Shares of Black Diamond Therapeutics, Inc. (NASDAQ: BDTX) skyrocketed 235.87% on Tuesday following the release of promising clinical data. The company unveiled the initial results from the dose escalation portion of their Phase 1 clinical study on BDTX-1535, a potential treatment for non-small cell lung cancer (NSCLC) and glioblastoma multiforme (GBM).
The new data showcased clear evidence of BDTX-1535’s effectiveness in treating NSCLC patients with both acquired resistance and intrinsic driver EGFR mutations. The study enrolled 51 patients who received BDTX-1535 up until May 20, 2023. The pharmacokinetic profile of the drug showed a consistent increase in exposure and a half-life of approximately 15 hours, making it suitable for daily dosing. Notably, the treatment was generally well-tolerated by NSCLC and GBM patients, with mild to moderate side effects including rash, diarrhea, stomatitis, paronychia, nausea, and fatigue. Importantly, no unexpected safety concerns were identified during the dose escalation phase.
Among the 12 NSCLC patients with measurable disease at the beginning of the study, five demonstrated a confirmed partial response based on radiographic confirmation by June 16, 2023. In addition, one patient showed an unconfirmed partial response, while the remaining six patients maintained stable disease.
Looking ahead, Black Diamond Therapeutics plans to initiate expansion cohorts in the latter half of 2023. These cohorts will assess the overall response rate (ORR) according to RECIST 1.1 criteria in NSCLC patients who have acquired resistance and intrinsic driver mutations after progressing on a third-generation EGFR inhibitor. Furthermore, the company aims to provide an update on the Phase 1 dose escalation data for BDTX-1535 in recurrent GBM patients during the fourth quarter of 2023.
BDTX Black Diamond Therapeutics NASDAQ: BDTX
