Imfinzi demonstrates clinical activity in Stage IV, 1st-line NSCLC in Phase III

AstraZeneca (LSE: AZN) and its global biologics research and development arm MedImmune, 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).

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 tumors express PD-L1 on 25% or more of their cancer cells, but this result did not meet statistical significance. After two years of follow-up, the OS rate for treatment with Imfinzimonotherapy was 38.3% versuss22.7% with SoC. This difference was observed despite a group of patients in the SoC arm (39.5%) that received subsequent immunotherapy following chemotherapy treatment. The combination of Imfinzi plus tremelimumab did not meet the PFS or OS primary endpoints.