Precision-oncology company Black Diamond Therapeutics has announced topline positive data from the Phase I clinical trial investigating BDTX-1535 in patients with recurrent glioblastoma (GBM). 

As of last month, the data analysis assessed 27 patients with recurrent GBM who had all been heavily pre-treated with treatments such as chemotherapy, bevacizumab, or checkpoint inhibitors.  

Out of these patients, 22 were started at escalated to a dose of 100mg or above and were evaluated for efficacy. Eight patients experienced stable disease and one patient achieved a confirmed partial response, staying on the treatment for four months at a dose of 200mg. 

The patient who remains on therapy the longest has been on BDTX-1535 at 100mg with prolonged disease stabilisation for over 15 months. This patient had previously progressed after three months of treatment with temozolomide.  

The non-randomised, open-label, multi-centre Phase I study (NCT05256290) is evaluating the safety and preliminary antitumor activity of BDTX-1535 in patients with GBM or non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) alterations and who have disease progression following standard of care.  

The primary outcomes are dose escalation and dose expansion to determine the maximum tolerated dose and recommended Phase II dose, as well as the overall response rate. The trial is ongoing, with a primary completion date in June 2024, according to registry. 

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In the announcement accompanying the data, the director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute Patrick Wen said: “These initial results in patients with recurrent GBM are encouraging, as there are no approved therapies available for those who progress following initial treatment. 

BDTX-1535 is a small molecule epidermal growth factor receptor MasterKey inhibitor. Wen highlighted the impact of a brain penetrant such as BDTX-1535 in earlier lines of therapy.  

In June of this year, Black Diamond announced positive results from the first portion of the trial, with BDTX-1535 demonstrating anti-tumour activity in NSCLC patients. Following the news, the company offered 15 million shares of its common stock set at $5.00 per share, which is expected to raise $75m. 

According to GlobalData’s Pharma Intelligence Center, Black Diamond has three other drugs in the pipeline, including BDTX-4933, which is a Phase I drug being investigated for the treatment of central nervous system (CNS) tumours.  

GlobalData is the parent company of Clinical Trials Arena.  

Both BDTZ-1535 and BDTX-4933 are developed using Black Diamond’s Mutation-Allostery-Pharmacology (MAP) technology platform, which is used to identify oncogenic mutations that promote cancer.