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（納斯達克股票代碼：FGEN）公佈了富通療法贊助的 FG-3246（也稱爲 FOR46）1期研究的主要數據，該研究是一種潛在的同類首創抗CD46抗體偶聯物（ADC），其有效載荷含有 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.
在一項劑量遞增和劑量擴張試驗中，該研究招收了至少一種雄激素受體信號抑制劑後腫瘤進展的轉移性去勢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.
在療效分析中，在36％的PSA可評估患者中，觀察到前列腺特異性抗原（PSA）減少了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% 符合部分緩解或腫瘤規模縮小超過 30% 的標準，中位緩解持續時間爲7.5個月。在這個經過大量預治療的患者群體中，放射照相無進展存活率（RPF）的中位數爲8.7個月。
The most frequent adverse events were consistent with other MMAE-based ADCs and included infusion-related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy.
最常見的不良事件與其他基於 MMAE 的 ADC 一致，包括輸液相關反應、疲勞、體重減輕、中性粒細胞減少和周圍神經病變。
William Blair writes that initial FG-3246 results appear to offer numerically improved efficacy metrics relative to alternate novel hormone therapy.
威廉·布萊爾寫道，與替代的新型激素療法相比，最初的 FG-3246 結果似乎提供了數值上的改善療效指標。
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.
儘管美國食品藥品管理局建議不要僅根據單組研究中無進展存活率的點估計得出明確結論，建議將其與危害比一起解釋，但威廉·布萊爾主張進一步探索 FG-3246 在前列腺癌中的應用，因爲該研究的參與者經過了大量的預處理，並且納入了未選擇的人群。
William Blair writes that the company plans to enhance the therapeutic effectiveness of FG-3246 in two key ways:
威廉·布萊爾寫道，該公司計劃通過兩種關鍵方式提高 FG-3246 的治療效果：
- 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，它將採用基於調整後的體重的給藥方案，其靈感來自艾伯維公司（紐約證券交易所代碼：ABBV）在卵巢癌治療中使用Elahere的方法。
- 其次，它將使用一種名爲基於89ZR的CD46 PET的成像藥物來選擇最有可能在2期研究中受益於 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管理層打算就開發路徑與美國食品藥品管理局協商，並在下半年開始2期研究。
Price Action: FGEN shares are down 18.30% at $1.77 on the last check Wednesday.
價格走勢：在週三的最後一次支票中，FGEN股價下跌18.30％，至1.77美元。
譯文內容由第三人軟體翻譯。