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Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM
Initial results show promising clinical activity in heavily pretreated patients 22 patients evaluable for efficacy: 3 patients on therapy longer than 10
About this update from Black Diamond Therapeutics, Inc.
[{"type":"text","content":"Initial results show promising clinical activity in heavily pretreated patients 22 patients evaluable for efficacy: 3 patients on therapy longer than 10 months, 1 patient longer than 6 months, and 5 patients longer than 4 months 19 patients with measurable disease by RANO criteria: 1 patient with confirmed partial response and 8 patients with stable disease BDTX-1535 generally well tolerated, consistent with prior disclosures and no new safety signals observed “Window of opportunity” trial enrolling patients to assess PK in brain tissue CAMBRIDGE, Mass., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced topline results from the dose escalation portion of the Phase 1 clinical trial of BDTX-1535 in patients with recurrent glioblastoma (GBM) who expressed epidermal growth factor receptor (EGFR) alterations at the time of their initial diagnosis. BDTX-1535, a fourth-generation, brain-penetrant, covalent EGFR inhibitor, is under investigation in a Phase 1 clinical trial for the treatment of patients with non-small cell lung cancer (NSCLC) or GBM. “These initial results in patients with recurrent GBM are encouraging, as there are no approved therapies available for those who progress following initial treatment, and there is strong rationale for a brain penetrant, covalent EGFR inhibitor such as BDTX-1535 to have a meaningful impact in earlier lines of therapy,” said Patrick Wen, M.D., Director of The Center for Neuro-Oncology at Dana-Farber Cancer Institute. Clinical data as of November 2023 reflect 27 patients with recurrent GBM who received a range of doses spanning 15mg to 400mg once daily (QD) in the dose escalation cohort. Combined pharmacokinetic (PK) and safety data from these 27 patients with GBM and 27 patients with NSCLC were previously presented on October 14, 2023 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. No new safety signals were observed; adverse events were consistent with the EGFR tyrosine kinase inhibitor (TKIs) class of drugs, including primarily Grade 1 and 2 diarrhea and rash. Patients with NSCLC dosed at 100mg QD or greater demonstrated confirmed partial respons...