As the weather heats up in the western hemisphere, the temperatures are not the only thing increasing…
In Pharmaland, the oncology space traditionally sees either interesting new data published or a spate of post American Society of Clinical Oncology (ASCO) filings. The summer doldrums often give way to a faster pace in the fall.
One thing we have been following over the last two years is the T790M race to market in EGFR mutant lung cancer. Clovis Oncology announced last week that they have begun their rolling NDA submission for rociletinib (CO–1686), but what about their keen rival, AstraZeneca with AZD9291?
The company presented new data for AZD9291 jn the EGFR mutant lung cancer upfront setting, but no formal announcement was made about the regulatory status.
There are some potentially interesting new developments to report here, though.
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The potential of Clovis Oncology’s EGFR inhibitor rociletinib (formerly CO-1686) to treat T790M negative non-small cell lung cancer (NSCLC) was one of the interesting talking points of the recent JP Morgan Healthcare conference in San Francisco (JPM15).
At the JP Morgan Healthcare Conference (JPM15), Clovis presented updated data that shows some efficacy in those NSCLC patients who no longer respond to an EGFR inhibitor, but don’t have a T790M mutation (T790M negative). Both AstraZeneca’s competitor compound, AZD9291, and rociletinib shown considerable activity in those EFGR resistant patients who develop a T790M mutation and it’s likely they will both soon be approved in this indication, based on the encouraging data seen to date.
However, what is surprising and could be a key differentiation factor for Clovis, is if there is sufficient efficacy in T790M negative patients for use of the drug in this indication.
In this post, we discuss the potential of rociletinib in NSCLC T790M negative patients, whether thought leaders might use the drug in this indication, and delve deeper into the science behind the efficacy seen.
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We hope that everyone had a relaxing holiday break and now it’s time to get back to work. Tomorrow I will review some more of my thoughts in the immuno-oncology space, since that area had a tremendous amount of progress in San Diego with lots of new ideas to process and summarise.
In the meantime, a few people have written in and asked about what was happening with overcoming resistance in various tumour types, was there anything new to say in that space that was in addition to the the detailed previews we covered before the conference?
Actually, there was a quite a few posters and presentations that caught my eye, so I thought this would be a good idea to review them here:
Lung Cancer: HER2, VEGF, T790M, EGFR, erlotinib, gefitinib, trastuzumab, bevacizumab, CO-1686, AZD9291
Prostate Cancer: mTOR, PI3K, Androgen Receptor, enzalutamide, abiraterone, CC214–2, ARN–509, BET Bromodomian inhibition, ODM–201, GDC–0980, GDC-0068, PF–04691502, BKM120, BEZ235
For the third part of the series on the AACR Previews, I wanted to switch directions and take a broad look at five completely different approaches in cancer research that we haven’t discussed on Biotech Strategy before and look at how they are doing and which ones might be promising going forward. Some of these scientific developments could potentially impact existing compounds in development.
Companies mentioned: Exelixis, Roche/Genentech, GSK, Clovis, AstraZeneca, Oncoethix
Compounds discussed: cobimetinib, DEDN6526A, ipatasertib, dabrafenib, trametinib, OTX015, JQ1, CO–1686, AZD9291
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Sydney – 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?
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.