"0000-0003-2399-4362","position":19,"is_corresponding":false},{"id":840883,"name":"Victoria Soldatenkova","orcid":null,"position":20,"is_corresponding":false},{"id":858340,"name":"Aimee Bence Lin","orcid":null,"position":21,"is_corresponding":false},{"id":1015773,"name":"Boris K. 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