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Clinical Trials

Date: 2011-05-31

Type of information:

phase: 2

Announcement: results

Company: Teva Pharmaceutical Industries (Israel)

Product: CG-10639 (Granulocyte Colony Stimulating Factor (G-CSF) - formerly Neugranin)

Action mechanism: biosimilars of pelgrastim

Disease: breast cancer

Therapeutic area: Cancer - Oncology

Country:

Trial details: A Phase II/III study of CG-10639, a long-acting recombinant human albumin-human G-CSF to prevent chemotherapy-induced neutropenia, demonstrated similar outcomes to pegfilgrastim (PEGF), for both efficacy and safety measures in breast cancer patients. The primary endpoint was duration of severe neutropenia (DSN) in days during cycle one of treatment.

Latest news: Teva Pharmaceutical Industries Ltd has announced that data from studies of two investigational Granulocyte Colony Stimulating Factor (G-CSF) compounds in breast cancer patients receiving myelosuppressive chemotherapy will be presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3-7, 2011.
These data showed the non-inferiority of CG- 10639 (40mg and 50mg) to PEGF; a confirmatory Phase III study comparing CG-10639 40mg and PEGF 6mg is currently underway. No clinically relevant immunogenicity with CG-10639 was observed.
Phase II data from a dose-finding study of another Teva investigational compound for G-CSF, XM22, will also be presented at ASCO. These data confirmed greater efficacy based on DSN with higher doses of XM22. While all formulations of XM22 studied (3mg, 4.5mg and 6mg) impacted DSN similarly in the first treatment cycle, a trend for shorter DSN was associated with the higher doses. Treatment-related adverse events were similar between treatment groups. The results supported the use of XM22 6mg in the ongoing Phase III clinical trial program.

Is general: Yes