Positive Interim Efficacy Data from GDC-0084 Phase II Study in Glioblastoma Released at SNO Conference

SYDNEY, Nov. 25, 2019 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to share with investors interim data from its ongoing phase II study of GDC-0084 in glioblastoma, the most common and most aggressive form of primary brain cancer. This data is the subject of a poster presentation at the annual meeting of the Society for Neuro-Oncology (SNO), held in Phoenix, AZ from 20 - 24 November 2019.

Key Points

• Data from first nine patients in the study; total study will be around 29 patients
• Median progression-free survival (PFS) calculated at 8.4 months, implying that GDC-0084 may delay progression of glioblastoma
• Median overall survival (OS) could not yet be calculated due to insufficient death events on study. 75% of evaluable patients remained alive at analysis cut-off date
• As reported in May 2019, a maximum tolerated dose (MTD) of 60mg was established, which is higher than the 45mg dose determined in an earlier phase I study in late-stage patients

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^[1], 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.

The safety of GDC-0084 was also broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and rash among the most common drug-related toxicities. Two dose-limiting toxicities (DLTs) were observed at a dose of 75mg, and these were hyperglycaemia and oral mucositis.

Professor Patrick Wen from Dana-Farber Cancer Institute, who was the lead author on the poster presentation, commented, "There is an urgent need for new therapies in glioblastoma. GDC-0084 has the potential to be an important new addition to the treatment of this very challenging disease. My colleagues and I look forward to examining further data as the study progresses."

Kazia CEO, Dr James Garner, added, "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."

The poster can be downloaded from Kazia's website via: https://www.kaziatherapeutics.com/researchpipeline/gdc-0084.

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 and will share more detailed plans with shareholders in the near future.

Investor Conference Call

Kazia is pleased to invite investors to attend a conference call to discuss the results further.

The call will be held on Tuesday 26 November 2019 at 9:00am, Sydney time (AEDT), which is 2pm on Monday 25 November 2019 in San Francisco (PST) and 5pm on Monday 25 November 2019 in New York (EST). Dial-in details are provided below:-

Professor Ben Ellingson Delivers Oral Presentation on Analysis of Phase I Imaging Data

In addition to the poster presentation for the ongoing phase II study, Professor Ben Ellingson, Director of the UCLA Brain Tumor Imaging Laboratory, was invited to give an oral presentation at the SNO conference on a retrospective analysis of the phase I study of GDC-0084 in recurrent glioma that was completed by Genentech.

Professor Ellingson's analysis showed that specific changes on MRI and PET scans correlated closely with the concentration of GDC-0084 in the patient's blood. Moreover, the data showed that this specific signature on MRI and PET scans was associated with longer progression-free survival (PFS). The importance of this data is that it strengthens the empirical connection between the concentration of GDC-0084, its effect on the biology of the tumour, and the clinical outcome for the patient. This strongly supports Kazia's understanding of the mechanism of action of GDC-0084 and provides further confirmation that the drug is active.

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