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AZ's Tagrisso beats chemotherapy in lung cancer trial

Phase III data shows greater progression-free survival in mutation-positive NSCLC patients
Tagrisso

AstraZeneca's new targeted drug Tagrisso has become the first drug to improve on chemotherapy in patients with non-small lung cancer (NSCLC) bearing a specific EGFR mutation.

Data from the late-stage AURA 3 trial showed that Tagrisso (osimertinib) reduced the risk of disease progression by 70% and improved progression-free survival (PFS) by almost six months compared to standard therapy in patients with T790M mutation-positive, locally-advanced or metastatic NSCLC.

The phase III data are pretty much in line with the performance of the drug in two mid-stage trials, in which 66% of patients with both mutations saw their tumours shrink with an average PFS of 11 months.

In AURA 3, patients on the drug had a PFS of 10.1 months, compared to 4.4 months for those on chemotherapy, and as expected had far fewer serious adverse events than those on platinum-pemetrexed chemotherapy.

Tagrisso is a third-generation EGFR inhibitor and was the first drug to be approved to treat patients with metastatic EGFR T790M mutation-positive NSCLC. The mutation develops in around two-thirds of patients who have received other EGFR inhibitors, such as Roche/Astellas' $2bn-a-year Tarceva (erlotinib), AstraZeneca's Iressa (gefitinib) and Boehringer Ingelheim's Giotrif (afatinib).

The data suggests that Tagrisso could be a new standard of care for patients with resistance to first-line EGFR inhibitors, said Prof Tony Mok, from the Chinese University of Hong Kong, one of the AURA 3 investigators and lead author on the report of the trial, which has just been published in the New England Journal of Medicine.

"With the publication of the AURA 3 data, clinicians should perform T790M mutation testing to ensure Tagrisso be given to patients who are most likely to benefit," he said.

The results are likely to spur on prescribing of Tagrisso, which is one of AZ's key growth products. Sales of the drug came in at $276m in the first nine months of the year, fuelled by its hefty $150,000 list price in the US.

Analysts at Credit Suisse predicted that it will reach sales of almost $2bn in 2020, providing it eventually gets approved for first- as well as second-line NSCLC therapy.

Article by
Phil Taylor

7th December 2016

From: Research

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