AstraZeneca and Daiichi Sankyo have claimed FDA approval for a second antibody-drug conjugate (ADC) for breast cancer, hoping to build on the success of a partnership that already spawned a blockbuster drug.

阿斯利康（AstraZeneca）和第一三共（Daiichi Sankyo）已宣布FDA批准用于乳腺癌的第二抗体药物偶联物（ADC），希望在已经产生了一种重磅炸弹药物的合作伙伴关系的成功基础上再接再厉。

The US regulator has cleared TROP2-directed ADC datopotamab deruxtecan (Dato-DXd) under the Datroway trade name as a treatment for previously treated HR+/HER2- breast cancer, a few weeks after its first world approval in

美国监管机构在年首次获得世界批准几周后，已批准以Datroway商品名使用TROP2指导的ADC datopotamab deruxtecan（Dato DXd）治疗先前治疗过的HR+/HER2乳腺癌

Japan

日本

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Datroway is the second ADC brought to market by AZ and Daiichi Sankyo after Enhertu (trastuzumab deruxtecan), a HER2-targeting ADC that brought in sales of more than $2.7 billion in the first nine months of 2024 – up from $1.8 billion in the same period of 2023 – from half a dozen indications across breast, lung, and gastric cancer as well as HER2-positive solid tumours..

Datroway是AZ和Daiichi Sankyo继Enhertu（曲妥珠单抗deruxtecan）之后推出的第二个ADC，Enhertu是一种针对HER2的ADC，2024年前9个月销售额超过27亿美元，高于2023年同期的18亿美元，来自乳腺癌，肺癌和胃癌以及HER2阳性实体瘤的六个适应症。。

The FDA approval of Datroway is based on the results of the TROPION-Breast01 study, which showed that patients treated with the ADC had a median progression-free survival (PFS) of 6.9 months compared to 4.9 months for those receiving physicians' choice of chemotherapy, a 37% improvement.

FDA对Datroway的批准是基于TROPION-Breast01研究的结果，该研究表明，接受ADC治疗的患者的中位无进展生存期（PFS）为6.9个月，而接受医生选择化疗的患者为4.9个月，改善了37%。

'Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy,' said Aditya Bardia of UCLA Health Jonsson Comprehensive Cancer Centre, the principal investigator in TROPION-Breast01..

“尽管在HR阳性，HER2阴性转移性乳腺癌治疗领域取得了相当大的进展，但仍需要新的疗法来应对内分泌和初始化疗后疾病进展的频繁和复杂挑战，”加州大学洛杉矶分校健康Jonsson综合癌症中心的Aditya Bardia说，他是TROPION-Breast01的首席研究员。。

She added that Datroway's approval 'marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.'

她补充说，达特罗韦的批准“标志着一个重大的治疗里程碑，为转移性乳腺癌患者提供了传统化疗的新治疗替代方案。”

Only one in three patients with this type of breast cancer live more than five years following diagnosis.

这种类型的乳腺癌患者中只有三分之一的患者在诊断后存活超过五年。

Other indications

AZ and Daiichi Sankyo have aspirations to extend the uses of Datroway into other types of cancer, including locally advanced or metastatic non-small cell lung cancer (NSCLC), but were forced to pull their marketing applications for the drug as a second-line therapy for this indication in the US and EU after feedback from regulators suggested the data from their pivotal .

AZ和Daiichi Sankyo希望将Datroway的使用扩展到其他类型的癌症，包括局部晚期或转移性非小细胞肺癌（NSCLC），但在监管机构的反馈表明他们的关键数据后，他们被迫撤回了该药物的营销申请，作为美国和欧盟该适应症的二线治疗。

TROPION-Lung01

TROPION-肺01

study was not strong enough to support approval.

这项研究不足以支持批准。

It wasn't a compelling result, with a two-month improvement in PFS benefit in non-squamous NSCLC patients only, with little impact in the squamous group, prompting Daiichi Sankyo and AZ to try unsuccessfully for a narrower indication. Subsequently, a trend to an improvement in overall survival (OS) in the non-squamous patients .

这并不是一个令人信服的结果，只有非鳞状NSCLC患者的PFS获益改善了两个月，而鳞状组的影响很小，这促使第一三共和AZ尝试缩小适应症的范围失败。随后，非鳞状细胞癌患者的总生存率（OS）有改善的趋势。

failed

失败

to become statistically significant.

具有统计学意义。

Towards the end of last year, the two partners opted to refile Datroway based on the mid-stage TROPION-Lung05 trial, which is looking at the use of the ADC in a heavily pretreated group of EGFR-mutated NSCLC patients, backed up by data from TROPION-Lung01 and TROPION-PanTumor01. Last week the FDA granted that indication a priority review..

去年年底，两位合作伙伴选择根据中期TROPION-Lung05试验重新填充Datroway，该试验正在研究ADC在经过严重预处理的EGFR突变NSCLC患者中的应用，并得到了TROPION-Lung01和TROPION-PanTumor01的数据支持。上周，美国食品和药物管理局（FDA）对该指示进行了优先审查。。

Meanwhile, several other studies of Datroway are ongoing as the partners chase down what AZ has predicted could be peak sales of around $5 billion for the drug.

与此同时，随着合作伙伴追查AZ预测该药物的最高销售额可能达到约50亿美元，Datroway的其他几项研究正在进行中。

Near-term readouts include the TROPION-Breast02 study comparing the ADC to chemotherapy in advanced triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitor therapy, and the AVANZAR study of Datroway plus AZ's PD-1 inhibitor Imfinzi (durvalumab) and chemotherapy in previously untreated advanced NSCLC..

近期读数包括TROPION-Breast02研究，比较ADC与不符合PD-1/PD-L1抑制剂治疗条件的晚期三阴性乳腺癌（TNBC）的化疗，以及Datroway plus AZ的PD-1抑制剂Imfinzi（durvalumab）的AVANZAR研究和先前未治疗的晚期NSCLC的化疗。。