Bristol Myers Squibb has received approval from the European Commission for a perioperative treatment regimen involving Opdivo® (nivolumab) and chemotherapy before surgery, followed by adjuvant Opdivo monotherapy, for adult patients with resectable non-small cell lung cancer (NSCLC) whose tumours express PD-L1 ≥1%..

百时美施贵宝公司已获得欧盟委员会的批准，用于一种围手术期治疗方案，该方案包括在手术前使用欧狄沃®（纳武利尤单抗）联合化疗，以及术后使用欧狄沃单药辅助治疗，适用于肿瘤表达PD-L1≥1%的可切除非小细胞肺癌（NSCLC）成年患者。

Opdivo is a PD-1 immune checkpoint inhibitor that works by enhancing the body’s natural immune response against cancer. It is already approved for use across several cancer types in the EU. The current EC approval builds on earlier authorisation by the U.S. FDA in October 2024, which also used data from the CheckMate -77T trial to support its decision..

Opdivo是一种PD-1免疫检查点抑制剂，通过增强人体对癌症的自然免疫反应起作用。它已经在欧盟被批准用于多种癌症类型。当前的EC批准是基于2024年10月美国FDA的早期授权，该授权同样使用了CheckMate -77T试验的数据来支持其决定。

Non-small cell lung cancer is one of the most prevalent forms of lung cancer globally and accounts for around 84% of cases. While many cases can be treated with surgery, recurrence remains common. Perioperative treatment options are therefore seen as an important step towards improving survival rates in early-stage disease..

非小细胞肺癌是全球最常见的肺癌类型之一，约占病例的84%。尽管许多病例可以通过手术治疗，但复发仍然很常见。因此，围手术期治疗方案被视为提高早期疾病生存率的重要一步。

Opdivo has been approved in more than 65 countries worldwide and is part of a broad clinical development programme by Bristol Myers Squibb, which continues to explore its use across a range of cancers and patient populations.

Opdivo 已在全球超过 65 个国家获得批准，并且是百时美施贵宝公司广泛的临床开发计划的一部分，该计划继续探索其在多种癌症和患者群体中的应用。

The approval applies to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, offering a new treatment option for patients at high risk of disease recurrence.

该批准适用于所有27个欧盟成员国，以及冰岛、列支敦士登和挪威，为高复发风险的患者提供了一种新的治疗选择。

This treatment is intended for patients at high risk of recurrence and aims to improve long-term outcomes by reducing the likelihood of the cancer returning after surgery. The decision follows findings from the Phase 3 CheckMate -77T trial, which showed that the Opdivo-based regimen significantly improved event-free survival (EFS) compared to chemotherapy alone..

该治疗方案适用于复发风险较高的患者，旨在通过降低术后癌症复发的可能性来改善长期疗效。这一决定基于三期临床试验CheckMate -77T的结果，该试验表明，与单独使用化疗相比，基于Opdivo的治疗方案显著改善了无事件生存期（EFS）。

In the study, patients receiving Opdivo plus chemotherapy before surgery, followed by adjuvant Opdivo, had a 42% lower risk of disease recurrence, progression, or death. After a median follow-up of 25.4 months, 65% of patients in the Opdivo group remained event-free at 24 months, compared to 44% in the control group.

在研究中，手术前接受Opdivo联合化疗，随后进行辅助Opdivo治疗的患者，疾病复发、进展或死亡的风险降低了42%。在中位随访25.4个月后，Opdivo组中有65%的患者在24个月时仍然无事件发生，而对照组为44%。

The trial also showed better outcomes in terms of pathologic complete response (pCR) and major pathologic response (MPR)..

试验还显示，在病理完全缓解（pCR）和主要病理缓解（MPR）方面取得了更好的结果。

The safety profile of the regimen was consistent with previous studies in NSCLC, and no new safety issues were reported. The CheckMate -77T trial continues to evaluate overall survival as a key secondary endpoint.

该方案的安全性特征与既往在非小细胞肺癌（NSCLC）中的研究一致，未报告新的安全性问题。CheckMate-77T 试验继续将总生存期作为关键次要终点进行评估。

Source: bms.com

来源：bms.com