Black Diamond Therapeutics(US:BDTX) Newsfilter·2024-06-01 14:00Core Insights - Black Diamond Therapeutics presented promising results from the Phase 1 dose escalation trial of BDTX-1535 in recurrent glioblastoma (GBM) patients, showing a favorable safety profile and encouraging anti-tumor activity [1][2][3] Group 1: Clinical Trial Results - The Phase 1 trial demonstrated a duration of treatment exceeding the typical two to four months expected in recurrent GBM, with good safety and tolerability at therapeutic doses [2] - Among 19 efficacy evaluable patients, several experienced stable disease with promising durability [3] - Initial data from a Phase 0/1 "trigger" trial indicated that BDTX-1535 achieved clinically meaningful drug levels in brain tumor tissue, exceeding the pre-specified PK threshold of 4.1 nM [4][10] Group 2: Safety and Tolerability - BDTX-1535 was generally well tolerated, with treatment-related adverse events primarily mild to moderate, including rash, diarrhea, and fatigue [5][10] - No grade 3 or higher treatment-related adverse events were reported at doses of BDTX-1535 ≤100 mg/day, with only one grade 3 rash observed at 200 mg [5] Group 3: Pharmacokinetics and Pharmacodynamics - Eight out of nine patients (88.9%) exceeded the PK threshold of 4.1 nM unbound drug concentration, with average concentrations of 11.9 nM for the 200 mg dose and 18.8 nM for the 400 mg dose [10] - BDTX-1535 was associated with suppression of EGFR-mediated signaling, as determined by several pharmacodynamic markers [10] Group 4: Future Directions - The company is considering further trials of BDTX-1535 in newly diagnosed patients with confirmed EGFR mutations based on the clinical activity observed [6]