Biotech Strategy Blog

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

Posts tagged ‘Lilly’

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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The 2016 Congress of the European Society for Medical Oncology (ESMO) is fast approaching. It takes place next month from October 7th to 11th and we will be on site covering the meeting for Biotech Strategy Blog. We’re looking forward to a great meeting!

ESMO 2016 CongressIf you are sitting on the fence as to whether you should go to Copenhagen, then hopefully our series of Previews will help you decide.

Be warned that accommodation is in already in short supply and ESMO are now putting people up across the Oresund bridge in Malmo, Sweden.

The Congress App has a lot of useful information and is well worth downloading, if you haven’t done so already.

Last week many of the late breaking abstract (LBA) titles were announced, although there are still some placeholders. While we won’t know the actual late-breaking data until the meeting, the LBA titles offer insights into what will be presented in Copenhagen.

In the second in our ESMO 2016 Preview series, we’re highlighting the lung cancer late breakers that we’re looking forward to hearing, providing some background on why they may be of interest, and a look at how some of subset landscapes may be a-changing in the future.

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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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San Francisco JPM16 Day 2It’s Tuesday at the 2016 JP Morgan Healthcare conference in San Francisco (Twitter #JPM16).

Each day of #JPM16 we’re doing a rolling blog post which we’re updating throughout the day with commentary and insights on the company presentations we’re covering.

While we’re not giving a blow-by-blow account, many companies have the slides readily available, we will be commenting on noteworthy news, and what we learn about corporate strategy going into 2016.

For those of you who like to catch up with the final summary of each day’s highlights, you can read yesterday’s Day 1 synopsis here and our interview with Seattle Genetics CEO, Clay Siegall here.

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Sarcoma is something we call one disease but actually represents 50-70 different histologies, which poses challenges for drug development.  Not only do you have to identify what’s the unique target, but it’s hard to accrue patients into trials, when a major center may only see a few of each sub-type.

Soft tissue sarcoma is an area of unmet medical need, and one I have been interested in since launching Gleevec in GIST (way back when) when I was fortunate to get to know many of the leading sarcoma experts.

Dr George Demetri

George D. Demetri, MD. Photo Credit: DFCI

One of these is Dr George Demetri, who is Director, Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute and a Professor of Medicine at Harvard Medical School.

At the recent European Cancer Congress in Vienna, I had the privilege to talk with Dr Demetri about some of the latest research in soft tissue sarcoma.

We spoke about cancer immunotherapy, new small molecules and monoclonal antibodies, and the potential of targeting the epigenetic machinery.

A lot of what Dr Demetri is doing is currently “under the radar” and while he didn’t give any secrets away, he did give some sense of where some breakthroughs may occur in the not too distant future.  He also talked about how sarcomas with a specific target can be used for proof of concept clinical trials of novel agents.

Given the pressure that many companies are under to speed up their path to market strategies, accelerated approval in a rare tumour subset is one approach that can be considered.

It’s an exciting time in the field with the potential for several agents in development to move the needle and make a difference. I hope you enjoy this post, it was a real pleasure to talk with Dr Demetri again.

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The next few weeks will see quite a lot of activity here on Biotech Strategy Blog with the segue from Miami Breast Cancer Conference to the World Lung Conference in Geneva and then onto the annual AACR meeting in San Diego.

Over the last year, we’ve seen a lot of attention focused on immuno-oncology, but very little of the data has emerged yet in breast cancer. Instead, we’ve seen a new approval for pertuzumab (Perjeta) in neoadjuvant disease, based on pCR. You can read more about new developments in targeting HER2 in neoadjuvant breast cancer in the last post.

One area that has generated a lot of interest in metastatic breast cancer is CDK inhibition, whether that be the potential for targeting 1 and 2 in triple negative disease, or targeting 4 and 6, in ER positive situations, for example. Some inhibitors are more specific (Pfizer’s palbociclib and Novartis’s LEE011 target CDK4/6), whereas others hit a broader spectrum such as Merck’s dinaciclib, which inhibits CDK1/2/5/9. The challenge with pan inhibitors is that if the target is doesn’t matter to the tumour then there is potential for unwanted off-target side effects.

Last month Pfizer announced that the topline phase II results from the PALOMA –1 trial with their CDK4/6 inhibitor, palbociclib, were positive – no doubt we will see an ODAC meeting soon to discuss the FDA application and possible accelerated approval. The company received Breakthrough Therapy Designation in April last year and given the survival curves from the phase II study that have previously been presented at SABCS, I think they make a very good case for early approval.

Recall that the interim analysis demonstrated very compelling median progression free survival (PFS) of 26.1 months for palbociclib when combined with letrozole compared to only 7.5 months with letrozole alone in women who were post-menopausal with newly diagnosed ER+ HER2- breast cancer. obviously the final results will be important in influencing any FDA decision, but by whatever yardstick you use, those were very impressive data indeed.

The phase III trials, PALOMA–2 and PALOMA–3, are already open and enrolling patients.

Bill Sellers, Source: NIBR

Bill Sellers, Source: NIBR

Other companies also have CDK4/6 inhibitors in clinical development, including Lilly and Novartis.

Today’s post focuses on progress in targeting CDK4/6, including highlights from an interview with William Sellers MD, PhD from the Novartis Institute of Biomedical Research (NIBR).

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The 2014 ASCO Gastrointestinal (GI) Cancer Symposium takes place in San Francisco from Jan 16-18 and is the second meeting in this year’s oncology conference calendar. GI cancers include oesophageal, gastric, colorectal and pancreatic cancers, as well as hepatocarcinoma or HCC (liver).

You can follow any tweets from ASCO GI using the hashtag #GI14.

This year, the topics that most caught my eye in the program were pancreatic and gastric cancers.

This post provides insights on the key studies that looked interesting to me at this event, based on the schedule available.  The abstracts will be available on January 14th and can be accessed here.

Companies mentioned: Celgene, Lilly, Roche/Genentech, Aduro Biotech
Drugs mentioned:  Abraxane, Gemzar, ramucirumab, Avastin, Herceptin, GVAX

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Whew, having just finished the American Society of Hematology (ASH) meeting, we run on to the breast cancer symposium in San Antonio (SABCS), making for a very busy week of data deluge!  Our Post ASH analysis will also run concurrently for a few days.

There are also a number of interesting areas to look out for in terms of interesting breast cancer developments.

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Companies: Roche, GSK, AbbVie, AstraZeneca, Novartis, Lilly

Drugs: Herceptin, Avastin, Perjeta, Tykerb, veliparib, olaparib, BKM120, ramucirumab, PD-1, PD-L1

Here’s a quick preview of some of the landmark data emerging from this conference, some positive, some negative.

Following on from yesterday’s post about learnings from the Boston AACR-NCI-EORTC conference in immuno-oncology, today’s post focuses on learnings from non-immune R&D, namely monoclonal antibodies and TKIs.

We know that cancer is a very complex topic and that adaptive resistance is increasingly a huge focus, but where are the new developments in this area and what can we learn from them in order to improve outcomes?

Another key area to consider is therapeutic index, that is are we shutting down enough of an oncogenic target’s activity in order to ensure efficacy? We’ve seen this in the anti-angiogenesis field, for example, where many VEGF inhibitors failed before bevacizumab (Avastin) finally cracked the nut in colorectal cancer and shifted the needle in terms of improving overall survival. We are now seeing this happen in other areas too, which will be covered below.

Last week on January 20, 2011, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee decided not to recommend approval of Lilly’s Amyvid™ (florbetapir) in a 13:3 vote.  Florbetapir is an imaging agent used with Positron Emission Tomography (PET) to show accumulation of beta-amyloid plaque in the brain. I previously wrote about Lilly’s acquisition of Avid Radiopharmaceuticals for florbetapir on this blog.

This imaging approach aids in the early detection of Alzheimer’s disease, as a negative scan, not showing any beta-amyloid plaque, would rule out Alzheimer’s disease.  Given that it is currently, hard to distinguish age related memory less and different types of dementia, diagnostic imaging tools have an important role to play.

The FDA advisory committee’s decision would probably have come as a surprise to Lilly, since the clinical trial data showed clear efficacy and no safety concerns.  While the committee rejected immediate approval, they did recommend approval (16:0), conditional on a training program to show that radiologists and readers of the scans could be accurate and consistent in their image interpretation. The FDA is not bound by the Committee’s recommendations but is required to take them into consideration when deciding whether to grant approval.

Imaging is becoming increasingly important in clinical trial design. In therapeutic areas such as osteoporosis, rheumatoid arthritis and oncology, imaging end points are often surrogates for drug efficacy.

The challenge that emerging biotechnology companies face in linking imaging to drug use, is the variability of readers outside a controlled clinical trial environment where images may be read centrally.  Standardization of image acquisition and reading needs to take place, so that a radiologist in different hospitals can come up with the same findings.  Those involved with imaging clinical trials know how hard this can be, even within the controlled clinical trial setting.

The recommendation of the FDA advisory committee that Lilly needs to put in place a training program to show accuracy and consistency of readers is a valid concern and one that all biotechnology companies and pharmaceutical companies should take note of when developing imaging agents.

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