leadf
logo-loader
viewKazia Therapeutics Ltd

Kazia Therapeutics shares surge after positive early phase II study results for GDC-0084 in brain cancer patients

Majority of patients in the first stage of the study remain alive more than a year after diagnosis of glioblastoma, an aggressive form of primary brain cancer.

Kazia Therapeutics Ltd - Kazia Therapeutics shares surge after positive early results for GDC-0084 in brain cancer patients
Stage 2 of the study continues to enrol patients, and further data is expected early in calendar 2020

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.

Quick facts: Kazia Therapeutics Ltd

Price: 1.37 AUD

ASX:KZA
Market: ASX
Market Cap: $129.63 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Kazia Therapeutics Ltd named herein, including the promotion by the Company of Kazia Therapeutics Ltd in any Content on the Site, the Company...

FOR OUR FULL DISCLAIMER CLICK HERE

Kazia Therapeutics moves into operational phase of pivotal study for...

Kazia Therapeutics Ltd's (ASX:KZA) James Garner speaks to Proactive's Andrew Scott soon after announcing they've executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to begin participation in the GBM AGILE pivotal study in glioblastoma. The study is set to open...

on 21/10/20

2 min read