Biotech Strategy Blog

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

Posts tagged ‘EGFR T790M’

After a long lull on the targeted therapies front – outside of EGFR T790M in lung cancer – this year’s ASCO has plenty to be cheerful about with new data across multiple tumour types.  We can’t cover them all here, but more will be discussed in the Daily Live Blogs starting on Saturday.

Which drugs are going to be in roaring back after a quiet period?  Which ones will be having a more muted meeting?

ASCO16 Chicago 4For those of you who are working in the targeting therapy world, take heart, there is a future beyond cancer immunotherapy; it is not the universal panacea and will likely not cure every cancer, at least for now.

There’s still a market opportunity for targeted therapies in cancer, and as we mentioned in yesterday’s ASCO Preview, there is also potential for the combination of targeted therapies with immunotherapies, so long as the combined toxicity is manageable and doesn’t outweigh the benefits.

In this post we’re looking at a selection of targeted therapies in a variety of tumour types. There’s a lot to choose from at ASCO this year.

Here’s a few we think are worth highlighting upfront.

Subscribers can log-in to learn more or you can click on the Blue Box below to sign-up and become a member of the burgeoning BSB Community who appreciate the value of education, information and, even occasionally, infotainment…

It’s Friday 13th, a day often feared by the superstitious, but for AstraZeneca it certainly portended good news with the FDA approval of AZD9291 or osimertinib (now Tagrisso) in EGFR T790M mutation-positive lung cancer – three months ahead of the PDUFA date. Jonathan Rockoff, a reporter at the WSJ, was the first to announce it in my Twitter stream:

Tagrisso 80mg

Tagrisso 80 mg. Picture credit: AstraZeneca

The FDA announcement for Tagrisso (generic name is osimertinib) can also be found here and the actual label here.

Note that it is now available under accelerated approval, based on tumor response rate and duration of response. This means that phase III confirmatory trials, including survival data will be needed for full approval.

As part of our ongoing series on the T790M niche, this is also a timely opportunity to catch up with the latest data that was presented earlier this month at the AACR-NCI-EORTC Cancer Therapeutics and Molecular Targets meeting in Boston.

Subscribers can log in or you can sign up below.

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.

You can login or sign up below to read why I think CO-1686 was not a loser at ASCO 2014.

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.

4 Comments

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.

error: Content is protected !!