Darzalex能否成为多发性骨髓瘤治疗的亮点?

https://www.firstwordpharma.com/node/1391602

近些年,多发性骨髓瘤上市了新药硼替佐米和来那度胺,让医生有了更多选择,同时不断有新的临床研究数据出现,让医生选择最优方案也犯了难。不过,来那度胺加地塞米松还是基础。杨森的Darzalex (daratumumab)准备抢风头了。本届EHA大会上杨森的Darzalex (daratumumab)的三期临床研究(CASTOR)显示在三线治疗,Darzalex加硼替佐米加地塞米松比硼替佐米加地塞米松,减少疾病进展或死亡风险百分之61。这方案也够贵,好像杨森喜欢整豪华方案,如硼替佐米加脂质体阿霉素等。

原文如下

KOL Views: How and how quickly might Darzalex move upstream in multiple myeloma practice patterns – and what may stand in its way?

(Ref: KOL Views Desk) June 14th, 2016 By: Michael Flanagan

New drugs for multiple myeloma (MM) have been coming to market left and right over the past few years, adding new layers of complexity to established practice patterns. A good problem to have, to be sure, but the steady flow of clinical data has made the task of ensuring optimal treatment for patients all the more difficult for physicians.

Despite recent changes, one thing that has remained consistent has been the use of Celgene’s Revlimid (lenalidomide) plus dexamethasone as the backbone of the increasingly complicated combinations that have become commonplace in MM.

Darzalex (daratumumab) from Johnson & Johnson and Genmab is one of the fresh combatants in the MM arena, though like other new agents it has been relegated largely to use as part of in later-line therapy. That may soon change, however, based on a pair of readouts presented at this month’s annual ASCO meeting.

Specifically, data from the Phase III CASTOR trial showed Darzalex reduced the risk of disease progression or death by 61 percent when added to Velcade (bortezomib) and dexamethasone versus the doublet in third-line patients. In addition, data from the Phase III POLLUX trial showed the anti-CD38 mAb reduced the risk of disease progression or death by 63 percent when added to Revlimid plus dexamethasone versus the doublet in second-line patients. (See ViewPoints: Darzalex hits second home run, but experts cautious on pricing of combination therapies in myeloma.)

The readouts are likely to pave the way for Darzalex to move rapidly upstream into earlier lines of therapy for MM, though the complex and ever-evolving nature of the treatment algorithm raises a lot of questions.

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