Monday, Black Diamond Therapeutics, Inc. BDTX reported preliminary Part 2 knowledge of BDTX-1535.
The info demonstrated encouraging scientific responses and sturdiness of BDTX-1535 in sufferers with relapsed/refractory epidermal development issue receptor (EGFR)-mutant (EGFRm) non-small cell lung most cancers (NSCLC).
“Sufferers typically grow to be proof against osimertinib with the emergence of on-target resistance EGFR mutations,” stated Sergey Yurasov, Chief Medical Officer of Black Diamond Therapeutics. “Our preliminary Part 2 knowledge show the potential of BDTX-1535 to ship sturdy responses for these sufferers.”
AstraZeneca Plc AZN markets osimertinib as Tagrisso.
Preliminary response fee and sturdiness had been assessed in 27 sufferers at 200 mg with an August 17, 2024, knowledge cutoff, together with 22 response-evaluable sufferers who met protocol eligibility standards.
The preliminary goal response fee (ORR) for the 22 response-evaluable sufferers was 36%. Nineteen of those 22 sufferers expressed recognized osimertinib resistance mutations.
Of those 19 sufferers, 8 achieved a response (42%): 5 with a confirmed partial response (PR), together with one affected person who transformed from a PR to an unconfirmed full response (CR) at 8 months (and awaits confirmatory scan); and three with an unconfirmed PR at first scan and awaiting a confirmatory scan. An extra 9 sufferers skilled steady illness.
Encouraging sturdiness was noticed, with a period of response (DOR) of roughly 8 months or extra for the primary three sufferers with PR; 14 of 19 stay on remedy. Imply follow-up time is 4.7 months.
Most hostile occasions had been gentle or average, and no new security indicators had been noticed.
200 mg every day chosen for pivotal scientific growth.
Black Diamond continues to enroll sufferers within the second—and third-line cohorts and within the first-line setting for sufferers with non-classical EGFR mutations.
In Q1 2025, the corporate expects to reveal preliminary outcomes from the first-line cohort and description potential registrational paths within the recurrent setting based mostly on FDA suggestions.
Worth Motion: BDTX inventory is up 2.21% at $4.86 on the final test on Monday.
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