Aura series studies and the approval of Targisso
AstraZeneca’s (AZN) drug Targisso, also known as AZD9291, was recently approved by the US FDA based on the data of two Aura Phase II studies, namely Aura 2 and Aura extension. These studies demonstrated the safety and efficacy of Targisso, the results are discussed below.
Aura Phase II studies
Aura Phase II studies included two studies, Aura 2 and Aura extension. These studies involved 411 patients with advanced EGFR T790M mutation-positive non-small cell lung cancer (or NSCLC), who had already been treated with an EGFR-blocking medication. The overall objective response rate (or ORR), a measure of tumor shrinkage, was 59% during these trials. Also, ORR was 51% during the supportive phase I study involving 63 patients.
Further developments for Tagrisso
Tagrisso has been approved under an accelerated assessment program, and its confirmatory-trials study is under process. For Tagrisso, the Aura Phase III study, Aura3, is the confirmatory trial designed to assess the efficacy and safety of AZD9291 versus platinum-based doublet chemotherapy for patients with advanced EGFR T790M mutation-positive NSCLC, who had already been treated with an EGFR-blocking medication.
The company is also investing in AZD9291 for its efficacy to be used as a primary treatment as well as in adjuvant setting, that is, to give AZD9291 in addition to primary treatment, including other compounds.
The company has collaborated with Roche to develop Cobas EGFR Mutation Test v2—intended to identify a range of EGFR mutations in patients with NSCLC—as a companion diagnostic for AZD9291.
Approval status for Tagrisso
In the United States, Tagrisso was granted a breakthrough therapy designation, priority review, and an orphan drug designation. Following these, the drug was approved under the accelerated approval program as discussed earlier.
In Europe and Japan, AZD9291 was granted Accelerated Assessment and Priority Review status, respectively. The company is also working on getting approval for Tagrisso from other regulatory authorities worldwide.