Black Diamond Therapeutics Inc
For the period ended Sep 23, 2024. Filed Sep 23, 2024.
View on SEC.govAbout this filing
A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
Sep 23, 2024 · Filed Sep 23, 2024
Use the contents to explore the available documents and sections.
Contents
Phase 2 Preliminary Data Overview
The Phase 2 trial began in August 2023, and enrolled relapsed/refractory patients with non-classical EGFR mutations (“NCMs”) (Cohort 1) and those with C797S resistance mutations (Cohort 2). Safety assessment and dose selection were based upon the first 40 patients randomized to receive BDTX-1535 once daily at either 100 mg or 200 mg across both Cohorts. Preliminary response rate and durability were assessed in 27 patients at 200 mg with an August 17, 2024, data cutoff, including 22 response-evaluable patients who met protocol eligibility criteria.
Key Takeaways:
| · | 200 mg daily selected for pivotal clinical development. Dose selection was based primarily on pharmacokinetics, safety and tolerability data from 20 patients at 100 mg, and 20 patients at 200 mg. |
| · | Favorable tolerability profile at 200 mg, consistent with prior BDTX-1535 clinical data. The majority of adverse events were mild or moderate, and no new safety signals were observed. The most common on-target treatment-related adverse events were rash (70%) and diarrhea (35%). There were two cases of grade 3 rash, and no reported cases of grade 4 rash or grade 3/4 diarrhea. |
| · | Preliminary objective response rate (“ORR”) of 42% achieved in 19 patients. For the 22 response-evaluable patients, the preliminary ORR was 36%. 19 of these 22 patients expressed known osimertinib resistance mutations: either C797S or P-loop alpha-C helix compressing (a major subset of NCMs). Of these 19 patients, eight achieved a response (42%): five with a confirmed partial response (“PR”), including one patient who converted from a PR to an unconfirmed complete response at 8 months (and awaits confirmatory scan); and three with an unconfirmed PR at first scan and awaiting a confirmatory scan. An additional nine patients experienced stable disease. |
| · | Encouraging durability observed, with duration of response of approximately 8 months or more for first three patients with PR; 14 of 19 patients remain on therapy. Mean follow-up time is 4.7 months. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.