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AstraZeneca expands lung cancer immuno-oncology research efforts
AstraZeneca has announced an expansion of its immuno-oncology late-stage clinical development programme in first-line non-small cell lung cancer (NSCLC).
As part of this, a refined endpoints and statistical analysis plan for the phase III MYSTIC trial – which is assessing the benefits of durvalumab monotherapy, as well as a durvalumab plus tremelimumab combination regimen – has been announced by the company.
Initially focused solely on focused on progression-free survival, the trial will now assess both progression-free and and overall survival endpoints in patients with PDL1-expressing tumours, as well as in all comers for the combination regimen.
Additionally, the phase III NEPTUNE trial is to be expanded with local patients to support regulatory submissions for the durvalumab/tremelimumab combination in China for first-line NSCLC patients.
Finally, a new phase III trial called PEARL has been initiated, assessing durvalumab monotherapy in first-line PD-L1-positive NSCLC patients, with a focus on Asian countries due to the high prevalence of this disease in the region.
Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "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."
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