After Reporting Five Patient Deaths, Data Committee Recommends MacroGenics Halt Prostate Cancer Trial
After Reporting Five Patient Deaths, Data Committee Recommends MacroGenics Halt Prostate Cancer Trial
MacroGenics Inc. (NASDAQ:MGNX) announced on Tuesday that it reviewed data accumulated from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo).
MacroGenics (NASDAQ:MGNX)週二宣佈，已經審查了vobramitamab duocarmazine (vobra duo)的TAMARACk第二階段研究積累的數據。
In May, when the company released interim data from the trial, MacroGenics reported five deaths (fatal outcome) during the trial.
當公司在五月份公佈試驗的中期數據時，Macrogenics報告了五個死亡事件(致命結局)。
After reviewing, MacroGenics agreed with the study's Independent Data Monitoring Committee's recommendation to discontinue the treatment for the remaining metastatic castration-resistant prostate cancer (mCRPC) study participants who could have received additional doses.
經過審核，MacroGenics同意該研究獨立數據監管委員會的建議，停止爲仍可以接受額外劑量的轉移性去勢抵抗前列腺癌（mCRPC）研究參與者提供治療。
Most of these remaining study participants had already received 8-12 cycles of vobra duo. Participants continue to be monitored for adverse events, disease progression and survival.
這些剩餘的研究參與者中，大多數已經接受了8-12個週期的vobra duo治療。參與者將繼續監測不良事件、疾病進展和生存情況。
"We decided to discontinue additional dosing for the remaining TAMARACK participants who had not yet completed treatment. We expect to have the data necessary to determine next steps for the vobra duo program later this year and will provide further updates on an investor call following our ESMO presentation," said Dr. Scott Koenig, president and CEO of MacroGenics.
MacroGenics的總裁兼首席執行官Scott Koenig博士表示："我們決定停止爲還未完成治療的TAMARACk參與者提供額外劑量。我們預計將在今年晚些時候獲得確定vobra duo計劃下一步所需的數據，並將在我們的ESMO報告後的投資者電話會議上提供進一步的更新。"
The company expects to have the mature efficacy findings, including median rPFS, later in the second half of 2024 and plans to present the data at a subsequent medical conference.
該公司預計在2024年下半年公佈成熟的療效發現，包括中位rPFS，並計劃在隨後的醫學會議上呈現這些數據。
The company also announced a poster (display) presentation of clinical data from the TAMARACK Phase 2 study of vobra duo at the upcoming European Society for Medical Oncology (ESMO) Congress 2024.
該公司還宣佈，將在即將到來的2024年歐洲醫學腫瘤學會（ESMO）會議上，展示來自vobra duo的TAMARACk第二階段研究的臨床數據。
The abstract was based on an April 12 data cutoff, and the poster will report additional data from a July 9 data cutoff, including safety, efficacy, and landmark 6-month radiographic progression-free survival (rPFS) data.
文摘以4月12日的數據時止爲基礎，海報將報告7月9日的數據時止，包括安全性、療效和里程碑的6個月放射學進展自由生存（rPFS）數據。
MacroGenics completed enrollment in the TAMARACK study in the fourth quarter of 2023 and plans to present the study's landmark primary endpoint, the 6-month rPFS rate, which represents the proportion of study participants who remain alive and progression-free at six months.
MacroGenics於2023年第四季度完成了TAMARACk研究的招募，並計劃展示該研究的里程碑主要終點——6個月rPFS比率，該比率代表在六個月內仍然健在且沒有進展的研究參與者的比例。
Concurrently, MacroGenics achieved $100 million in milestones from Incyte Corporation (NASDAQ:INCY) related to the development progress of Zynyz (retifanlimabz), following an agreement on July 24. Zynyz is indicated in the U.S. for metastatic or recurrent locally advanced Merkel cell carcinoma.
與此同時，MacroGenics從Incyte Corporation (NASDAQ:INCY)獲得了1億美元的里程碑款項，用於Zynyz (retifanlimabz)的開發進展。這項協議於7月24日達成。Zynyz在美國用於轉移性或複發性局部晚期Merkel細胞癌。
Analyst Reactions:
分析師反應：
- B. Riley Securities downgraded Macrogenics from Buy to Neutral and lowered the price target from $18 to $5.
- Guggenheim downgraded Macrogenics from Buy to Neutral.
- Barclays maintained Macrogenics with an Overweight and lowered the price target from $9 to $8.
- b. Riley Securities將Macrogenics的評級從買入降級爲中立，並將目標價從18美元降至5美元。
- 古根海姆將Macrogenics的評級從買入降級爲中立。
- 巴克萊保持了Macrogenics的超重評級，並將目標價從9美元降至8美元。
MGNX Price Action: MacroGenics stock is down 28.59% at $3.75 at last check Wednesday.
目前爲止，MacroGenics股票下跌了28.59%，報3.75美元。
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Photo: Shutterstock
Photo: shutterstock