Black Diamond Therapeutics Inc BDTX announced initial clinical data from the dose escalation portion of the Phase 1 clinical study of BDTX-1535 for 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 the activity of BDTX-1535 in NSCLC patients harboring both acquired resistance and intrinsic driver EGFR mutations.
As of the cut-off date, May 20, 2023, 51 patients were treated with BDTX-1535.
The BDTX-1535 PK profile exhibited a linear increase in exposure. Its half-life is approximately 15 hours, making it suitable for a daily dosing schedule. The drug was generally well-tolerated by NSCLC and GBM patients.
The most common side effects were mild to moderate rash, diarrhea, stomatitis, paronychia, nausea, and fatigue. No unexpected safety signals were identified during dose escalation.
As of June 16, 2023, five of the 12 NSCLC patients with measurable disease at the study start showed radiographic confirmed partial response.
One additional patient showed unconfirmed PR, while the remaining six had stable disease.
Expansion cohorts are expected to commence in the 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 inhibitor.
The company has planned to provide an update on BDTX-1535 Phase 1 dose escalation data in recurrent GBM patients in the fourth quarter of 2023.
Price Action: BDTX shares are up 84.20% at $3.39 on the last check Tuesday.
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