Pictured: AstraZeneca building in Gothenburg/iStock, Wirestock

图：阿斯利康在哥德堡/伊斯托克建筑

The partnership that brought Enhertu to the market is gearing up for another potential breast cancer blockbuster. AstraZeneca and Daiichi Sankyo announced positive high-level Phase III results for their TROP2-directed antibody-drug conjugate Friday, with plans for regulatory submissions underway.

将Enhertu推向市场的合作伙伴关系正在加速另一个潜在的乳腺癌大片。阿斯利康和第一三共宣布其TROP2定向抗体-药物偶联物周五的积极高水平III期结果，并计划提交监管。

In the TROPION-Breast01 Phase III trial, datopotamab deruxtecan (Dato-DXd) improved progression-free survival (PFS) for patients with HR-positive, HER2-low or negative breast cancer compared to chemotherapy. Data were not yet mature for overall survival (OS), but “a trend in improvement” was observed, according to the companies.

在TROPION-Breast01 III期临床试验中，与化疗相比，datopotamab deruxtecan（Dato DXd）改善了HR阳性，HER2低或阴性乳腺癌患者的无进展生存期（PFS）。据这些公司称，总体生存（OS）的数据尚未成熟，但观察到“改善趋势”。

Patients in the trial had previously failed to achieve remission after at least one systemic therapy and an endocrine-based therapy. .

试验中的患者在至少一次全身治疗和基于内分泌的治疗后未能达到缓解。 .

More details are expected to be presented at an upcoming meeting and “shared with health authorities,” the companies announced. Additional Phase III trials are underway across other disease subtypes including triple-negative breast cancer.

这些公司宣布，预计将在即将召开的会议上介绍更多细节，并“与卫生当局分享”。其他疾病亚型包括三阴性乳腺癌正在进行额外的III期临床试验。

The TROP2-directed antibody-drug conjugate (ADC) treatment combines monoclonal antibodies with chemotherapy to seek out tumors before delivering its cancer-killing payload, with the goal of sparing healthy cells. AstraZeneca and Daiichi Sankyo inked a $6 billion pact for Dato-DXd in 2020, building on their joint success with bringing Enhertu to the market.

TROP2定向抗体-药物偶联物（ADC）治疗将单克隆抗体与化学疗法相结合，在递送其杀死癌症的有效载荷之前寻找肿瘤，目的是节省健康细胞。阿斯利康（AstraZeneca）和第一三共（Daiichi Sankyo）在2020年为Dato DXd签署了60亿美元的合同，这是基于他们在将Enhertu推向市场方面的共同成功。

Daiichi Sankyo will hold exclusive rights in Japan while the development and commercialization expenses and profits will be split elsewhere across the globe. .

第一三共将在日本拥有专有权，而开发和商业化费用和利润将在全球其他地方分摊。 .

In an earlier trial for non-small cell lung cancer (NSCLC), the ADC treatment showed statistically significant PFS improvement but was trending toward an insignificant improvement for its secondary endpoint OS. The underwhelming results in NSCLC dropped AstraZeneca’s shares in July 2023, while the release of  the TROPION-Breast01 trial data had the company’s stock price up about 2% Friday morning. .

在早期的非小细胞肺癌（NSCLC）试验中，ADC治疗显示PFS有统计学意义的改善，但其次要终点OS的改善趋势不明显。NSCLC令人沮丧的结果在2023年7月下跌了阿斯利康的股票，而TROPION-Breast01试验数据的发布使得该公司周五早上的股票价格上涨了约2%。 .

If approved, Data-DXd will be pitted against Gilead’s Trodelvy, which was the first TROP2-directed ADC approved in 2020 and then expanded to the breast cancer population AstraZeneca and Daiichi Sankyo targeted in the TROPION-Breast01 trial. The current approval has Trodelvy as a third-line treatment.

如果获得批准，数据DXd将与Gilead的Trodelvy进行对比，Gilead的Trodelvy是2020年批准的第一个TROP2导向ADC，然后扩展到TROPION-Breast01试验中针对的乳腺癌人群AstraZeneca和Daiichi Sankyo。目前的批准已将Trodelvy作为三线治疗。

It is the first TROP2-directed ADC to demonstrate OS benefit in HR-positive, HER2 metastatic breast cancer patients who had received prior endocrine-based therapy and at least two chemotherapies.  .

这是第一个TROP2定向ADC，用于证明先前接受过内分泌治疗和至少两种化疗的HR阳性，HER2转移性乳腺癌患者的OS益处。 .

Trodelvy is expected to become a blockbuster for Gilead this year with sales in the first six months of 2023 raking in $460 million. The company gained access to the ADC in a $21 billion buy of its maker, Immunomedics, in 2020.

预计Trodelvy今年将成为Gilead的重磅炸弹，2023年的前六个月销售额为4.6亿美元。2020年，该公司以210亿美元的制造商Immunomedics收购ADC。

Breast cancer is the most common cancer in the world, with HR-positive, HER2-low or negative its most common subtype. Analysts from GlobalData predicted Daiichi Sankyo will remain dominant in the ADC market for cancer, with global sales forecasted at $10.8 billion by 2029.

乳腺癌是世界上最常见的癌症，HR阳性，HER2低或阴性是其最常见的亚型。来自GlobalData的分析师预测，第一三共将在ADC癌症市场中占据主导地位，到2029年全球销售额预计将达到108亿美元。

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

凯特·古德温（Kate Goodwin）是位于爱荷华州Des Moines的自由职业生命科学作家。她可以到达kate.goodwin@biospace.com并在LinkedIn上。