A perioperative regimen for muscle-invasive bladder cancer (MIBC) based on AstraZeneca's Imfinzi and Astellas/Pfizer's Padcev has improved survival in the VOLGA study, but the jury is out on whether it will displace a rival, established alternative.

在VOLGA研究中，基于阿斯利康的Imfinzi和安斯泰来/辉瑞的Padcev的肌层浸润性膀胱癌（MIBC）围手术期方案提高了生存率，但其是否会取代已有的竞争性替代方案仍尚无定论。

VOLGA was conducted in patients with MIBC ineligible or unwilling to take platinum-based chemotherapy, who received PD-L1 inhibitor Imfinzi (durvalumab) before and after surgery to remove the tumour, and Nectin-4-targeting Padcev (enfortumab vedotin) before surgery only.

VOLGA 研究针对的是不适合或不愿接受含铂化疗的肌层浸润性膀胱癌（MIBC）患者，这些患者在肿瘤切除手术前后接受了 PD-L1 抑制剂 Imfinzi（度伐利尤单抗），并仅在术前接受了靶向 Nectin-4 的 Padcev（恩福尤单抗）。

The main result was a 42% reduction in the risk of death compared to standard therapy based on surgery to remove the bladder altogether, putting a number on a

主要结果是，与基于完全切除膀胱手术的标准治疗相比，死亡风险降低了42%，从而为

top-line result

顶层结果

first disclosed in May. Meanwhile, event-free survival (EFS) was improved by 49%, at 23 months for the drug group and 12.1 months for the control. Adding AZ's CTLA4 inhibitor Imjudo (tremelimumab) to the regimen delivered no added benefit.

首次披露于五月。与此同时，无事件生存期（EFS）改善了49%，药物组为23个月，对照组为12.1个月。在方案中加入阿斯利康的CTLA-4抑制剂Imjudo（曲美木单抗）并未带来额外获益。

The results were published in the

结果发表在

New England Journal of Medicine

新英格兰医学杂志

alongside the presentation at ESMO by lead investigator Thomas Powles of Barts Health NHS Trust.

由巴茨健康 NHS 信托基金会的首席研究员托马斯·鲍尔斯在 ESMO 会议上进行报告。

'Patients with muscle-invasive bladder cancer require life-changing bladder removal surgery. Despite this, the cancer returns in about half of patients,' he said. 'These practice-changing results support this approach as a patient-centric, potential new standard of care in this setting.'

“肌层浸润性膀胱癌患者需要接受改变生活的膀胱切除手术。尽管如此，约有一半患者的癌症会复发，”他说。“这些足以改变临床实践的结果支持将该方法作为一种以患者为中心的、潜在的新标准治疗方案。”

The big debate at ESMO was how the result fits in with evolving views on neoadjuvant and adjuvant drug therapy in MIBC, in light of the impressive results seen with a regimen based on MSD's Keytruda (pembrolizumab) and Padcev, both given before and after surgery to cisplatin-ineligible patients, in the .

在ESMO大会上，备受关注的议题是如何将这一结果纳入对肌层浸润性膀胱癌（MIBC）新辅助和辅助药物治疗不断演变的观点中，鉴于基于默沙东的Keytruda（帕博利珠单抗）和Padcev的方案在不符合顺铂使用条件的患者中术前和术后给药所取得的令人瞩目的结果。

KEYNOTE-905 and KEYNOTE-B15

KEYNOTE-905 和 KEYNOTE-B15

trials.

试验。

It also raises a question for Padcev, which would see its use truncated in the adjuvant setting if the VOLGA data proves compelling for oncologists. One consideration is that the regimen had relatively low rates of peripheral neuropathy, a recognised Padcev side effect, which could make it more attractive for patients..

这也给Padcev带来了一个问题，如果VOLGA数据对肿瘤科医生具有说服力，那么Padcev在辅助治疗环境中的使用将会受到限制。一个考虑因素是该方案的外周神经病变发生率相对较低，而外周神经病变是Padcev已知的副作用，这可能会使其对患者更具吸引力。

On the other hand, it's unclear whether some patients would derive further benefit from adjuvant use of Padcev, according to ESMO commentator Michiel van der Heijden of the Netherlands Cancer Institute, who said that this should be the subject of future investigations.

另一方面，荷兰癌症研究所的欧洲肿瘤内科学会（ESMO）评论员Michiel van der Heijden表示，目前尚不清楚部分患者是否能从Padcev的辅助使用中进一步获益，他指出这应成为未来研究的课题。

'Data on ADCs plus immune checkpoint inhibitors in bladder cancer are now robust and consistent, whereas immune checkpoint inhibitors and chemotherapy in bladder cancer have shown less consistency,' added van der Heijden.

“关于抗体药物偶联物（ADCs）联合免疫检查点抑制剂治疗膀胱癌的数据现已确凿且一致，而免疫检查点抑制剂联合化疗在膀胱癌中的疗效则表现出较低的一致性。”van der Heijden补充道。

Bladder cancer has been billed by AZ as a 'meaningful new opportunity' for Imfinzi, which brought in more than $6 billion in sales for AZ last year is already approved as a peri-operative regimen for MIBC in combination with platinum chemo, based on the

阿斯利康将膀胱癌称为Imfinzi的一个“有意义的新机遇”。Imfinzi去年为阿斯利康带来了超过60亿美元的销售额，并且基于相关研究数据，已获批联合铂类化疗作为肌层浸润性膀胱癌（MIBC）的围手术期治疗方案。

NIAGARA

尼亚加拉

trial, along with other indications in gastric, lung, liver, endometrial, and biliary tract cancers.

试验，以及在胃癌、肺癌、肝癌、子宫内膜癌和胆道癌中的其他适应症。