Biotech Strategy Blog

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

Posts tagged ‘NSCLC market’

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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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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