Grandbrothers/iStock Editorial via Getty Images Shares of Iovance Biotherapeutics (NASDAQ:IOVA) gained 8% premarket on Monday after it said that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on a Phase 2 study evaluating its experimental lung cancer cell therapy, LN-145.

Grandbrothers/iStock通过Getty Images发表社论Iovance Biotherapeutics（纳斯达克：IOVA）的股票周一上市前上涨8%，此前该公司表示，美国食品和药物管理局（FDA）解除了对其实验性肺癌细胞治疗LN-145的2期研究的部分临床搁置。

Back in December, the U.S. drug regulator placed Iovance’s (IOVA) Phase 2 IOV-LUN-202 trial for LN-145 on clinical hold following the death of a trial participant. The study was designed to evaluate LN-145, a tumor-infiltrating lymphocyte (TIL) therapy, as a late-line option for certain patients with non-small cell lung cancer (NSCLC).

早在12月，美国药物监管机构在一名试验参与者死亡后，将Iovance（IOVA）针对LN-145的第二阶段IOV-LUN-202试验置于临床搁置状态。该研究旨在评估LN-145（一种肿瘤浸润淋巴细胞（TIL）疗法）作为某些非小细胞肺癌（NSCLC）患者的晚期选择。

Since then, the biotechnology company has worked with the FDA and an independent data monitoring committee to develop additional safety measures and monitoring. Upon reviewing this proposal, the FDA has cleared Iovance (IOVA) to resume patient enrollment in IOV-LUN-202. .

从那时起，该生物技术公司与FDA和一个独立的数据监测委员会合作，制定额外的安全措施和监测。在审查该提案后，FDA已批准Iovance（IOVA）恢复IOV-LUN-202中的患者登记。

Iovance (IOVA) expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025. Preliminary data from the IOV-LUN-202 trial supported the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies.

Iovance（IOVA）预计在2025年完成IOV-LUN-202登记队列中约120名患者的登记。来自IOV-LUN-202试验的初步数据支持一次性TIL治疗的潜在益处，包括比可用的二线化疗更持久的反应的机会。

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