One of AstraZeneca’s ($AZN) key drugs for its ambitious sales target Tagrisso (osimertinib) has hit its marks in a Phase III test for certain lung cancer patients--passing a key FDA confirmatory study request.
The Anglo-Swedish Big Pharma said its AURA3 trial met its primary endpoint by boosting progression-free survival (PFS) rates higher than standard platinum-based doublet chemotherapy.
The study was looking at Tagrisso as a second-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease had progressed following first-line EGFR TKI therapy.
In addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy. Numbers were not disclosed but will be at an upcoming medical meeting. Data on overall survival, which is currently ongoing, will also be shared, according to Astra.
It has, however, consistently demonstrated solid efficacy in other clinical trials, more recently demonstrating median progression-free survival of 8.6 months in a midstage study.
The tablet is already on the market, being swiftly approved by the FDA last year in patients whose tumors have an EGFR mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.
Given how quickly it was approved, the FDA green light was conditional on AZ producing confirmatory studies--with the positive AURA3 now making it very unlikely the regulator would yank the drug off the market for not working.
The pill is a key product for the company and its highly ambitious company-wide sales target of making $45 billion by 2023. Tagrisso is set to make around $3 billion at peak.
Sean Bohen, EVP of global medicines development and CMO at AstraZeneca, said: “These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients. The AURA3 results demonstrate the benefits of our science-led approach that enabled the rapid development of Tagrisso as a targeted treatment to address the most common cause of resistance to a first-generation EGFR-TKI for patients with metastatic EGFR-mutant lung cancer. We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need.”
The company said the goal with the drug was to now move itself up the treatment pathway, explaining in a statement it wants to “explore the potential” of Tagrisso both on its own and in combination with other meds for patients with lung cancer in first-line EGFRm settings.
Being used as the first-choice treatment in this setting would boost its sales, and help it toward the $3 billion peak goal.
AZ already markets Iressa (gefitinib) as a first-line treatment for advanced NSCLC patients whose tumors harbor specific types of EGFR gene mutations. The drug made $543 million last year, down 2% at constant exchange rates.
Lung cancer is the leading cause of cancer death in the U.S., with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute.
There are a number of drugs on the market for the disease for different settings and for different mutations, including those from Roche ($RHHBY) and more recently from Pfizer ($PFE).
Bitter rivals Merck ($MRK) and Bristol-Myers Squibb ($BMY) are currently locking horns in a battle to see who can get their PD-1 checkpoint inhibitor drug approved in a first-line setting for NSCLC patients--something which could change the face of this market.
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