IMmotion151研究结果显示：与辉瑞广泛应用的一线索坦相比，联合使用罗氏的PD-L1抑制剂 Tecentriq和 Avastin可使晚期肾癌的PFS（无进展生存）提高26%。

该研究所纳入的人群为先前未经治疗且无法手术的局部晚期或转移性肾癌（RCC）患者，PD-L1表达阳性。去年12月，罗氏首次报道 Tecentriq (atezolizumab) 和Avastin (bevacizumab) 方案完成了其主要治疗目标之一PFS。与舒尼替尼治疗相比，这款组合能让患者的疾病恶化或死亡风险降低26％(中位PFS：11.2个月 vs 7.7个月; p =0.02)。但对于另外一个终点整体生存率OS，公司表示“令人鼓舞，但不成熟”。

罗氏首席医学官Sandra Horning表示：这是Tecentriq和Avastin组合第二次显示出其生存益处，此次结果进一步证明该种独特组合的潜力。去年，IMpower150试验显示：与单用Avastin相比，Tecentriq 和Avastin的组合显示出了在非小细胞肺癌中的PFS获益。

她同时表示：该重磅药物仍将为罗氏带来巨大的销量，但也面临着欧洲和其它地区生物仿制药的竞争威胁。

罗氏首席营销官 Sandra Horning

罗氏希望这一组合的数据能够帮助 Tecentriq 追赶上PD-1/PD-L1类别的领导者地位。

罗氏首席执行官SeverinSchwan在数据发布前对路透社记者说到“我们的目标是成为癌症免疫治疗领域的先锋，而这恰恰是我们站在最前沿的机会。”

罗氏首席执行官 Severin Schwan

IMmotion151的具体数据将于2018年的泌尿生殖系统癌症研讨会（ASCO-GU）上公布。

另外，BMS的 Opdivo (nivolumab) 曾在2015年被批准用于RCC的二线治疗选择，但在一项单药治疗先前未经治疗患者的试验中公布了不一致的结果。

BMS也在考虑将 Opdivo联合CTLA4抑制剂ipilimumab一线治疗RCC。 CheckMate-214的结果显示这种组合在总体生存率和总体反应率上显著优于舒尼替尼，特别是在PD-L1表达阳性的患者中尤为明显。

同时，Merck & Co的Keytruda (pembrolizumab)尚未批准用于RCC的治疗，但该适应症已经在多项临床研究中，包括一项评估其作为新辅助治疗手段的III期临床研究。

Roche unveils data for Tecentriq/Avastin combo in kidney cancer

Pairing Roche’s PD-L1 inhibitor Tecentriq with Avastin reduces progression-free survival in patients with advanced kidney cancer by 26% compared to widely-used first-line treatment Sutent from Pfizer.

The new data from the IMmotion151 trial will be “discussed with global health authorities” including the FDA and EMA according to Roche, which first reported that the Tecentriq (atezolizumab) and Avastin (bevacizumab) regimen achieved one of its therapeutic objectives last December.

Patients on the combination had a progression-free survival of 11.2 months in the study compared to 7.7 months among those on Sutent (sunitinib). The study is also comparing overall survival in the two groups as a co-primary endpoint but those data - while ‘encouraging’ - are not quite ready, said the company.

The trial involved previously untreated patients with inoperable locally-advanced or metastatic renal cell carcinoma (RCC) whose tumours express the PD-L1 biomarker and will be presented at the American Society of Clinical Oncology’s Genitourinary Cancers Symposium later this week.

Roche’s chief medical officer Sandra Horning said the trial is the second to show the benefit of combining Tecentriq with Avastin, one of Roche’s blockbuster cancer drugs that still brings in big sales but is facing the threat of biosimilar competition in Europe and elsewhere. The study “provides further evidence to support the potential of this unique combination”, she added.

Last year, the IMpower150 trial of Tecentriq and Avastin showed that the combination improved PFS in patients with non-small cell lung cancer (NSCLC) compared to Avastin alone.

Roche is hoping that the combination data will help Tecentriq catch-up with the leaders in the PD-1/PD-L1 inhibitor category. Bristol-Myers Squibb’s Opdivo (nivolumab) was approved as a second-line treatment option for RCC in 2015 but posted mixed results in a trial involving previously-untreated patients as a monotherapy.

BMS is also looking at combining Opdivo with its CTLA4 inhibitor Yervoy (ipilimumab) in first-line RCC, and the results of the CheckMate-214 study showed that the combination was superior to Sutent with a statistically significant overall survival benefit and overall response rate, with the effects more pronounced in tumours that expressed PD-L1.

Meanwhile, Merck & Co’s Keytruda (pembrolizumab) is not yet approved to treat RCC but is in several clinical trials in this indication, including a phase III evaluation as a neoadjuvant therapy alongside surgery.