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Imfinzi Demonstrates Clinical Activity In Stage IV, 1st-Line Non-Small Cell Lung Cancer In Phase III MYSTIC Trial

(BioSpace) Dec 13, 2018 - AstraZeneca and MedImmune, its global biologics research and development arm, have presented overall survival (OS) and progression-free survival (PFS) data from the Phase III MYSTIC trial at the European Society for Medical Oncology (ESMO) Immuno-Oncology 2018 Congress in Geneva, Switzerland. The MYSTIC trial evaluated Imfinzi (durvalumab) monotherapy and the combination of Imfinzi plus 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).1 Results show that Imfinzi monotherapy demonstrated clinical activity with an OS hazard ratio (HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) in the primary analysis population of patients whose tumours express PD-L1 on 25% or more of their cancer cells, but this result did not meet statistical significance.

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H. Jack West, MD (Posted: December 14, 2018)

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These data on MYSTIC stave off the executioner for durva or durva/treme in first line treatment of stage IV NSCLC, but I don't think they are favorable enough to call them highly encouraging. The reality today is that the true comparator is no longer doublet chemo alone but chemo with pembrolizumab, with decidedly better outcomes than chemo alone. In this setting, it's hard to conclude that durvalumab measures up even as a lateral move.

And while the TMB gambit provides a post-hoc escape hatch for a growing number of trials that fail on their original prospective design, these results for high TMB patients need not only to be replicated in a prospectively designed trial but need to prove superior to a general approach of chemo/pembro for the PD-L1 0-49% expression population, or pembro monotherapy perhaps for the high PD-L1 subgroup, to reach a tipping point of clear clinical relevance.

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