Biotech Strategy Blog

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

Posts tagged ‘abemaciclib’

A typical scene from ESMO 2019

Not in Madrid – Is it really only a year ago many of us were frantically dashing around at ESMO last year navigating crowded corridors, long queues for coffee, hunting down the last empty seat in jam packed halls, not to mention feeling the anticipation build for key data being presented in the Presidential sessions?

There are undoubtedly many advantages to virtual digital meetings, aside from the broader access for more people it provides and being able to see the slides unimpeded, yet it must be confessed the things I miss the most are the social interactions and catching up with people and their lives, however brief a moment it may be amongst the hurly burly of 20,000 other souls.

The cultural things we take for granted are often the very essence of what we miss most when they’re no longer obtainable.

Who truly would have guessed our world could be completely upended by the unexpected events of a global pandemic since then? In some ways, it has changed our perception of both time and space.

We have also seen some surprising changes in the fortunes of various clinical trials; some completely rational and predictable, others quite the opposite, as we learned yesterday in a very topsy turvy kind of way.

It’s time to discuss and review the highlights – and lowlights – from ESMO20 Sunday in part 2 of our daily coverage…

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Not in Madrid – with the global pandemic continuing to exert a significant effect on the cancer conference season, the annual meetings continue apace virtually.

Plaza de Cibeles, Madrid

For this year’s ESMO meeting we have already covered immunotherapies, both early and late stage pipeline highlights and now it’s time to explore what to watch out for over the weekend on the early to mid stage targeted therapy front.

The good news is there is some potentially practice changing data being presented, as well as some novel approaches in preclinical development emerging. These should be hitting the clinic in the near to medium term future.  On the other extreme is the more common problem whereby a few agents are showing signs of not holding up to their early promise/hype.

Let’s now take a look at what we can learn in the fourth and final ESMO Preview for 2020…

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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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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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Greetings from continental Europe!

ESMO Madrid Conference Center

We have a LOT of data to discuss today from ESMO and have also included an interview with one expert that was conducted under embargo on an important topic.

Of course, the usual in-depth analyses on new targets and early compounds in development will duly follow in the post-meeting output, but there’s plenty of practice changing data to consider and also some results that may trigger alternative thinking from where we are now.

We also received questions from BSB readers on certain trials and some of these are answered in today’s update on the road…

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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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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-houses-of-parliament

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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Yesterday, Lilly and Boehringer Ingelheim announced a clinical trial collaboration in metastatic breast cancer with the CDK4/6 inhibitor, abemaciclib, and the IGF antibody, BI 836845. The goal of the phase Ib study is to evaluate potential of combination therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer (mBC).

Braving the ASCO 2016 Poster Hall

Braving the ASCO 2016 Poster Hall

A couple of BSB readers wasted no time and wrote in asking what we thought of this development, so this presents an excellent opportunity to turn the spotlight on combining targeted therapies in a rational fashion, especially as there was data presented on these agents at the recent ASCO annual meeting.

There are ceratinly a number of important considerations to explore with this type of approach.

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