On April 24, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported forthcoming presentations during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4 in Chicago, IL (Press release, Black Diamond Therapeutics, APR 24, 2024, View Source [SID1234642275]). The two poster presentations describe data for BDTX-1535 in patients with recurrent glioblastoma (GBM) across two clinical trials: a Phase 1 dose escalation trial, for which topline data were released in December 2023, and a Phase 0/1 "trigger" ("window of opportunity") trial conducted as an Investigator Sponsored Trial at the Ivy Brain Tumor Center (NCT06072586).
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Presentation details are as follows:
Title: Phase 1 Study of BDTX-1535, an Oral 4th Generation Covalent EGFR Inhibitor, in Patients with Recurrent Glioblastoma: Preliminary Dose Escalation Results
Speaker/Author: Dr. Patrick Wen, Dana Farber Cancer Institute and Harvard Medical School
Date and Time: Saturday, June 1, 2024, 9:00 AM – 12:00 PM CDT
Abstract: 2068
Poster: #367
Title: A Phase 0/1 ‘Trigger’ Trial of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Patients with EGFR Alterations or Fusions
Speaker/Author: Yoshie Umemura, MD, BS, Ivy Brain Tumor Center and Barrow Neurological Institute
Date and Time: Saturday, June 1, 2024, 9:00 AM – 12:00 PM CDT
Abstract: 2069
Poster: #368
Posters will become available on June 1, 2024 at 10:00 AM EDT on the Black Diamond Therapeutics website here.
About BDTX-1535
BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC), including classical driver mutations, non-classical driver mutations, and the acquired resistance C797S mutation. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 oncogenic EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A "window of opportunity" trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients with NSCLC (NCT05256290).