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Black Diamond Therapeutics Announces Initial Dose Escalation Data Demonstrating Anti-Tumor Activity of BDTX-1535 in Non-Small Cell Lung Cancer Patients Across Multiple EGFR Mutation Families
BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrates clinical proof of activity for MasterKey mutation-targeting approach
About this update from Black Diamond Therapeutics, Inc.
[{"type":"text","content":"BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrates clinical proof of activity for MasterKey mutation-targeting approach based on radiographic tumor responses and circulating tumor DNA changes in NSCLC patients with acquired resistance and intrinsic driver EGFR mutations Confirmed radiographic partial response by RECIST 1.1 achieved across predicted therapeutic doses in 5 of 12 NSCLC patients in subgroup with measurable disease, who underwent post baseline tumor assessment by RECIST1.1; one additional patient demonstrated unconfirmed PR awaiting confirmation, while the remaining six patients had stable diseaseExpansion cohorts expected to commence in second half of 2023 to assess ORR by RECIST 1.1 in NSCLC patients with EGFR-acquired resistance and intrinsic driver mutations after progression on a third-generation EGFR inhibitorFavorable tolerability profile observed with once-daily therapeutic doses to be further explored in NSCLC expansion cohortsUpdate on Phase 1 dose escalation data in GBM cohort anticipated in the fourth quarter of 2023Company to host investor conference call and webcast today at 8:00 a.m. ET CAMBRIDGE, Mass. and NEW YORK, June 27, 2023 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, today announced initial clinical data from the dose escalation portion of the Phase 1 clinical study of BDTX-1535. BDTX-1535 is an investigational fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor being developed for the treatment of non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM). The new data from the dose escalation portion of the Phase 1 study demonstrated clinical proof of activity of BDTX-1535 in NSCLC patients harboring both acquired resistance and intrinsic driver EGFR mutations. “These initial safety and clinical activity data support the continued development of BDTX-1535 as a potential first and best-in-class treatment option for osimertinib-resistant NSCLC patients. Importantly, BDTX-1535 is the first EGFR TKI to show radiographic responses across NSCLC patients whose cancers are driven by diverse mutation families including acquired resistance mutat...