百时美施贵宝公司报告称，在其针对自身免疫性疾病的实验性细胞疗法临床试验中发生一例死亡病例，这可能会加剧人们对这一极具前景的新型疗法安全性的担忧。文/麦迪逊·穆勒 百时美施贵宝公司该公司周五表示，一名接受其多发性硬化症疗法治疗的患者死于败血性肺炎，此前诺华公司另一项独立项目中已发生三例死亡病例。
Bristol Myers Squibb Co. has reported a death in its clinical trials of an experimental cell therapy for autoimmune diseases, potentially adding to safety concerns about a promising new class of treatments. By Madison Muller Bristol Myers Squibb Co.
诺华的死亡病例涉及不同的并发症，给将CAR-T疗法从癌症治疗扩展到狼疮和多发性硬化症等慢性疾病的努力蒙上了阴影。虽然这些疗法显示出单次输注后产生长期缓解的潜力，但也可能引发危险的免疫反应。
The company said Friday that a patient receiving its therapy for multiple sclerosis died from septic pneumonia following three deaths in a separate program run by Novartis AG The Novartis fatalities, which involved different complications, have cast a shadow over efforts to expand CAR-T therapies beyond cancer and into chronic conditions such as lupus and multiple sclerosis. While the therapies have shown the potential to produce long-lasting remissions after a single infusion, they can also trigger dangerous immune responses.
百时美施贵宝股价在纽约早盘交易中下跌近2%。其股价今年迄今上涨约15%。
Bristol Myers stock dropped nearly 2% in New York morning trading. Its shares are up roughly 15% this year.
该公司一直在测试其名为“佐拉-赛尔”的疗法，用于包括多发性硬化症在内的多种疾病。最新一例死亡发生在针对多发性硬化症的早期临床试验中，多发性硬化症是一种影响神经系统的慢性自身免疫性疾病。
The company has been testing its treatment, known as zola-cel, in conditions including multiple sclerosis. The latest death occurred in an early-stage trial for MS, a chronic autoimmune disease that affects the nervous system.
布里斯托尔表示，该患者在接受治疗44天后死亡。患者出现了对初始治疗无反应的神经系统症状，促使医生给予一种抑制免疫系统的化疗药物。随后患者出现脓毒性肺炎，并于次日死亡。
The patient died 44 days after receiving treatment, Bristol said. They had developed neurological symptoms that didn’t respond to initial treatments, prompting doctors to administer a chemotherapy drug that suppresses the immune system. The patient then developed septic pneumonia and died the following day.
在其早期自身免疫性疾病临床试验中，包括190名接受第一期研究治疗的人在内，未发生其他死亡病例。
No other deaths occurred among patients treated across its early-stage autoimmune disease trials, including 190 people treated in Phase 1 studies.
此次披露发生在百时美施贵宝因炎症性副作用报告而自愿暂停其自身免疫性CAR-T疗法临床试验入组之后。目前尚未公布试验恢复的任何公告。诺华则在三人死亡事件后单独暂停了多项研究。
The disclosure comes after Bristol Myers voluntarily paused enrollment in its autoimmune CAR-T trials following reports of inflammatory side effects. No announcements have been made about the resumption of the trials. Novartis separately suspended several studies after the three deaths.
尽管存在安全担忧，布里斯托尔表示，所有接受较高剂量佐拉-赛尔（zola-cel）的60名患者在最近一次随访时均未服用常规多发性硬化症药物，其中包括九名接受监测超过一年的患者。大多数有足够随访时间的患者未出现新的疾病活动或残疾加重。
Despite safety concerns, Bristol said all 60 patients who received the higher dose of zola-cel remained off conventional multiple sclerosis medications at their latest follow-up, including nine who had been monitored for more than a year. Most patients with sufficient follow-up showed no new disease activity or worsening disability.