ASX Announcements
November poster refer patients numbers NEWBIES
''For comparative purposes, in this group of patients, temozolomide improves PFS from 4.4 months to 5.3 months2. It is difficult to precisely compare results between studies, due to differences in patient population, background standard of care, and calculation methodology, but the magnitude of the difference in this case suggests that treatment with GDC-0084 is associated with a clinically beneficial treatment effect.
Other studies of temozolomide in this patient group have reported a ‘headline’ PFS ofbetween 5.13and 7.34months, although much of this variability is attributable to differences in study design and calculation methodology.
Given these considerations, it is not yet possible to precisely quantify the potential treatment advantage of GDC-0084 versus temozolomide. However, Kazia considers that the present results constitute a strong qualitative signal that the drug may provide benefit.
This is early interim data, and potential regulatory approval will almost certainly depend on the findings of a larger, randomised pivotal study.''