Juno Therapeutics, a pioneer in the sizzling field of treating cancer by revving up the immune system, on Thursday said it had halted development of its lead treatment after three patient deaths, dealing a blow to a promising but still unproven approach to oncology called CAR-T immunotherapy.
The treatment, dubbed JCAR015, is created by harvesting a patient’s own immune cells and rewiring them to home in on cancer in the blood. Three patients—all younger than 25—died after excess fluids accumulated in their brains, Juno said.
The first death came in May. Juno Therapeutics, which is based in Seattle, reported it to the Food and Drug Administration. Both the company and federal regulators agreed that it wasn’t clear what caused the death “and a change at that time was not warranted,” Juno CEO Hans Bishop said in a conference call.
But in the last week, two more patients died of the same issue, cerebral edemas.
The FDA then placed the study on clinical hold, meaning no new patients can be enrolled. The trial design called for 90 patients with advanced acute lymphoblastic leukemia to enroll; so far, just 20 have. Those 20 have already received their treatment, as JCAR015, as a one-time infusion.
Therapeutics：/ˌθerə’pjuːtɪks/ n. 治疗学,疗法
sizzling：/’sizliŋ/ adj. 极热的
rev：/rev/ vt. 使加速；增加
halt：/hɔːlt/ vi. 停止；踌躇，犹豫；立定
oncology：/ɒŋ’kɒlədʒɪ/ n. 肿瘤学
immunotherapy：/ˌɪmjʊnəʊ’θerəpɪ/ n. 免疫疗法
dub：vt. [电影]配音；授予称号；轻点；打击 n. 笨蛋；鼓声
warrant：/’wɒr(ə)nt/ n. 授权证; 许可证 vt. 使…显得合理; 成为…的根据
cerebral：/’serɪbr(ə)l/ adj. 大脑的，脑的
edemas：/ɪ’diːmə/ n. 〈美〉水肿，浮肿,瘤腺体
leukemia：/lu:ˈki:mi:ə/ n. <医>白血病(俗称血癌)
infusion：/ɪn’fjuːʒ(ə)n/ n. 灌输；注入物；浸泡；激励