新疗法显现！花400万，就能治愈晚期癌症？
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q2.itc.cn/q_70/images03/20240405/f262f9e4b8ef42d3aea4984ba4e67c6f.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">即便被冠以抗癌神药之<span style="color: black;">叫作</span>，CAR-T疗法并不完美。即便给血液肿瘤带来了“治愈”<span style="color: black;">期盼</span>，但在占比高达90%的实体瘤中，CAR-T疗法<span style="color: black;">始终</span><span style="color: black;">无</span>突破性的<span style="color: black;">发展</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">近期</span>“后来者”TIL（肿瘤浸润淋巴细胞）疗法的<span style="color: black;">显现</span>，有望率先打破这一僵局。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">01</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">耗时40年的突破</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">在很长一段时间，<span style="color: black;">咱们</span><span style="color: black;">针对</span><span style="color: black;">疾患</span>和<span style="color: black;">药品</span>的认知，是一个非常简单的模型。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">便是</span>我<span style="color: black;">患病</span>了，我吃药，<span style="color: black;">药品</span>将我<span style="color: black;">身体</span>的微生物给清除，我的病就好了</span></strong><span style="color: black;">。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">专家</span>们和<span style="color: black;">大夫</span><span style="color: black;">期盼</span><span style="color: black;">经过</span><span style="color: black;">这般</span>的理论来治疗癌症</span></strong><span style="color: black;">，将癌细胞和微生物等同起来，用<span style="color: black;">各样</span>办法<span style="color: black;">例如</span>说化疗、放疗、靶向治疗，彻底消灭癌细胞，癌症就能痊愈。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q3.itc.cn/q_70/images03/20240405/a050af02d5f14cc28a90e80e19ae1f5d.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">◎</span><span style="color: black;">图：123rf</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">然则</span>现实显然<span style="color: black;">无</span><span style="color: black;">那样</span>简单。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">由于</span><span style="color: black;">此刻</span>治疗癌症，是“杀敌一千自损八百”的<span style="color: black;">办法</span>。<strong style="color: blue;">现有的治疗手段<span style="color: black;">没</span>法精确到只打击癌细胞。</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">如今科学界有了<span style="color: black;">有些</span>观念的转变，<span style="color: black;">大众</span>就想肿瘤细胞<span style="color: black;">亦</span>不是生长在真空中的，肿瘤细胞本质上<span style="color: black;">亦</span>是生长在人<span style="color: black;">身体</span>，<strong style="color: blue;"><span style="color: black;">为何</span><span style="color: black;">不可</span>利用人体正常的抵御机制——免疫机制来杀死这些癌细胞呢？</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;">/这个观念的转变，<span style="color: black;">促进</span>了免疫治疗的诞生/</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">PD-1/L1开启了肿瘤免疫疗法的新时代，随即CAR-T疗法又将免疫疗法<span style="color: black;">说到</span>了新的高度，此次TIL疗法<span style="color: black;">最终</span><span style="color: black;">获准</span>，让<span style="color: black;">大夫</span>们惊呼<strong style="color: blue;">癌症的“洪水”<span style="color: black;">最终</span>撞到了更高的“堤坝”</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">TIL疗法全<span style="color: black;">叫作</span>叫做肿瘤浸润淋巴细胞疗法。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">肿瘤浸润淋巴细胞是一种存在于肿瘤微环境中的免疫细胞，<strong style="color: blue;">它的<span style="color: black;">重点</span><span style="color: black;">功效</span><span style="color: black;">便是</span>识别身<span style="color: black;">身体</span>的癌细胞，并进行消灭</strong>，但不<span style="color: black;">晓得</span>什么<span style="color: black;">原由</span>在癌症<span style="color: black;">病人</span>中，这类细胞数量忽然变得<span style="color: black;">稀疏</span>或者活性降低，才<span style="color: black;">最后</span><span style="color: black;">引起</span>了癌症的<span style="color: black;">出现</span>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q0.itc.cn/q_70/images03/20240405/777f00b902f94f649bb76a21d12f1b5d.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">◎ </span><span style="color: black;">TIL细胞疗法的流程示意图。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;"><span style="color: black;"><span style="color: black;">怎样</span>在体外制造<span style="color: black;">拥有</span>抗肿瘤活性的肿瘤浸润淋巴细胞，<span style="color: black;">作为</span>该细胞疗法的<span style="color: black;">重要</span>。</span></strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;"><span style="color: black;">/与其师出“同门”的CAR-T疗法相比，TIL治疗更受瞩目，<span style="color: black;">为何</span>？/</span></strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">虽然TIL和CAR-T疗法都是利用从<span style="color: black;">病人</span><span style="color: black;">身体</span><span style="color: black;">得到</span>的免疫细胞来治疗癌症，但两者却有着截然不同的“出生”，<strong style="color: blue;">CAR-T免疫细胞来自<span style="color: black;">病人</span>血液，而TIL免疫细胞来自<span style="color: black;">病人</span>肿瘤组织</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">这就决定了两者识别肿瘤的能力，肿瘤组织分离的免疫细胞，超60%能识别肿瘤，而血液分离的免疫细胞，仅有<span style="color: black;">少于</span>等于0.5%。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">有行业分析认为，<strong style="color: blue;">TIL疗法<span style="color: black;">处理</span>了CAR-T乃至其他细胞疗法难以彻底<span style="color: black;">处理</span>的实体瘤<span style="color: black;">困难</span></strong>，以“<span style="color: black;">无</span>特定靶点”的手段<span style="color: black;">回复</span>了“缺乏靶点”的问题，以“来自肿瘤微环境”克服“肿瘤微环境限制”。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q0.itc.cn/q_70/images03/20240405/2d5deb7193ba4bd08af313e7b812eb2f.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">◎ </span><span style="color: black;"><span style="color: black;">全世界</span>免疫细胞临床<span style="color: black;">科研</span>数量（<span style="color: black;">截止</span> 2019 年 2 月）</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">02</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">晚期的恶性肿瘤<span style="color: black;">亦</span>能被治愈</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">细胞疗法<span style="color: black;">最终</span>在实体瘤这块硬骨头上狠狠啃下了一口。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">首个用于实体瘤的TIL疗法<span style="color: black;">制品</span>——Amtagvi（lifileucel）此次<span style="color: black;">获准</span><strong style="color: blue;">先用于晚期黑色素瘤治疗</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">按照</span>FDA<span style="color: black;">颁布</span>的信息，在符合<span style="color: black;">前提</span>的73例晚期黑色素瘤<span style="color: black;">病人</span>中，<strong style="color: blue;">有31.5%<span style="color: black;">运用</span>后病情得到缓解，其中3例肿瘤消失</strong>，20例肿瘤减小。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">对治疗有反应的<span style="color: black;">病人</span>中，<strong style="color: blue;">有43.5%的<span style="color: black;">病人</span><span style="color: black;">最少</span>在12个月内保持住了治疗的成果</strong>，肿瘤<span style="color: black;">无</span>恶化，<span style="color: black;">病人</span><span style="color: black;">亦</span><span style="color: black;">无</span>死亡。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q0.itc.cn/q_70/images03/20240405/b6cfa95ae7b84e27af34ec64b369fbb8.png" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">◎ </span><span style="color: black;">首个用于实体瘤的TIL疗法<span style="color: black;">制品</span>——Amtagvi（lifileucel）</span><span style="color: black;">/</span><span style="color: black;">图：Iovance Biotherapeutics官网</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">仅从数字看，30%多的有效率似乎并不高，<span style="color: black;">然则</span>在<span style="color: black;">无</span>太多好的治疗<span style="color: black;">办法</span>的黑色素瘤<span style="color: black;">行业</span>就不同了，<strong style="color: blue;"><span style="color: black;">这里</span>之前，一线主流<span style="color: black;">药品</span>治疗的总体缓解率<span style="color: black;">亦</span><span style="color: black;">仅有</span>20%<span style="color: black;">上下</span></strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">值得<span style="color: black;">重视</span>的是，这次纳入<span style="color: black;">科研</span>的<span style="color: black;">病人</span>都经过了多种治疗<span style="color: black;">办法</span>，面临<span style="color: black;">没</span>药可救的晚期黑色素瘤病人，<span style="color: black;">通常</span>生命只剩下<span style="color: black;">7、</span>八个月，<strong style="color: blue;">能有<span style="color: black;">这般</span>的治疗效果，<span style="color: black;">已然</span>是绝处逢生了</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">况且</span>，有的<span style="color: black;">病人</span>治疗效果<span style="color: black;">已然</span>保持了4年多。业界认为，这说明Amtagvi的<span style="color: black;">功效</span>效果<span style="color: black;">连续</span>时间较长，<span style="color: black;">亦</span>是该药的<span style="color: black;">优良</span>之一。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">除此之外，TIL疗法针对非<strong style="color: blue;">小细胞肺癌、卵巢癌、头颈癌、宫颈癌等</strong>都在同步进行临床<span style="color: black;">实验</span>，从已知的信息来看，<span style="color: black;">日前</span>TIL疗法针对在PD-1耐药后的非小细胞肺癌<span style="color: black;">病人</span>中<strong style="color: blue;">取得了很好的效果</strong>，值得期待。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">这些结果纷纷指向一个事实，<strong style="color: blue;"><span style="color: black;">便是</span><span style="color: black;">运用</span>这类疗法有可能在实体瘤（<span style="color: black;">日前</span>是黑色素瘤）<span style="color: black;">行业</span>续写“艾米丽式”的奇迹</strong>（艾米丽患上了白血病，<span style="color: black;">运用</span>了CART治疗后，<span style="color: black;">专家</span>们惊讶<span style="color: black;">发掘</span>之前的癌细胞消失了，真正<span style="color: black;">叫作</span>得上治愈了白血病）。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q6.itc.cn/q_70/images03/20240405/991111d8a1dd4c158cb94d7d93219f21.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">◎ </span><span style="color: black;">图：123rf</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">03</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><strong style="color: blue;">谁能为<span style="color: black;">昂贵</span>的免疫治疗<span style="color: black;">花费</span>买单？</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">肿瘤免疫细胞疗法在CART疗法<span style="color: black;">显现</span>后，<strong style="color: blue;">给人最直观的感觉<span style="color: black;">便是</span>贵</strong>，以国内上市的CAR-T<span style="color: black;">药品</span>阿基仑赛注射液和瑞基奥仑赛注射液为例，<strong style="color: blue;">一针高达120万元</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">而TIL疗法<span style="color: black;">花费</span>更甚，39深<span style="color: black;">呼气</span><span style="color: black;">认识</span>到，<strong style="color: blue;"><span style="color: black;">日前</span>采用TIL疗法的前提，<span style="color: black;">必须</span><span style="color: black;">病人</span><span style="color: black;">首要</span>进行肿瘤切除手术</strong>，换言之，<span style="color: black;">运用</span> TIL疗法治疗<span style="color: black;">需求</span><span style="color: black;">必要</span>是可以切除的肿瘤，并且在切除样本中要<span style="color: black;">得到</span>足量的TIL。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">在<span style="color: black;">经过</span>手术<span style="color: black;">得到</span><span style="color: black;">拥有</span>足量TIL的活性样本后，<span style="color: black;">必须</span>经历大约34天的制备流程。<span style="color: black;">病人</span>还<span style="color: black;">必须</span><span style="color: black;">经过</span>淋巴细胞清除预处理，再重新输注TIL。<span style="color: black;">同期</span><span style="color: black;">病人</span>还<span style="color: black;">必须</span><span style="color: black;">连续</span>注射大剂量的IL-2以继续保持细胞活性，但大剂量的IL-2本身就<span style="color: black;">拥有</span>生物毒性。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q5.itc.cn/q_70/images03/20240405/ef63a184bb8445ea9d58ee7159796445.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">◎ </span><span style="color: black;">图：123rf</span></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">据<span style="color: black;">认识</span>，<strong style="color: blue;"><span style="color: black;">日前</span>上市的Amtagvi定价为51.5万美元（370万人民币）</strong>，并且不<span style="color: black;">包括</span>IL-2的<span style="color: black;">花费</span>，而IL-2是<span style="color: black;">必要</span>与TIL疗法<span style="color: black;">同期</span><span style="color: black;">运用</span>的<span style="color: black;">要紧</span>一环，一次剂量的IL-2<span style="color: black;">花费</span>是5855美元（4万人民币）。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">亦</span><span style="color: black;">便是</span>说，<strong style="color: blue;">总的TIL疗法+ IL-2的<span style="color: black;">花费</span>大约<span style="color: black;">必须</span>人民币374万元<span style="color: black;">上下</span></strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">倘若</span><span style="color: black;">无</span>医疗保险和国家层面的政策扶持，这一疗法远非普通人<span style="color: black;">能够</span>尝试。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;"><span style="color: black;">另外</span>TIL还有<span style="color: black;">有些</span>独特的问题<span style="color: black;">必须</span><span style="color: black;">处理</span>。<span style="color: black;">例如</span>肿瘤内部<span style="color: black;">必要</span>要有免疫细胞存在，其次在进行TIL治疗前要进行大剂量的化疗，<strong style="color: blue;"><span style="color: black;">病人</span>身体<span style="color: black;">是不是</span>能够负荷<span style="color: black;">亦</span>充满未知数</strong>。“TIL疗法是一种新疗法、一种新<span style="color: black;">期盼</span>，<span style="color: black;">然则</span>生产工艺<span style="color: black;">繁杂</span>，价格太高了，<span style="color: black;">将来</span>可及性低。”医药行业资深人士说。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="https://q1.itc.cn/q_70/images03/20240405/b5353e5457a947fc8e6052217e6f3dc6.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">◎ </span><span style="color: black;"><span style="color: black;">TIL疗法<span style="color: black;">必须</span><span style="color: black;">昂贵</span>的<span style="color: black;">花费</span>。/</span></span><span style="color: black;">图：锐景视觉</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">但<span style="color: black;">日前</span>，治愈的<span style="color: black;">期盼</span>已被点燃，守住抗癌的最后防线，让<span style="color: black;">更加多</span>药企愿意投入<span style="color: black;">开发</span>。据39深<span style="color: black;">呼气</span><span style="color: black;">认识</span>，<strong style="color: blue;">在中国，就<span style="color: black;">最少</span>有14家药企在<span style="color: black;">研发</span>实体瘤的TIL疗法。</strong></span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">但<span style="color: black;">针对</span><span style="color: black;">更加多</span>的专家而言，<strong style="color: blue;">癌症的任何治疗方式远不如<span style="color: black;">初期</span>预防来的有效</strong>。</span></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><span style="color: black;">寄<span style="color: black;">期盼</span>于靠<span style="color: black;">药品</span>治愈癌症，肿瘤专家们说，<span style="color: black;">初期</span><span style="color: black;">发掘</span>，早诊断更经济划算。</span></p>
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