durvalumab 单药及联合tremelimumab一线治疗晚期NSCLC未达到主要终点

手机编辑，敬请见谅。

AstraZeneca provides update on the Phase III MYSTIC trial of Imfinzi and tremelimumab in Stage IV non-small cell lung cancer

MYSTIC研究是一项随机、开放标签、多中心的全球研究，评估抗PD-L1单抗Durvalumab及联合抗CTLA-4单抗对比标准化疗治疗先前未治的IV期NSCLC。

在主要分析人群也就是PD-L1≥25（SP263）的患者中，单药和联合相比标准化疗都没有改善OS，单药组HR 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) 联合组 HR 0.85 (98.77% CI 0.611-1.173; nominal p=0.202)。

虽然之前从纯粹学术的角度不看好这个研究，但真的不达终点，还是一声叹息！

When you walk through a storm

Hold your head up high

And don't be afraid of the dark

At the end of the storm

There's a golden sky

And the sweet silver song of a lark

Walk on through the wind

Walk on through the rain

AstraZeneca and MedImmune, its global biologics research and development arm, today announced final overall survival (OS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).

In the primary analysis population of patients, whose tumours express PD-L1 on 25% or more of their cancer cells as determined by the VENTANA PD-L1 (SP263) Assay, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy. While the OS result did not meet statistical significance, a hazard ratio (HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) was observed with Imfinzimonotherapy. The combination therapy had an HR of 0.85 (98.77% CI 0.611-1.173; nominal p=0.202); the data support further analysis in exploratory subgroups.

The safety and tolerability profiles for Imfinzi and the Imfinzi plus tremelimumab combination were consistent with previous trials.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “We are encouraged to see that Imfinzimonotherapy activity is in-line with that of the anti-PD-1 class in previously-untreated patients with Stage IV non-small cell lung cancer; however, we are disappointed that these results missed statistical significance. We remain confident in Imfinzi as the cornerstone of our IO programme and continue to evaluate its potential in ongoing non-small cell lung cancer trials, including Imfinzi and Imfinzi plus tremelimumab in combination with chemotherapy.”

Imfinzi is approved for unresectable, Stage III NSCLC in more than 40 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial. Imfinzi is currently being tested in a range of Phase III trials for Stage IV NSCLC.

About MYSTIC

The MYSTIC trial is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi (durvalumab) monotherapy or Imfinzi in combination with tremelimumab versus SoC chemotherapy in the 1st-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type, locally-advanced or metastatic (Stage IV) non-small cell lung cancer.

The trial was conducted in 167 centres across 17 countries, including the US, Canada, Europe, Russia, Australia and parts of Asia, including Japan, Korea, Thailand, Taiwan and Vietnam. Primary endpoints included progression-free survival (PFS) for the combination, and OS in monotherapy and in combination therapy. The combination of Imfinzi and tremelimumab did not meet the primary endpoint of improving PFS compared to SoC in patients whose tumours express PD-L1 on 25% or more of their cancer cells in July 2017.