{"doi":"10.1016/j.ejca.2024.115119","title":"Long-term outcomes among patients who respond within the first year to nivolumab plus ipilimumab or nivolumab monotherapy: A pooled analysis in 935 patients","abstract":"PURPOSE: To investigate the predictive value of RECIST response within 3, 6, or 12 months on long-term survival, and explore differences between nivolumab+ipilimumab and nivolumab monotherapy, we analyzed pooled 5-year data of 935 responder and non-responder patients at various time points after treatment initiation in CheckMate 069, 066, and 067 studies. PATIENTS AND METHODS: Treatment-naive advanced melanoma patients received nivolumab+ipilimumab or nivolumab monotherapy. To decrease immortal time bias, 3-, 6-, or 12-month overall survival (OS) and progression-free survival (PFS) landmark analyses were performed. Association between characteristics and response was evaluated by univariate and multivariate analyses. RESULTS: Response rates at any time were 58 % (239/409) for nivolumab+ipilimumab and 44 % (230/526) for nivolumab monotherapy. In 12-month landmark analyses, 5-year OS rates for responders versus non-responders were 82 % versus 40 % with nivolumab+ipilimumab (HR=0.23 [95 % CI, 0.15-0.35]) and 76 % versus 32 % with nivolumab monotherapy (HR=0.22 [95 % CI, 0.16-0.31]). PFS rates were 83 % versus 32 % and 69 % versus 46 %, respectively. Similar strong associations between response at 3 and 6 months and 5-year OS and PFS were also observed with more than 70 % of the responses observed in the first 3 months. Response rates correlated with baseline LDH and PD-L1 status by multivariate analysis but the association between response and long-term survival was maintained in landmark analyses even among patients with high LDH and low PD-L1 expression. CONCLUSION: Clinical response evaluated in the first months of therapy is a strong predictor of long-term survival, even in patients with poor prognostic biomarkers.","journal":"European Journal of Cancer","year":2024,"id":433397,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":14,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9341,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2024-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1239120,"name":"G.V. Long","orcid":null,"position":1,"is_corresponding":false},{"id":1238685,"name":"John O. Larkin","orcid":"0000-0003-4218-3856","position":2,"is_corresponding":false},{"id":3666,"name":"Jedd D. Wolchok","orcid":"0000-0001-6718-2222","position":3,"is_corresponding":false},{"id":1239121,"name":"J.C. Hassel","orcid":null,"position":4,"is_corresponding":false},{"id":1239122,"name":"D. Schadendorf","orcid":null,"position":5,"is_corresponding":false},{"id":1239123,"name":"F.S. Hodi","orcid":null,"position":6,"is_corresponding":false},{"id":1239124,"name":"C. Lebbé","orcid":null,"position":7,"is_corresponding":false},{"id":68941,"name":"Jean‐Jacques Grob","orcid":"0000-0002-0667-153X","position":8,"is_corresponding":false},{"id":920775,"name":"John Hyngstrom","orcid":"0000-0002-4833-3838","position":9,"is_corresponding":false},{"id":68923,"name":"John Wagstaff","orcid":"0000-0002-1140-5981","position":10,"is_corresponding":false},{"id":731200,"name":"Jason Chesney","orcid":"0000-0003-0217-8278","position":11,"is_corresponding":false},{"id":1239125,"name":"M.O. Butler","orcid":null,"position":12,"is_corresponding":false},{"id":560783,"name":"Oliver Bechter","orcid":"0000-0003-0667-3284","position":13,"is_corresponding":false},{"id":1239126,"name":"I. Márquez-Rodas","orcid":null,"position":14,"is_corresponding":false},{"id":345307,"name":"Anna C. Pavlick","orcid":"0000-0001-7088-0742","position":15,"is_corresponding":false},{"id":1238686,"name":"Piyush Durani","orcid":"0000-0002-4388-9570","position":16,"is_corresponding":false},{"id":1239127,"name":"Melanie Pe Benito","orcid":null,"position":17,"is_corresponding":false},{"id":27080,"name":"P. Wang","orcid":"0000-0002-1024-0687","position":18,"is_corresponding":false},{"id":68931,"name":"Michael A. Postow","orcid":"0000-0002-3367-7961","position":19,"is_corresponding":false},{"id":1239128,"name":"P.A. Ascierto","orcid":null,"position":20,"is_corresponding":false},{"id":58598,"name":"Caroline Robert","orcid":"0000-0002-9493-0238","position":0,"is_corresponding":true}],"reference_count":18,"raw_metadata":null,"created_at":"2026-07-19T01:59:44.444627Z","pmid":"39612757","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}