Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘AZD9291 AURA Trial’

European Lung Cancer Conference 2015Geneva – at the 2015 European Lung Cancer Conference today, Pasi A. Jänne, MD, PhD presented updated progression free survival and duration of response data for the phase 1 AURA trial of AZD9291 (AstraZeneca) in patients with EFGR-TKI-resistant advanced non-small cell cancer (Abstract LBA3).

Dr Jänne (pictured below at ASCO 2014) is Director, Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School.

Dr Pasi Jänne ASCO 2014

It’s hard to believe that it is only about two years since the first patient was enrolled in the phase 1 AURA trial of AZD9291, a third generation EGFR inhibitor. If the FDA regulatory submission takes place, as expected, in the second quarter of this year, then the drug could be approved for sale in the United States before the year end.

It has been fascinating to watch the race to market between rociletinib (Clovis Oncology) and AZD9291. It’s likely both could be approved in the United States before the year end.

That would be great news for lung cancer patients, given the absence of any approved therapy for patients who develop a T790M mutation and become resistant to EGFR inhibitors, such as Tarceva and Iressa.

Readers will know that we have been following the phase 1 AURA trial of AZD9291 since ECCO 2013 in Amsterdam, when the first clinical data was presented.

AstraZeneca are to be congratulated on what is a case study of rational scientific drug development; their path to market strategy highlights the benefit of well-designed early clinical trials. AZD9291 may end up receiving regulatory approval less than three years from the start of the first in man trial – that’s tremendous!

I had the privilege to interview Dr Jänne at ASCO last year, and again earlier this week, before he left Boston for Geneva and chatted with him about his AZD9291 presentation at European Lung.

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Post ASCO 2014, many journalists and commentators have hotly declared the third-generation EGFR inhibitor CO-1686 from Clovis Oncology to be a “loser.”

AstraZeneca have a competitor compound AZD9291 also in early stage development.  We’ve been keenly following both compounds on the blog over the past year.

While the Clovis share price has dropped, we are certainly not declaring Clovis CO-1686 to be a loser at ASCO 2014, nor are we declaring AZD9291 to be winner – with no median survival data mature yet, it’s far too soon to call it either way.

For this piece, we interviewed Dr Pasi Jänne (DFCI) who presented the AZD9291 data at ASCO and Dr Lecia Sequist (MGH) who presented the CO-1686 data. We also gained perspectives from Dr Ross Camidge (Univ of Colorado), who has participated in both trials.

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Clovis Oncology ($CLVS) is one of the winners at the JPM Morgan Healthcare conference (#JPM14) in San Francisco with a dramatic increase in share price over the past several days.

The presentation by Clovis CEO Patrick Mahaffy laid out an aggressive growth plan for drugs in development such as CO-1686 and was clearly well received by analysts and investors alike.

CO-1686 is a third-generation EGFR inhibitor with early data showing that is effective in many non-small cell lung cancer (NSCLC) patients who have developed acquired resistance to existing EGFR TKIs.

There are currently no approved treatments for patients who develop a T790 mutation. This unmet medical need offers a sizeable market opportunity as the commercial landscape currently stands.

Clovis, however, are in a race to market with AstraZeneca, who also have an exciting new drug in development, AZD9291.  Preliminary data has shown the agent to also be effective in NSCLC patients with the T790M mutation.

Both companies presented data at the World Lung Conference in Sydney at the end of October last year for their phase 1 trials.

As to which company will get to market first and which product is the best, the race to market is now too close to call and we don’t yet have enough data to compare the merits of the compounds but the JP Morgan Healthcare conference did offer insights.

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AZD9291 AURA Study World LungSydney – AstraZeneca AZD9291 is now ahead of Clovis Oncology CO-1686 in the race to bring a third-generation epidermal growth factor receptor (EGFR) inhibitor to market that targets the T790M resistance mutation.

That is the conclusion I took from the updated preliminary phase 1 data for the AURA study of AZD9291 in non-small cell lung cancer (NSCLC) presented today at the 15th World Conference on Lung Cancer in Sydney, Australia.  Clovis Oncology presented updated phase 1 data for CO-1686, their third-generation EGFR inhibitor, in Sydney earlier this week.

EGFR inhibitor resistance occurs in most NSCLC patients within 10-11 months with approx. 50-60% developing a gatekeeper mutation called T790M.

There are no approved treatments for NSCLC patients with T790M mutations, so this unmet medical need represents a large commercial market opportunity.

Why do I think that AstraZeneca are now ahead of Clovis Oncology and what does the World Lung data show for both drugs?

Susan Galbraith MD PhD at Molecular Targets Press BriefingBoston – At the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics conference, Susan Galbraith, M.D, Ph.D. Head of the Oncology Innovative Medicines Unit at AstraZeneca discussed the development of AZD9291, a potent and selective third-generation EGFR inhibitor of both activating and wild type T790M mutations in non-small cell lung cancer (NSCLC).

Dr Galbraith reviewed the three abstracts presented at Molecular Targets and answered questions on the AZD9291 clinical data presented at ECCO 2013 in Amsterdam.

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Amsterdam – Promising preliminary phase 1 data for AstraZeneca’s AZD9291 in T790M+ NSCLC presented today at the European Cancer Congress (ECCO 2013) is good news for lung cancer patients, but a major competitive threat to Clovis Oncology who look like they are now in a race to bring CO-1686 to market in this indication.

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