新黑色素瘤藥物研制成功 針對BRAF基因突變者
時間：2014-07-21 09:09:30 來源：生物探索 點擊：
制藥巨頭羅氏公司最近宣布與Exelixis公司合作開發(fā)的治療黑色素瘤藥物組合療法在臨床三期研究中達到其預期終點宣告成功。這也為這一產(chǎn)品最終獲得FDA批準掃清了一大障礙。據(jù)了解這種療法是由羅氏公司的Zelboraf和Exelixis公司開發(fā)的xobimetinib結(jié)合而成，能夠針對特定BRAF基因突變患者。使用組合療法的患者生存期等指標都明顯超出了單獨使用Zelboraf的患者。羅氏公司表示公司計劃在未來幾天內(nèi)將這次臨床三期研究的細節(jié)公布出來，并將這種組合療法的上市計劃提上日程。而Exelixis公司則獲得了豐厚的里程碑獎金。
詳細英文報道：
Roche ($RHHBY) and biotech partner Exelixis ($EXEL) said their melanoma-fighting combination therapy met its primary endpoint in Phase III, clearing the way for an FDA application and giving the latter company a boost in its share value.
In a study on 495 patients with a certain mutation of the BRAF gene, a combination of the Exelixis-discovered cobimetinib and Roche's on-the-market Zelboraf helped subjects live significantly longer without disease progression than those treated with Zelboraf alone. The study, called coBRIM, hit its primary goal of progression-free survival, all with a safety profile in keeping with previous studies of the combination, Roche said.
The partners are disclosing only top-line results for now, planning to divulge full details at a future scientific meeting. In the meantime, Roche said it now has the data it needs to support an application with the FDA and other global regulators, though the company has yet to specify a timeline for submissions.
"Despite great progress in our understanding and therapy in recent years, advanced melanoma remains a difficult and deadly disease that requires more treatment options," Chief Medical Officer Dr. Sandra Horning said in a statement. "These encouraging data support the potential combined use of cobimetinib with Zelboraf to block tumor growth longer than Zelboraf alone. We hope this combination therapy will lead to a new option for patients."
As for Exelixis, the Phase III success sent the biotech's shares up about 11% in premarket trading on Monday. And the South San Francisco-headquartered company is expecting three more late-stage data readouts this year, CEO Michael Morrissey said, with results due on studies of the proprietary cabozantinib on prostate, thyroid and renal cancers.
Exelixis discovered cobimetinib in-house and advanced it to the IND stage before signing a deal with Roche's Genentech, reaping $40 million up front with the chance to pocket more milestones down the line. The drug, which targets BRAF V600 mutation-positive melanoma, works by shutting down the kinase MEK, a pathway that regulates growth factor receptors and plays a hand in helping tumors proliferate.
