*September 2024*
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. More info on this trial here.
