17 January 2017
AstraZeneca has provided an update on its Immuno-Oncology (IO) late-stage clinical development program in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial.
The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) chemotherapy, focused on progression-free survival (PFS). The MYSTIC trial will now assess PFS and overall survival (OS) endpoints in patients with PDL1-expressing tumours for both the combination of durva + treme and durvalumab monotherapy, as well as in ‘all comers’ for the combination of durva + treme, versus SoC chemotherapy.
Furthermore, the ongoing Phase III NEPTUNE trial will be expanded with local patients to support regulatory submission of durva + treme combination therapy in China for 1st-line NSCLC patients without delaying the anticipated OS data readout in 2018 from the global cohort, which is approaching full recruitment. The Company has also started the new Phase III PEARL trial of durvalumab monotherapy versus SoC chemotherapy in 1st-line NSCLC patients whose tumours express PD-L1. The PEARL trial emphases on Asian countries, mainly China, due to the high prevalence of NSCLC in the region.
“The MYSTIC trial amendments, the NEPTUNE trial expansion and initiation of the new PEARL trial are all designed to enhance our options in 1st-line NSCLC for IO-IO combination as well as for IO monotherapy. We continue to follow the science through both internal and external sources for the benefit of patients and look forward to sharing our first pivotal data in mid-2017,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.