Kelun-Biotech new drug application (NDA) for sacituzumab tirumotecan (sac-TMT), formerly known as SKB264/MK-2870, has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.Lung cancer is primarily divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC being the most common, accounting for approximately 80%-85% of all lung cancer cases.

科伦生物技术公司（Kelun Biotech）针对sacituzumab tirumotecan（sac TMT）的新药申请（NDA），原名SKB264/MK-2870，已被中国国家医药产品管理局（NMPA）药物评估中心（CDE）接受。肺癌主要分为非小细胞肺癌（NSCLC）和小细胞肺癌（SCLC），其中NSCLC最常见，约占所有肺癌病例的80%〜85%。

In China, the molecular profile of NSCLC patients often includes EGFR mutations, which occur in about 40%-50% of lung adenocarcinoma cases. Current guidelines recommend EGFR-TKIs as the first-line treatment for stage IV EGFR-mutant NSCLC.The OptiTROP-Lung03 study is a multi-centre, randomized clinical trial that evaluated sac-TMT as a monotherapy (5mg/kg every two weeks) administered intravenously, against docetaxel, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.These patients had previously failed treatment with EGFR-tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.

在中国，NSCLC患者的分子谱通常包括EGFR突变，约40%〜50%的肺腺癌病例发生EGFR突变。目前的指南建议将EGFR-TKIs作为IV期EGFR突变NSCLC的一线治疗。OptiTROP-Lung03研究是一项多中心随机临床试验，评估sac TMT作为静脉注射多西紫杉醇的单一疗法（每两周5mg/kg），用于局部晚期或转移性非小细胞肺癌（NSCLC）患者表皮生长因子受体（EGFR）突变。这些患者先前用EGFR酪氨酸激酶抑制剂（TKIs）和铂类化疗失败。

The study demonstrated that sac-TMT significantly improved both the objective response rate (ORR) and progression-free survival (PFS) compared to docetaxel.This acceptance follows positive results from the pivotal OptiTROP-Lung03 study, as announced by Sichuan Kelun-Biotech Biopharmaceutical.However, when resistance to EGFR-TKIs develops, platinum-based chemotherapy is typically used, though it is not very effective for patients who have failed both EGFR-TKIs and platinum-based treatments.

该研究表明，与多西紫杉醇相比，sac TMT显着提高了客观缓解率（ORR）和无进展生存期（PFS）。正如四川科伦生物技术生物制药公司宣布的那样，这一接受是基于关键的OptiTROP-Lung03研究的积极结果。然而，当对EGFR-TKIs产生耐药性时，通常会使用铂类化疗，尽管它对EGFR-TKIs和铂类治疗均失败的患者不是很有效。

Docetaxel, the standard single-agent chemotherapy in such cases, has low efficacy, with ORR ranging from 3.2% to 10.8%, a median PFS of about 2 months, and a median overall surviva.

多西紫杉醇是这种情况下的标准单药化疗，疗效较低，ORR范围为3.2%至10.8%，中位PFS约为2个月，中位总生存期。