AstraZeneca has provided updates on some of its cancer related clinical trials including 1st-line non-small cell lung cancer (NSCLC). and a refinement of the Phase III Mystic trial.
The aim of the initial trial was to see compare durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combo with standard-of-care (SoC) chemotherapy, focused on progression-free survival (PFS).
The trial will now assess PFS and overall survival (OS) endpoints in patients with PDL1-expressing tumours for both durvalumab monotherapy and the combination of durva + treme, as well as in ‘all comers’ for the combination of durva + treme, versus SoC chemotherapy.
AstraZeneca will focus on durva + treme combo, and it has updated the endpoints of the Mystic trial to include OS and PFS in durvalumab monotherapy.
The date for the results has been updated and are expected in mid-2017 and final OS data at the latest in 2018. Mystic also includes several undisclosed interim analyses for OS.
Additionally, 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. AstraZeneca has also begun 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 focuses on Asian countries, primarily China, due to the high prevalence of NSCLC in the region.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “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.”