An antibody-drug conjugate (ADC) that GSK licensed from China's Hansoh Pharma in a $1.7 billion deal last year has been given breakthrough status by the FDA.The coveted designation for GSK5764227 (GSK'227, previously known as HS-20093) is for the use of the ADC to treat relapsed or refractory extensive-stage small-cell lung cancer (SCLC) and comes after 'promising early clinical evidence' in this tumour type, according to the pharma group.B7-H3, also known as CD276, is an immunoregulatory protein that is overexpressed in tumour tissue, notably in lung, breast, ovarian, gastric, and brain cancer as well as squamous cell carcinoma of the skin.

葛兰素史克（GSK）去年以17亿美元的价格从中国汉寿制药（Hansoh Pharma）获得许可的抗体-药物偶联物（ADC）已被FDA授予突破性地位。GSK5764227（GSK'227，以前称为HS-20093）令人垂涎的名称是用于使用ADC治疗复发或难治性广泛期小细胞肺癌（SCLC），并且是在这种肿瘤类型的“有希望的早期临床证据”之后出现的，据pharma group称。B7-H3，也称为CD276，是一种免疫调节蛋白，在肿瘤组织中过表达，特别是在肺癌，乳腺癌，卵巢癌，胃癌和脑癌以及皮肤鳞状细胞癌中。

It has limited expression in normal tissues, making it an interesting target for therapy that could avoid off-target side effects.'Extensive-stage small-cell lung cancer is aggressive with poor prognosis and significant need for new treatments,' said Hesham Abdullah, global head of oncology, R&D at GSK.Phase 1 data presented at last year's ASCO congress revealed that 34 out of 40 (85%) heavily pre-treated patients with SCLC, non-small cell lung cancer (NSCLC), and sarcoma saw evidence of disease control, with 14 partial responses.

它在正常组织中的表达有限，因此它是一种有趣的治疗靶点，可以避免脱靶副作用。”葛兰素史克（GSK）全球肿瘤学研发主管赫沙姆·阿卜杜拉（HeshamAbdullah）说，广泛期小细胞肺癌具有侵袭性，预后不良，迫切需要新的治疗方法。在去年的ASCO大会上提交的第一阶段数据显示，40名（85%）重度预处理的SCLC，非小细胞肺癌（NSCLC）和肉瘤患者中有34名看到了疾病控制的证据，其中14名部分缓解。

The results were particularly strong in the SCLC subgroup, with seven out of nine patients showing signs of tumour shrinkage.Patients in this situation have typically seen disease progression on or after chemotherapy, with very few treatment options remaining to them.SCLC accounts for around 15% of all lung cancers in the US, and 70% of cases have extensive-stage disease, meaning the cancer has spread throughout one or both lungs and/or to other parts of the body.

SCLC亚组的结果特别强烈，九分之七的患者表现出肿瘤缩小的迹象。这种情况下的患者通常在化疗时或化疗后出现疾病进展，剩下的治疗选择很少。小细胞肺癌约占美国所有肺癌的15%，70%的病例患有广泛的阶段性疾病，这意味着癌症已经扩散到一个或两个肺部和/或身体的其他部位。

Once it reaches that stage, the five-year survival rate is very low at around 3%.Breakthrough status 'supports our ambition to accelerate GSK'22.

一旦达到这个阶段，五年生存率非常低，约为3%。突破性地位“支持我们加速葛兰素史克的雄心壮志”22。