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Nanobiotix Announced New Data At ASCO 2924, Showing 48% ORR In Evaluable Anti-PD-1 Naïve Patients (N=25); 28% ORR In Evaluable Anti-PD-1 Resistant Patients (N=25) As Per RECIST 1.1

Nanobiotix Announced New Data At ASCO 2924, Showing 48% ORR In Evaluable Anti-PD-1 Naïve Patients (N=25); 28% ORR In Evaluable Anti-PD-1 Resistant Patients (N=25) As Per RECIST 1.1

Nanobiotix在ASCO 2924上公佈了新數據,顯示可評估的抗PD-1新生患者(N=25)的ORR爲48%;根據RECIST 1.1,可評估的抗PD-1耐藥患者(N=25)的ORR爲28%
Benzinga ·  06/02 22:42

NANOBIOTIX (NASDAQ:NBTX) today announced new data from Study 1100, a US Phase 1 dose escalation and dose expansion study evaluating radiotherapy-activated NBTXR3 followed by anti-PD-1 immune checkpoint inhibitors ("ICIs") as a second-or-later line ("2L+") therapy for patients with advanced solid and metastatic tumors. These data were presented by Study 1100 Coordinating Investigator Colette Shen, MD, PhD, at the 2024 Annual Meeting of the American Society for Clinical Oncology ("ASCO 2024").

nanobiotix(納斯達克:NBTX)今天宣佈了來自1100研究的新數據,這是一項美國1期劑量逐步升高及擴大劑量的研究,評估放射治療活化的NBTXR3,隨後使用抗PD-1免疫檢查點抑制劑(“ICI”)作爲晚期實體腫瘤和轉移性腫瘤1-2線(“2L +”)治療的患者。這些數據是由1100研究協調的調查員Colette Shen博士在2024年美國臨床腫瘤學會(“ASCO 2024”)年會上介紹的。

  • Data show favorable safety and feasibility in 68 heavily pre-treated patients with R/M-HNSCC (Intention-to-Treat population; "ITT") who received RT-activated NBTXR3 followed by anti-PD-1 as a second-or-later line treatment
  • 48% ORR in evaluable anti-PD-1 naïve patients (n=25); 28% ORR in evaluable anti-PD-1 resistant patients (n=25) as per RECIST 1.1
  • 76% DCR in evaluable naïve patients; 68% DCR in evaluable resistant patients as per RECIST 1.1
  • Preliminary review of survival data in ITT anti-PD-1 naïve patients (n=33) showed mPFS of 7.3 months and mOS of 26.2 months
  • ITT anti-PD-1 resistant patients (n=35) showed mPFS of 4.2 months and mOS of 7.8 months
  • Following the ASCO presentation, Nanobiotix will host an investor event on Sunday, June 2nd at 12:00 PM EDT / 6:00 PM CEST to review the presented results
  • 數據顯示,在接受RT激活的NBTXR3後,68名經過重度預處理的R/M-HNSCC(意圖治療群體;“ITT”)患者中,接受抗PD-1作爲第二或更後期線治療的有效性和可行性良好。
  • 根據RECIST 1.1,抗PD-1 naïve患者(n = 25)的評估可行性爲48%ORR;抗PD-1耐藥患者(n = 25)的評估可行性爲28%ORR。
  • 根據RECIST 1.1,接受評估的抗PD-1純種患者中,76%的naïve患者具有疾病控制率(DCR);可耐受的患者中有68%的DCR。
  • 在意圖治療Anti-PD-1 naïve患者中初步評估的生存狀況數據(n = 33)顯示,mPFS爲7.3個月,mOS爲26.2個月。
  • 意圖治療Anti-PD-1耐藥患者(n = 35)顯示,mPFS爲4.2個月,mOS爲7.8個月。
  • 在ASCO展示後,nanobiotix將於美國東部時間6月2日星期日下午12:00 /中歐夏令時晚上6:00舉行投資者活動,以回顧展示的結果。

譯文內容由第三人軟體翻譯。


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