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Nanobiotix Establishes Recommended Dose For Registrational Study Of Head & Neck Combo Therapy Trial

Nanobiotix Establishes Recommended Dose For Registrational Study Of Head & Neck Combo Therapy Trial

Nanobiotix确立头颈联合治疗试验注册研究的推荐剂量
Benzinga Real-time News ·  2022/09/22 07:24
  • Nanobiotix (NASDAQ:NBTX) determined the recommended phase 2 dose (RP2D) of the NBTXR3 combo regime for inoperable locoregional recurrent or recurrent and metastatic head and neck squamous cell carcinoma that is resistant to prior immunotherapy.
  • The combo includes NBTXR3 plus Merck & Co Inc's (NYSE:MRK) Keytruda pembrolizumab or Bristol Myers Squibb Co's (NYSE:BMY) Opdivo (nivolumab).
  • The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients.
  • Related: Nanobiotix's Radiotherapy Combo Therapy Shows Boosted Anti-Tumor Activity In Preclinical Studies.
  • The complete dose escalation part enrolled 29 patients in three cohorts. Based on the study's results, the RP2D for all three cohorts was determined to be 33% of gross tumor volume.
  • Nanobiotix has amended the ongoing expansion phase of Study 1100. The amended dose expansion part also has three cohorts. However, the cohorts have been re-designed further to explore NBTXR3 plus anti-PD-1 in several immunotherapy-eligible indications, focusing on patients that are either naïve or resistant to prior immunotherapy.
  • The company expects to provide updated clinical data from Study 1100 in Q4 2022. The registrational phase 3 protocol submission is expected in Q1 2023, followed by modification of the study design.
  • Price Action: NBTX shares closed at $4.04 on Wednesday.
  • 纳米生物纳斯达克(美国国家癌症研究所代码：NBTX)确定了NBTXR3联合方案对先前免疫疗法耐药的无法手术的局部区域复发或复发及转移性头颈部鳞状细胞癌的推荐2期剂量(RP2D)。
  • 组合包括NBTXR3 PLUS默沙东(纽约证券交易所股票代码：MRK)Keytruda pembrolizumab或百时美施贵宝公司(纽约证券交易所代码：BMY)Opdivo(Nivolumab)。
  • 1100号研究的剂量递增和剂量扩大的综合部分预计将纳入多达141名患者。
  • 相关： Nanobiotix的放射治疗联合疗法在临床前研究中显示出增强的抗肿瘤活性.
  • 完全剂量递增部分纳入了三个队列中的29名患者。根据这项研究的结果，所有三个队列的RP2D被确定为大体肿瘤体积的33%。
  • Nanobiotix已经修改了1100号研究的正在进行的扩展阶段。修改后的剂量扩展部分也有三个队列。然而，这些队列已被重新设计，以进一步探索NBTXR3加抗PD-1在几种免疫治疗合格适应症中的应用，重点关注NAÏVE或对先前免疫治疗耐药的患者。
  • 该公司预计将在2022年第四季度提供1100号研究的最新临床数据。注册阶段3方案预计将于2023年第一季度提交，随后将修改研究设计。
  • 价格行动：NBTX股价周三收于4.04美元。
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