Encouraging Data From Seagen/Genmab's Cervical Cancer Study - Tivdak Success Sets Stage For New Indications
Encouraging Data From Seagen/Genmab's Cervical Cancer Study - Tivdak Success Sets Stage For New Indications
Seagen Inc (NASDAQ:SGEN) and Genmab A/S (NASDAQ:GMAB) released topline data from the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received Tivdak (tisotumab vedotin-tftv), compared with chemotherapy alone.
Seagen Inc （納斯達克股票代碼：SGEN）和 Genmab A/S 納斯達克股票代碼：GMAB）發佈了第三期InnovaTV 301全球試驗的頭條數據，該試驗針對的是接受Tivdak（tisotumab vedotin-tftv）且在一線治療中或之後疾病進展的復發或轉移性宮頸癌患者，與單獨使用化療相比。
The study met its primary endpoint of overall survival (OS).
該研究達到了總存活率（OS）的主要終點。
An Independent Data Monitoring Committee determined that OS crossed the pre-specified efficacy boundary at interim analysis.
獨立數據監測委員會在中期分析中確定，OS跨越了預先規定的療效界限。
The key secondary endpoints of investigator-assessed progression-free survival and objective response rate also demonstrated statistical significance.
研究者評估的無進展存活率和客觀反應率的關鍵次要終點也顯示出統計學意義。
The results from innovaTV 301 are intended to serve as the pivotal confirmatory trial for the U.S. accelerated approval and support global regulatory applications for Tivdak.
InnovaTV 301的結果旨在作爲美國加速批准的關鍵確認性試驗，並支持Tivdak的全球監管申請。
The innovaTV 301 China extension study has been initiated and continues to enroll patients in collaboration with Zai Lab Limited (NASDAQ:ZLAB).
InnovaTV 301中國推廣研究已經啓動，並將繼續與以下機構合作招收患者 Zai Lab 有限公司 （納斯達克股票代碼：ZLAB）。
William Blair analyst Matt Phipps says that while the recent news solidifies Tivdak's approved label for second-line recurrent/metastatic cervical cancer, the pivotal question for the future lies in Tivdak's potential expansion into other medical indications.
威廉布萊爾 分析師 Matt Phipps 說，儘管最近的消息鞏固了Tivdak批准的二線復發/轉移性宮頸癌標籤，但未來的關鍵問題在於Tivdak有可能擴展到其他醫學適應症。
The promising data from the innovaTV 207 trial, specifically involving Tivdak as a monotherapy for squamous carcinoma of head and neck cancer patients earlier this year, suggests a strong case for advancing into a pivotal study within this patient group.
今年早些時候，InnovaTV 207試驗特別涉及Tivdak作爲頭頸癌患者鱗狀癌的單一療法，這些數據令人鼓舞，這表明有充分的理由在該患者羣體中推進一項關鍵研究。
Price Action: GMAB shares are up 0.23% at $38.47, and SGEN shares are up 0.89% at $207.91 during the premarket session on the last check Tuesday.
價格走勢： 在週二最後一次支票的盤前交易中，GMAB股價上漲0.23％，至38.47美元，SGEN股價上漲0.89％，至207.91美元。