Kazia Therapeutics Ltd (ASX:KZA (NASDAQ:KZIA) shares have been up as much as 82% after revealing positive interim data from its ongoing phase II study of GDC-0084 in glioblastoma, the most common and most aggressive form of primary brain cancer.
Nine patients participated in Stage 1 of the study, of which eight were evaluable for efficacy.
Progression-free survival (PFS) in this initial group of patients was determined to be 8.4 months.
The existing standard of care, temozolomide, has a reported PFS of around 5.3 months, although cross-study comparisons must always be treated with caution.
Overall survival (OS) could not yet be calculated, with 75% of evaluable patients still alive at the cut-off date for analysis.
In aggregate, these early results provide a strong signal that GDC-0084 may provide clinical benefit in this patient population.
Investors responded positively with securities up as high as 80-cents intra-day, a new 12-month high for the company.
A meaningful OS benefit may emerge as the study matures
Kazia CEO Dr James Garner said: “This is early ‘first look’ data from the study, representing around a third of the total patients to be enrolled, but it has already exceeded our expectations.
“We see a clear signal that GDC-0084 is providing clinical benefit in this group of patients.
“Although it has not yet been possible to calculate overall survival, the fact that the majority of patients in the first stage of the study remain alive more than a year after diagnosis suggests that a meaningful OS benefit may emerge as the study matures.
“That would be a remarkable finding.”
Next steps
Stage 2 of the study continues to enrol patients, and further data is expected early in calendar 2020.
In addition to this ongoing phase II study in glioblastoma, GDC-0084 is also the subject of four other ongoing clinical trials in DIPG and brain metastases, several of which are also expected to report interim data during the early part of calendar 2020.
Given the early positive signal from this study, Kazia intends to accelerate activities to initiate a pivotal study for registration in calendar 2020.
