New survival data boosts AZ’s lung cancer drug

Updated progression-free survival data for AstraZeneca’s lung cancer candidate AZD9291 has put the drug firmly on course for filing in the first half of this year.

Updated results from the ongoing AURA trial of AZD9291 suggest it can extend survival in patients with advanced epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer – who also have the T790M resistance mutation – by 13.5 months.

The data reinforce AZ’s view that its cancer pipeline is the sixth growth platform for the company alongside respiratory medicine, diabetes, antithrombotic Brilinta (ticagrelor), Japan and emerging markets.

Last year – whilst in the throes of fighting the takeover bid from Pfizer – AZ suggested AZD9291 could develop into a $3 billion-a-year product, in part because of the lack of effective therapies for NSCLC patients with the T790M mutation.

The company is in competition in this area with Clovis Oncology, whose NSCLC treatment CO-1686 is targeting the same patient group and is pitching for a filing at around the same time.

The latest AURA results indicate an overall response rate of 54 percent in patients treated with AZD9291 – epidermal growth factor receptor (EGFR) inhibitor – when given at an oral dose of 80mg per day.

It also directly targets the T790M mutation which is found in 60 percent of NSCLKC patients and is the most common form of resistance to current EGFR-acting therapies such as AZ’s Iressa (gefitinib) or Roche/Astellas’ Tarceva (erlotinib).

The potential value of AZ’s candidate has also been recognised the FDA, which has granted AZD9291 breakthrough therapy designation, orphan drug and fast-track status.

AZ has traditionally been a major player in oncology, although it entered a slightly fallow development period in the last few years which it has since addressed, in part via an extensive in-licensing and partnering programme.

The company now has 15 cancer projects in late-stage development or at the registration phase, according to its latest pipeline update, and is anticipating upwards of eight approvals before the end of next year, including anti-PDl1 candidate MEDI4736 which should report results in NSCLC at this year’s American Society of Clinical Oncology (ASCO) meeting.

Amongst its other candidates, MEK inhibitor selumetinib has just been awarded orphan drug status by the FDA for the treatment of uveal melanoma, while AZ reported earlier this week that anti-CTLA-4 antibody tremelimumab had been given the same designation for malignant mesothelioma.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.