Iovance Biotherapeutics has never taken a straight path from A to B when it comes to developing its tumor-infiltrating lymphocyte (TIL) therapies. But this time, the California biotech seems to have found a solution that could mean an accelerated nod for a lung cancer medicine.

Iovance Biotherapeutics在开发其肿瘤浸润淋巴细胞（TIL）疗法时从未采取过从a到B的直线路径。但这次，加利福尼亚生物技术公司似乎找到了一种解决方案，可能意味着肺癌药物的加速点头。

Iovance reported a positive outcome from a type B pre-phase 3 meeting with the FDA, according to a July 10 press release. The agency has indicated that data from the ongoing registrational single-arm phase 2 IOV-LUN-202 trial “may be acceptable” to secure an accelerated approval for the med, called LN-145.

根据7月10日的新闻稿，Iovance报告了与FDA举行的B型前3期会议的积极成果。该机构表示，正在进行的注册单臂2期IOV-LUN-202试验“可能是可以接受的”数据，以确保加速批准med，称为LN-145。

The therapy is in the midstage trial for advanced, difficult-to-treat non-small cell lung cancer (NSCLC)..

该疗法正处于晚期，难以治疗的非小细胞肺癌（NSCLC）的中期试验中。。

With the door opened for a swift review, Iovance took a cut of the available data, which included a preliminary analysis of 23 patients who received LN-145. The early results show a 26.1% objective response rate, or one complete and five partial responses, plus a disease control rate of 82.6%, Iovance said.

随着迅速审查的大门打开，Iovance切断了现有的数据，其中包括对23名接受LN-145的患者的初步分析。Iovance说，早期结果显示客观缓解率为26.1%，或一项完全缓解和五项部分缓解，疾病控制率为82.6%。

The median duration of response has not yet been reached, however, rates of 1.4-plus months to 9.7-plus months were observed..

尚未达到中位反应持续时间，但是，观察到的比率为1.4个月至9.7个月以上。。

Iovance will now move to enroll about 120 patients into the registrational study, a process that is expected to complete in the second half of 2024.

Iovance现在将招收约120名患者参加注册研究，这一过程预计将在2024年下半年完成。

Later this year, Iovance will meet again with the FDA to discuss a randomized confirmatory trial for LN-145 in NSCLC for front-line advanced patients. The confirmatory trial is expected to be underway by the time a potential accelerated approval comes through, according to the company. This is key, as the FDA has tightened its requirements for offering accelerated approvals in the past year.

今年晚些时候，Iovance将再次与FDA会面，讨论LN-145在NSCLC中用于一线晚期患者的随机确认试验。据该公司称，在潜在的加速批准通过之前，预计验证性试验将正在进行中。这是关键，因为FDA在过去一年收紧了提供加速批准的要求。

The agency now prefers to see a confirmatory trial underway by the time a regulatory nod is offered..

该机构现在更愿意在提供监管点头时看到正在进行的确认性试验。。

The regulatory clarity is good news for Iovance, which has never navigated a straight path for its therapies. In May 2022, the company’s melanoma data for TIL candidate lifileucel disappointed investors when the fresh data cut did not match up favorably to a previous readout.

监管的清晰度对Iovance来说是个好消息，Iovance从未为其治疗开辟过一条直线。2022年5月，当新数据削减与之前的读数不匹配时，该公司针对TIL候选人lifileucel的黑色素瘤数据让投资者失望。

A few months before that, the same drug was debated at the FDA when the agency asked for more assay data. Providing an update on that process today, Iovance said the biologics license application “remains on track” under priority review in advanced melanoma. The due date for a decision is Nov. 25, 2023.

在此之前的几个月，当该机构要求提供更多的检测数据时，同样的药物在FDA上进行了辩论。今天提供有关该过程的最新信息，Iovance表示，在晚期黑色素瘤的优先审查中，生物制剂许可申请“保持正常”。决定的截止日期是2023年11月25日。

Iovance had previously hoped for a 2022 launch..

Iovance以前曾希望2022年发射。。

Iovance’s shares gained nearly 12% to $8.10 as the markets opened July 10 compared to a previous close of $7.24.

随着市场于7月10日开放，Iovance的股票上涨近12%至8.10美元，而此前的下跌为7.24美元。