Monday, Black Diamond Therapeutics, Inc. (NASDAQ:BDTX) reported initial Phase 2 data of BDTX-1535.
The data demonstrated encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor (EGFR)-mutant (EGFRm) non-small cell lung cancer (NSCLC).
"Patients often become resistant to osimertinib with the emergence of on-target resistance EGFR mutations," said Sergey Yurasov, Chief Medical Officer of Black Diamond Therapeutics. "Our preliminary Phase 2 data demonstrate the potential of BDTX-1535 to deliver durable responses for these patients."
AstraZeneca Plc (NASDAQ:AZN) markets osimertinib as Tagrisso.
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.
The preliminary objective response rate (ORR) for the 22 response-evaluable patients was 36%. Nineteen of these 22 patients expressed known osimertinib resistance mutations.
Of these 19 patients, 8 achieved a response (42%): 5 with a confirmed partial response (PR), including one patient who converted from a PR to an unconfirmed complete response (CR) at 8 months (and awaits confirmatory scan); and 3 with an unconfirmed PR at first scan and awaiting a confirmatory scan. An additional 9 patients experienced stable disease.
Encouraging durability was observed, with a duration of response (DOR) of approximately 8 months or more for the first three patients with PR; 14 of 19 remain on therapy. Mean follow-up time is 4.7 months.
Most adverse events were mild or moderate, and no new safety signals were observed.
200 mg daily selected for pivotal clinical development.
Black Diamond continues to enroll patients in the second—and third-line cohorts and in the first-line setting for patients with non-classical EGFR mutations.
In Q1 2025, the company expects to disclose initial results from the first-line cohort and outline potential registrational paths in the recurrent setting based on FDA feedback.
Price Action: BDTX stock is up 2.21% at $4.86 at the last check on Monday.
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