Biotech Strategy Blog

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

Posts tagged ‘palbociclib’

Stormy waters – Oncology R&D is a fine line between success and over the edge sometimes!

BSB Reader Mailbag – With the FDA approval of lurbinectedin on Monday and two very different recent announcements regarding adjuvant therapy readouts for CDK4/6 inhibitors, we received a bunch of BSB reader questions on both topics.

It’s been a while since we dived into the mailbag in a busy conference season, so this is a great time to reflect on some broader thoughts in oncology R&D for context.

Here, we look at two key aspects…

  • Am I enthused about the lurbinectedin data or not?
  • What half dozen factors could we be thinking about when considering CDK4/6 inhibitors in adjuvant HR+/HER2- breast cancer in order to decide if one is better than the other or does luck play a part?

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This weekend in the oncology conference calendar saw the ESMO Breast meeting take place.

The event was originally planned as a live event in Berlin – sadly with the pandemic it ended up as a virtual meeting on Central European time, yet you can still imagine the Berlin bear welcoming everyone regardless of format!

This is a good time to take off we we left off last week with our SERD landscape review since there was some new clinical data presented in this niche, as well as segue to the ASCO meeting on Friday where other companies will also be showcasing their early data.

Aside from SERDs, there were plenty of other highlights and commentary to consider in advanced breast cancer.

Here we explore some of the findings and offer some context for at least one commercial showdown…

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Oncology R&D is very much a tale of two cities. At one end you have all big pharmas and biotechs with significant resources in the form of very large budgets, (hopefully) an extensive pipeline, plus many hands on deck to efficiently spread the workload, while at the other end you have what I call the ‘baby’ biotechs with completely the opposite situation coupled with a much greater need for prudence in how those scarcer resources are managed.

A failed drug development may not affect big pharmas very much, it’s written in to the strategic plans after all, and a 90% failure rate is very much de rigeur so you’re looking for the rare gems that will shine and carry the rest. In small biotechland, such inherent risks are much more prominent – and drastic – because a failed program can wipe out the stock overnight such that future endeavours to raise money are greatly hampered, putting the very life of the company at risk of not only delisting (if publicly traded) from stock exchanges such as NASDAQ, but also the ultimate doom.

The constraint that both bookends have in common, however, is familiar to many readers – how to get the best shots on goal given the time, energy, and resources available?

At BSB we don’t write just about big Pharma – we also try to highlight the roller coaster experienced at the other end of the spectrum and showcase some cool science in the process. Given our interest in stapled proteins as well as the various challenges associated with both tumour suppressors and MDM2, it seemed like a good idea to catch up with the folks at Aileron Therapeutics (NASDAQ: ALRN) and learn more about their progress since they combine all three elements in one go…. it’s time for some gems from the ESMO19 poster hall.

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It’s time to talk about new developments in breast cancer.

@3NT with Dr Dennis Slamon at ESMO19

This week we will be featuring thought leader interviews with two breast cancer specialists as we look at new data in different subsets of this disease, in both early and metastatic settings.

We like to ring the changes with invited guests on BSB who comment on trial results and offer broader perspectives on their specialist field as well.

One expert is someone neither of us has ever interviewed before, while the other returns for an update on an early trial that is showing promise. Both interviews were conducted under embargo ahead of their presentations in Barcelona.

One of the myriad of challenges in oncology R&D is the tendency to begin exploration in the most advanced form of the disease with monotherapy to determine single agent activity and then work up to earlier lines of therapy with combinations evolving over time.

While it is always good to see proof that people are living longer with particular approaches, there is a real need to keep one’s eyes out on the horizon for new developments that may extend overall survival further.

What should those regimens look like and what are rational choices based on the underlying biology of the disease rather than being explored because that’s what a particular sponsor happens to have in their pipeline? We were delighted to have the opportunity for a much broader discussion some of these opportunities with today’s key opinion leader, Dr Dennis Slamon of UCLA, who presented data in an ESMO Presidential symposium and also talked about other topics in breast cancer research with BSB.

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The 2019 annual meeting of the American Society of Clinical Oncology (Twitter #ASCO19) is now in full swing, and we’re kicking off our on-site meeting coverage with a review of the some of the highlights of Friday here in Chicago.

In today’s Daily Highlights we offer seven areas of interest and offer commentary on the insights gleaned from the data that is rolling out so far…

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It’s one of those truly crazy busy times of the year with no less than three cancer conferences going on this week alone in different cities and time zones. I’ve also been busy scheduling and conducting phone interviews for these events.  More than once have I dialled the wrong number or access code or got briefly confused by time zone changes (CT and CEST?!) and misread the interview at the wrong time… and was that 4.30pm ET or CT?

River Walk, San Antonio, Texas

One of those… If it’s Tuesday it must be Belgium moments to be sure.

Thankfully, everyone has been very thoughtful and helpful and I haven’t managed to get the expert names incorrect (yet)!

Today, I want to take a break from the ASH17 coverage and switch horses from hematologic malignancies to breast cancer and from Atlanta to San Antonio, as there is some important new data emerging from the Lone Star state.

In particular, one of the top posts of 2016 on BSB was on CDK4/6 inhibitors so it’s time for an update on this and some other key studies!

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The White House in spring, Washington DC

With spring in the air and the clock rapidly running down on the annual meeting of the American Association for Cancer Research (AACR) in Washington DC in just two weeks time, it’s time to take a look at the seventh topic in our Preview series.

What’s hot on deck to day?

With increasing competition in the metastatic breast cancer space, particularly in HR+ HER2- disease, it’s time to explore key issues around CDK4/6 inhibitors as there’s a lot going on here, including some important presentations ahead.

A road map of what to expect and what to watch out for is often valuable if you want to avoid surprises.

We also examine key issues the companies here are facing as well as highlighting emerging scientific and clinical data of note on several relevant fronts.

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Post 2016 US Election, we move on and get back to business with an in-depth review of some new science and clinical data.

ash-2015Yes, it’s time for another Bushidō – “Way of the Warrior” – guide to the key ASH abstracts!

Here we focus on acute myeloid leukemia (AML), a difficult and challenging disease to treat with a high unmet medical need for new effective therapies.

In this Preview we look at key companies in the AML space, as well as a look at what’s happening in classic targets and also some new ones that are receiving notable attention, both preclinically and also in the clinic.

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There was a time when it seemed that all the good news emerging in cancer research was on breast cancer, that is clearly no longer true as other tumour types have seen some leaps and bounds with different modalities, including areas previously thought to be a graveyard for big Pharma, such as metastatic melanoma, for example.


New Dawn at the Houses of Parliament

That said, after the excellent developments in hormone-sensitive disease and the identification of the HER2 oncogene, we now have CDK4/6 as a validated target in metastatic breast cancer.

Pfizer’s palbociclib (Ibrance) lead the way, with two approvals in previously untreated and relapsed ER+ HER2- advanced breast cancer. Two other companies in this field are Novartis with ribociclib and Lilly with abemaciclib. Data is being presented on all three therapies at ESMO this year.

In addition, there are some other abstracts of note that are well worth discussing.

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If you had told me several weeks ago that we would write over 28 posts on #AACR16 and become very interested in mouse models, then most likely I would have laughed out loud and told you not to be so ridiculous!  Here we are with the 29th one and, another, on the bromododomain landscape yet to go.  Such was the vast richness of data and concepts being discussed or presented in New Orleans for those who chose to look.

Today, I want to start the segue from AACR to ASCO coverage.

Nawlins MGRAS FIOne way to do that is through the second part of the Gems from the Post Hall series. This latest one looks at a range of intriguing new targeted therapies and novel targets that are emerging, including a pharma company with a particularly interesting early pipeline.

Several pharma companies presented interesting data on their very early compounds currently in development, plus I noticed a trend for a new class of targeted therapies to emerge, MNK inhibitors, which we will also discuss.

Companies mentioned: Bayer, Orion Pharma, Lilly, Novartis, Pfizer, Agios.

Targets mentioned: PI3K, CDK, Akt, TWEAK, FGFR, BUB1, IDH1, SMYD2, MNK

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