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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.
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.
In 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.
The 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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
202 randomised.
Mean; non-inferior to pegfilgrastim per the authors and the Lonquex product information · Mean
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Duration of severe neutropenia in cycle 1primary | Lipegfilgrastim 6 mg | 101 | 0.7 days | - | 0.126 | link |
| Pegfilgrastim 6 mg | 101 | 0.8 days |
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Pegfilgrastim, Breast cancer (all types).
Shares Lipegfilgrastim, Pegfilgrastim.
Shares Teva Pharmaceuticals, Pegfilgrastim.