Black Diamond Therapeutics' Lead Drug Candidate Shows Initial Anti-tumor Activity In Certain Type Of Lung Cancer Resistant To AstraZeneca's Drug
Black Diamond Therapeutics' Lead Drug Candidate Shows Initial Anti-tumor Activity In Certain Type Of Lung Cancer Resistant To AstraZeneca's Drug
Monday, Black Diamond Therapeutics, Inc. (NASDAQ:BDTX) reported initial Phase 2 data of BDTX-1535.
週一，black diamond therapeutics公司（NASDAQ:BDTX）報告了BDTX-1535的初步2期數據。
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).
數據顯示BDTX-1535在轉歸/難治性表皮生長因子受體 (EGFR)-突變（EGFRm）非小細胞肺癌（NSCLC）患者中表現出鼓舞人心的臨床反應和持久性。
"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."
「患者經常因出現靶標耐藥性EGFR突變而對奧西美替尼產生耐藥性，」black diamond therapeutics的首席醫療官Sergey Yurasov表示。「我們初步的2期數據顯示了BDTX-1535爲這些患者提供持久反應的潛力。」
AstraZeneca Plc (NASDAQ:AZN) markets osimertinib as Tagrisso.
阿斯利康（NASDAQ:AZN）將奧西美替尼營銷爲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.
在2024年8月17日數據截止日期，對200毫克劑量的27位患者進行了初步的反應率和持久性評估， 包括符合協議資格標準並且可評價反應的22位患者。
The preliminary objective response rate (ORR) for the 22 response-evaluable patients was 36%. Nineteen of these 22 patients expressed known osimertinib resistance mutations.
22位可評價反應的患者的初步客觀反應率（ORR）爲36%。其中19位患者表達了已知奧西美替尼耐藥突變。
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.
在這19位患者中，有8位達到了反應（42%）：5位確認爲部分反應（PR），其中一位患者在8個月時從PR轉變爲未經證實的完全反應（CR）（並等待確認掃描）；另外3位在首次掃描時爲未經證實的PR，並正在等待確認掃描。另外9位患者保持穩定病情。
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.
鼓舞人心的持久性是可觀察到的，前三位PR患者的反應持續時間（DOR）約爲8個月或更長；19位中有14位仍在接受治療。平均隨訪時間爲4.7個月。
Most adverse events were mild or moderate, and no new safety signals were observed.
大多數不良事件爲輕度或中度，並且沒有觀察到新的安全信號。
200 mg daily selected for pivotal clinical development.
每日選擇使用200毫克進行關鍵臨床開發。
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.
Black Diamond繼續在第二和第三線隊列以及首線隊列中招募患者，用於非經典EGFR突變的患者。
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.
到2025年第一季度，該公司預計將公佈首線隊列的初步結果，並根據FDA的反饋概述在復發設置中的潛在註冊途徑。
Price Action: BDTX stock is up 2.21% at $4.86 at the last check on Monday.
股價表現：BDTX股票在上週一最後檢查時上漲了2.21％，報4.86美元。
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譯文內容由第三人軟體翻譯。
