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)周二宣布，已经审查了vobramitamab duocarmazine (vobra duo)的TAMARACk第二阶段研究积累的数据。
In May, when the company released interim data from the trial, MacroGenics reported five deaths (fatal outcome) during the trial.
当公司在五月份公布试验的中期数据时，Macrogenics报告了五个死亡事件(致命结局)。
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.
经过审核，MacroGenics同意该研究独立数据监管委员会的建议，停止为仍可以接受额外剂量的转移性去势抵抗前列腺癌（mCRPC）研究参与者提供治疗。
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.
这些剩余的研究参与者中，大多数已经接受了8-12个周期的vobra duo治疗。参与者将继续监测不良事件、疾病进展和生存情况。
"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的总裁兼首席执行官Scott Koenig博士表示："我们决定停止为还未完成治疗的TAMARACk参与者提供额外剂量。我们预计将在今年晚些时候获得确定vobra duo计划下一步所需的数据，并将在我们的ESMO报告后的投资者电话会议上提供进一步的更新。"
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.
该公司预计在2024年下半年公布成熟的疗效发现，包括中位rPFS，并计划在随后的医学会议上呈现这些数据。
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.
该公司还宣布，将在即将到来的2024年欧洲医学肿瘤学会（ESMO）会议上，展示来自vobra duo的TAMARACk第二阶段研究的临床数据。
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日的数据时止为基础，海报将报告7月9日的数据时止，包括安全性、疗效和里程碑的6个月放射学进展自由生存（rPFS）数据。
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于2023年第四季度完成了TAMARACk研究的招募，并计划展示该研究的里程碑主要终点——6个月rPFS比率，该比率代表在六个月内仍然健在且没有进展的研究参与者的比例。
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.
与此同时，MacroGenics从Incyte Corporation (NASDAQ:INCY)获得了1亿美元的里程碑款项，用于Zynyz (retifanlimabz)的开发进展。这项协议于7月24日达成。Zynyz在美国用于转移性或复发性局部晚期Merkel细胞癌。
Analyst Reactions:
分析师反应：
- 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将Macrogenics的评级从买入降级为中立，并将目标价从18美元降至5美元。
- 古根海姆将Macrogenics的评级从买入降级为中立。
- 巴克莱保持了Macrogenics的超重评级，并将目标价从9美元降至8美元。
MGNX Price Action: MacroGenics stock is down 28.59% at $3.75 at last check Wednesday.
目前为止，MacroGenics股票下跌了28.59%，报3.75美元。
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Photo: Shutterstock
Photo: shutterstock