Date: 2011-06-06
Type of information:
phase: 3
Announcement: results
Company: Teva Pharmaceutical Industries (Israel)
Product: lipegfilgrastim
Action
mechanism: Lipegfilgrastim (INN; internal code - XM22) is a biosimilar product.
This glyco-PEGylated recombinant human G-CSF was added to the Teva's portfolio through the acquisition of ratiopharm and is a long-acting G-CSF based on glyco-PEGgylation technology, which leads to a prolonged plasma half-life.
The product is designed to provide clinical efficacy and safety profiles which are fully comparable to Neulasta®.
Disease: prevention of chemotherapy-induced neutropenia in breast cancer patients
Therapeutic area: Cancer - Oncology
Country:
Trial details: This multinational, multicenter, randomized, double-blind, controlled Phase III study was designed to evaluate the efficacy and safety of lipegfilgrastin 6mg compared to pegfilgrastim 6mg (Neulasta®) in preventing chemotherapy-induced neutropenia in breast cancer patients receiving 4 cycles of doxorubicin and docetaxel. Approximately 24 hours after the initiation of chemotherapy, 101 patients received a single subcutaneous injection of lipegfilgrastim on each of the 4 cycles. In parallel, 101 patients were treated accordingly with pegfilgrastim. Study results show that the primary outcome measure of reducing the duration of severe neutropenia in cycle 1 was well met. No relevant differences in safety parameters were observed. Further analysis is ongoing.
Latest
news: Teva Pharmaceutical Industries announced that lipegfilgrastim achieved its primary endpoint of reducing the duration of severe neutropenia in a Phase III study designed to evaluate the efficacy and safety of lipegfilgrastim (XM22) compared to pegfilgrastim (Amgen\'s Neulasta®). Initial study results demonstrate that the duration of severe neutropenia (DSN) was similar in both treatment groups and the difference was well below the limit of 1 day, as required by the EMA, and below 0.62 days, as required by the U.S. FDA. Additionally, no significant differences were observed in treatment-emergent adverse events between the two treatment groups. Further analysis of the study results is ongoing.
An additional efficacy and safety study comparing lipegfilgrastim (XM22) to placebo in preventing chemotherapy-induced neutropenia in non-small cell lung cancer patients is currently ongoing, with results expected later this year.
