{"entity":{"id":"xm22-03","kind":"trial","name":"XM22-03","aka":["XM22 03","EudraCT 2009-015999-10"],"tldr":"XM22-03 showed that lipegfilgrastim, a once-per-cycle injection that boosts white blood cells, kept the spell of dangerously low white cells after chemotherapy as short as the standard booster pegfilgrastim did in people with breast cancer; it was one of the two main studies behind the EU approval of Lonquex.","summary":"XM22-03 was a randomised, double-blind, active-controlled phase 3 non-inferiority trial of lipegfilgrastim versus pegfilgrastim in chemotherapy-naive patients with high-risk stage II, III or IV breast cancer receiving doxorubicin plus docetaxel. Patients received a single subcutaneous 6 mg dose of either drug on day 2 of each 21-day cycle for up to four cycles. The primary endpoint was the duration of severe neutropenia in cycle 1.\n\nIn the BMC Cancer 2013 report, mean duration of severe neutropenia in cycle 1 was 0.7 days with lipegfilgrastim and 0.8 days with pegfilgrastim (p = 0.126 for the between-arm comparison), and 56 percent versus 49 percent of patients had no severe neutropenia in cycle 1. Febrile neutropenia in the efficacy population occurred in no patient on lipegfilgrastim and three on pegfilgrastim, all in cycle 1. Drug-related adverse events in the safety population occurred in 28 percent versus 26 percent. The authors concluded that lipegfilgrastim 6 mg was as effective as pegfilgrastim.\n\nThe Lonquex product information names the study XM22-03, describes it as the first of two pivotal phase 3 studies (202 patients randomised 1:1) and states that it showed non-inferiority for the primary endpoint. It was registered as EudraCT 2009-015999-10; a ClinicalTrials.gov search for lipegfilgrastim and Lonquex found no record of it.","status":"positive","asOf":"2026-09-24","links":[{"label":"BMC Cancer 2013","url":"https://doi.org/10.1186/1471-2407-13-386"},{"label":"Lonquex EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex"}],"tags":[],"related":[],"cancers":["breast-cancer"],"sections":["supportive-care"],"technologies":[],"targets":[],"drugs":["lipegfilgrastim","pegfilgrastim"],"companies":["teva"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-xm22-03-bondarenko-bmc-cancer-2013"],"journals":[],"dependsOn":[],"notes":[],"phase":"3","setting":"High-risk stage II to IV breast cancer starting doxorubicin plus docetaxel: a single subcutaneous 6 mg dose of lipegfilgrastim versus pegfilgrastim on day 2 of each 21-day cycle, for up to four cycles","sponsor":"Teva Ratiopharm","result":"Cycle 1 mean duration of severe neutropenia 0.7 days vs 0.8 days with pegfilgrastim (p = 0.126); the authors and the Lonquex product information report non-inferiority on this primary endpoint.","yearReported":2013,"enrolled":202,"enrolledBasis":"randomised","enrolledNote":"The BMC Cancer 2013 abstract reports 101 patients randomly assigned to each arm (202 in total) and the Lonquex product information describes the same 202; the study was registered as EudraCT 2009-015999-10 and has no ClinicalTrials.gov record, so there is no registry enrolment figure to compare.","outcomes":[{"endpoint":"Duration of severe neutropenia in cycle 1","primary":true,"unit":"days","arms":[{"name":"Lipegfilgrastim 6 mg","n":101,"value":0.7,"note":"Mean; non-inferior to pegfilgrastim per the authors and the Lonquex product information"},{"name":"Pegfilgrastim 6 mg","n":101,"value":0.8,"note":"Mean"}],"p":"0.126","source":"https://doi.org/10.1186/1471-2407-13-386"}],"replication":"The second pivotal, XM22-04 (Volovat 2015, placebo-controlled, non-small-cell lung cancer, 375 patients), is not yet recorded here."},"route":"/trials/xm22-03/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"section":[{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"drug":[{"id":"lipegfilgrastim","kind":"drug","name":"Lipegfilgrastim","route":"/drugs/lipegfilgrastim/"},{"id":"pegfilgrastim","kind":"drug","name":"Pegfilgrastim","route":"/drugs/pegfilgrastim/"}],"company":[{"id":"teva","kind":"company","name":"Teva Pharmaceuticals","route":"/companies/teva/"}],"paper":[{"id":"paper-xm22-03-bondarenko-bmc-cancer-2013","kind":"paper","name":"Efficacy and safety of lipegfilgrastim versus pegfilgrastim in breast cancer patients receiving doxorubicin and docetaxel (XM22-03)","route":"/key-papers/paper-xm22-03-bondarenko-bmc-cancer-2013/"}]}}