Biotech Strategy Blog

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

Posts tagged ‘AZD9291 NSCLC’

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.

Subscribers to premium content can read more below:

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.


The 2013 Molecular Targets and Cancer Therapeutics Conference (twitter #targets13) takes place in Boston from October 19-23 at the Hynes Convention Center. It’s a “must attend” meeting for anyone with an interest in cancer drug development and I’m really looking forward it. Boston is an exciting place for cancer research!

Molecular Targets Meeting AppJointly organized by the American Association for Cancer Research (AACR), European Organization for Research and Treatment of Cancer (EORTC) and National Cancer Institute (NCI), it alternates each year between Europe the United States.

The molecular targets meeting program and abstracts are now available online. There’s also a meeting App that’s well worth downloading if you plan to be there.

As for what’s interesting at the meeting – the three media briefings give a flavor of what to expect:

Sunday, Oct. 20, 10 a.m. “Emerging Therapeutics,” including research on investigational drugs AZD9291 and PF-06463922, which have the potential to overcome drug resistance in some lung cancers.

Monday, Oct. 21, 9 a.m. “Overcoming Resistance and Hard-to-Treat Cancers,” including research on a new antibody-drug conjugate MLN0264 for pancreatic cancer and a new nanopharmaceutical CRLX101 for cancers resistant to antiangiogenic drugs.

Tuesday, October 22, 9 a.m. “Guiding Treatment for BRAF- and BRCA-related Cancers,” including updated data on the clinical benefit of the PARP inhibitor BMN 673 and a new diagnostic platform to rapidly identify BRAF mutations.

The AACR press team led by Jeremy Moore have done a good job of identifying some of the exciting new drugs in development.

Readers of blog premium content have already read about the potential of AZD9291 in T790M resistant lung cancer from ECCO 2013 in Amsterdam.  While it looks like the ECCO late-breaker did steal some of the thunder from the molecular targets meeting, there’s going to be more granularity on the compound at AACR, and hopefully some updated clinical data.

There are three AZD9291 posters at the meeting, and I’ll be covering all of these while in Boston:

Sunday, Oct 20, 2013, 12:30 PM – 3:00 PM  A109: AZD9291: an irreversible, potent and selective third generation tyrosine kinase inhibitor (TKI) targeting EGFR activating (EGFRm+) and resistance (T790M) mutations in advanced lung adenocarcinoma.

Monday, Oct 21, 2013, 12:30 PM – 3:00 PM  B212: Integrating the pre-clinical pharmacokinetic, pharmacodynamics, and efficacy data for AZD9291, an oral, irreversible inhibitor of EGFR activating (EGFRm+) and resistant (EGFRm+/T790M) mutations and an active metabolite to predict the human pharmacokinetics and potential efficacious dose in patients.

Monday, Oct 21, 2013, 12:30 PM – 3:00 PM B94 Discovery of and first disclosure of the clinical candidate AZD9291, a potent and selective third-generation EGFR inhibitor of both activating and T790M resistant mutations that spares the wild type form of the receptor.

Another compound that I have been following with data at Molecular Targets is ABT-199/GDC-199.

You’ll find me in the poster halls every afternoon, so if you are going to be in Boston for Molecular Targets, I look forward to seeing you there!

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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