FibroGen Unveils Early Data From Prostate Cancer Candidate, Analyst Advocates Further Exploration In The Landscape
FibroGen Unveils Early Data From Prostate Cancer Candidate, Analyst Advocates Further Exploration In The Landscape
FibroGen Inc (NASDAQ:FGEN) announced topline data from the Fortis Therapeutics-sponsored Phase 1 study of FG-3246 (also known as FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload.
FibroGen Inc（纳斯达克股票代码：FGEN）公布了富通疗法赞助的 FG-3246（也称为 FOR46）1期研究的主要数据，该研究是一种潜在的同类首创抗CD46抗体偶联物（ADC），其有效载荷含有 MMAE。
In a dose-escalation and dose-expansion trial, the study enrolled patients with metastatic castration-resistant prostate cancer whose tumors have progressed on at least one androgen receptor-signaling inhibitor.
在一项剂量递增和剂量扩张试验中，该研究招收了至少一种雄激素受体信号抑制剂后肿瘤进展的转移性去势抵抗性前列腺癌患者。
In the efficacy analysis, prostate-specific antigens (PSA) reductions of over 50% were observed in 36% of PSA evaluable patients.
在疗效分析中，在36％的PSA可评估患者中，观察到前列腺特异性抗原（PSA）减少了50％以上。
20% met the criteria of a partial response, or tumor reduction in size of over 30%, with a median duration of response of 7.5 months. The median radiographic progression-free survival (rPFS) in this heavily pretreated patient population was 8.7 months.
20% 符合部分缓解或肿瘤规模缩小超过 30% 的标准，中位缓解持续时间为7.5个月。在这个经过大量预治疗的患者群体中，放射照相无进展存活率（RPF）的中位数为8.7个月。
The most frequent adverse events were consistent with other MMAE-based ADCs and included infusion-related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy.
最常见的不良事件与其他基于 MMAE 的 ADC 一致，包括输液相关反应、疲劳、体重减轻、中性粒细胞减少和周围神经病变。
William Blair writes that initial FG-3246 results appear to offer numerically improved efficacy metrics relative to alternate novel hormone therapy.
威廉·布莱尔写道，与替代的新型激素疗法相比，最初的 FG-3246 结果似乎提供了数值上的改善疗效指标。
Although the FDA advises against drawing definitive conclusions solely from the point estimate of progression-free survival in single-arm studies, suggesting it be interpreted alongside hazard ratios, William Blair advocates for additional exploration of FG-3246 in prostate cancer due to the study's heavily pretreated participants and inclusion of an unselected population.
尽管美国食品药品管理局建议不要仅根据单组研究中无进展存活率的点估计得出明确结论，建议将其与危害比一起解释，但威廉·布莱尔主张进一步探索 FG-3246 在前列腺癌中的应用，因为该研究的参与者经过了大量的预处理，并且纳入了未选择的人群。
William Blair writes that the company plans to enhance the therapeutic effectiveness of FG-3246 in two key ways:
威廉·布莱尔写道，该公司计划通过两种关键方式提高 FG-3246 的治疗效果：
- Firstly, it will utilize a dosing scheme based on adjusted body weight, inspired by AbbVie Inc's (NYSE:ABBV) approach with Elahere in ovarian cancer treatment.
- Secondly, it will utilize an imaging agent called 89Zr-based CD46 PET to select patients most likely to benefit from FG-3246 in the Phase 2 study.
- 首先，它将采用基于调整后的体重的给药方案，其灵感来自艾伯维公司（纽约证券交易所代码：ABBV）在卵巢癌治疗中使用Elahere的方法。
- 其次，它将使用一种名为基于89ZR的CD46 PET的成像药物来选择最有可能在2期研究中受益于 FG-3246 的患者。
FibroGen management intends to consult with the FDA about the development pathway and commence the Phase 2 study in the latter half of the year.
FibroGen管理层打算就开发路径与美国食品药品管理局协商，并在下半年开始2期研究。
Price Action: FGEN shares are down 18.30% at $1.77 on the last check Wednesday.
价格走势：在周三的最后一次支票中，FGEN股价下跌18.30％，至1.77美元。