AstraZeneca is celebrating two new approvals for cancer therapies Imfinzi and Enhertu in the EU as it faces the threat of increased competition to its top seller Tagrisso.

阿斯利康在面临其畅销药物Tagrisso竞争加剧的威胁之际，庆祝了其癌症疗法Imfinzi和Enhertu在欧盟获得两项新批准。

Daiichi Sankyo-partnered anti-HER2 drug Enhertu (trastuzumab deruxtecan) has been cleared by the European Commission for use in advanced breast cancer cases with lower levels of the HER2 biomarker while AZ's PD-1 inhibitor Imfinzi (durvalumab) has claimed approval for use before and after surgery for early-stage non-small cell lung cancer (NSCLC)..

第一三共合作的抗HER2药物Enhertu（trastuzumab deruxtecan）已获欧盟委员会批准，用于治疗HER2生物标志物水平较低的晚期乳腺癌病例；而阿斯利康的PD-1抑制剂Imfinzi（durvalumab）则获批用于早期非小细胞肺癌（NSCLC）手术前后的治疗。

The two approvals – both of which have already been granted in the US – come as AZ's $6.6 billion EGFR inhibitor Tagrisso (osimertinib) is facing a tougher challenge from Johnson & Johnson's rival Rybrevant (amivantamab) and Lazcluse (lazertinib) combination, which

这两项批准——均已经在美国获得通过——正值阿斯利康（AZ）价值66亿美元的EGFR抑制剂塔格里斯（奥希替尼）面临来自强生公司竞争对手药物莱布雷万特（阿米万单抗）与拉兹克鲁塞（拉泽替尼）组合更为严峻的挑战之际，

improved survival

改善的生存率

in a head-to-head trial.

在一对一的试验中。

The Enhertu approval applies to the use of the drug in advanced breast cancers that are HR-positive and either HER2-low or HER2-ultra-low who have previously been treated with one or more lines of endocrine therapy – but are not suitable for another endocrine round.

Enhertu的批准适用于在先前接受过一种或多种内分泌治疗后，HR阳性、HER2低表达或HER2超低表达的晚期乳腺癌患者，但这些患者不适合再进行另一轮内分泌治疗。

It makes Enhertu the first approved option for the HER2-ultralow category, which unlocks a sizeable new patient population and moves the drug up the treatment pathway ahead of chemotherapy. Daiichi Sankyo and AZ have estimated that approximately 60% to 65% of HR-positive, HER2-negative breast cancers are HER2-low and potentially an additional 25% may be HER2-ultra-low..

这使得Enhertu成为首个获批用于HER2极低类别的药物，从而解锁了一个相当大的新患者群体，并使该药物在化疗之前进入治疗路径。第一三共和阿斯利康估计，大约60%至65%的HR阳性、HER2阴性乳腺癌属于HER2低表达，可能还有额外25%属于HER2极低表达。

The approval is based on the results of the

基于以下结果获得批准

DESTINY-Breast06 trial

DESTINY-乳腺癌06试验

, one of the highlights of last year's ASCO congress, which showed a response rate of over 60% with Enhertu and a 38% improvement in progression-free survival (PFS) compared to chemo.

，这是去年ASCO大会的亮点之一，数据显示Enhertu的有效率超过60%，与化疗相比，无进展生存期（PFS）提高了38%。

Enhertu is already a blockbuster, with worldwide sales of more than $3.75 billion last year, up from $2.57 billion in 2023, and the new approval has the potential to unlock further growth.

Enhertu 已经是一个重磅炸弹，去年全球销售额超过 37.5 亿美元，高于 2023 年的 25.7 亿美元，新的批准有可能释放进一步的增长。

The Imfinzi approval covers the use of the drug in combination with chemo pre-surgery and on its own after surgery in NSCLC patients with a high risk of recurrence whose tumours don't express EGFR and ALK mutations that would make them suitable for targeted therapies.

Imfinzi的批准涵盖了在高复发风险的非小细胞肺癌患者中使用该药物，这些患者的肿瘤不表达EGFR和ALK突变，使他们适合靶向治疗。该药物可在术前与化疗联合使用，并在术后单独使用。

It makes the drug an alternative to MSD's PD-1 inhibitor Keytruda (pembrolizumab), which was approved for this perioperative use in early-stage NSCLC, and could lend additional momentum to Imfinzi which grew 21% to $4.7 billion last year.

这使得该药物成为MSD的PD-1抑制剂Keytruda（pembrolizumab）的替代品，后者已获批用于早期非小细胞肺癌的围手术期治疗，同时可能为Imfinzi提供额外推动力，该药物去年增长21%，达到47亿美元。

In the

在

AEGEAN

爱琴海航空

trial, the Enhertu regimen achieved a 32% reduction in the risk of cancer recurrence, progression, or death compared to chemo given alone pre-surgery followed by placebo.

试验显示，与单独术前化疗后使用安慰剂相比，Enhertu方案使癌症复发、进展或死亡的风险降低了32%。

Around 25%-30% of all patients with NSCLC are diagnosed early enough to have surgery to try to cure the cancer but, in most cases, the disease recurs and the five-year survival rate for people with stage II disease is 36% to 46%, according to AZ.

根据阿斯利康的数据，约25%-30%的非小细胞肺癌患者能够在早期确诊并接受手术以试图治愈癌症，但在大多数情况下疾病会复发，II期患者的五年生存率为36%至46%。