This week certainly turned out to be a defining tale of two drugs with a chequered history…
First off, the FDA approved AbbVie/Genentech’s venetoclax, now known as Venclexta, in a subset of CLL patients with 17p deletions. These patients have a historically poor prognosis and the approval goes some way to addressing the high unmet medical need.
Secondly, another biotech company, Clovis Oncology, got slammed by ODAC with a 12-1 vote to wait for phase 3 data from the TIGER-3 trial for rociletinib to better determine the efficacy:safety benefit profile.
For a long while it seemed that AbbVie had nothing but toil and trouble over the tumour lysis syndrome (TLS) issues giving them some significant challenges to overcome, while Clovis were one of the new darlings of Wall Street.
In the final dash to the market, the tables were turned almost at the 11th hour and fortunes stunningly reversed. Yet a mere eighteen months ago, few industry watchers would have predicted the difference in outcomes.
In our latest AACR Preview series, we take a look at Bcl2 inhibition and where some of the emerging opportunities might lie based on new preclinical research that is being presented here in New Orleans this weekend. It makes for interesting reading.
While one tiger is licking its wounds, another is smacking it chops at what the future might hold for new combination approaches; how the tails have literally turned.
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ASH 2015 LBA Session
The annual meeting of the American Society of Hematology (ASH) has a few quirks compared to other meetings. One of these is that all the “Late Breakers” are presented together on the last morning of the meeting.
It’s a rather unfortunate time given many have already headed back to their busy clinics or left for SABCS in San Antonio and ‘late breakers’ by definition, often offer new data that’s really noteworthy.
The result can also be a bit of a hodgepodge session that you have sit to listen through to get to those presentations you really want to hear.
At ASH this year there were two late breakers on new treatment options for CLL patients with a 17p deletion (Del17p). This is a pretty challenging group to treat. Although ibrutinib is indicated for this patient group, many sadly relapse. There’s an unmet medical need for new treatment options. At ASH we heard data for idelalisib (PI3K-delta) and venetoclax (Bcl2).
After the session, I briefly spoke with Dr Kanti Rai (New York) for his reaction to the data. Dr Rai (pictured below) received the 2014 Wallace H. Coulter Award for Lifetime Achievement in Hematology.
Dr Kanti Rai receives 2014 ASH Lifetime Achievement Award
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In the last of our American Society of Hematology (ASH) 2015 annual meeting previews, we take a broad look at a host of intriguing abstracts in a variety of different topics that haven’t been covered in the rest of the series.
We also take a look a drug that has had a chequered history in the past, namely venetoclax, from the folks at AbbVie and Genentech. Is this a dud destined for dog drug heaven, or will it make a roaring comeback, breathing fresh life into hematologic malignancies such as chronic and acute leukemias, lymphomas and even multiple myeloma?
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The 2015 annual meeting of the American Society of Hematology (ASH) (Twitter #ASH15) in Orlando has a bumper crop of interesting data.
ASH is one of the my favourite meetings on our conference calendar. I’ve been attending for many years, starting with when I was a commercial account manager for Hematology, Immunology, Transplantation and Oncology in the UK, then at Novartis in the US, when I was part of the team that brought Gleevec to market.
Hematologists make for an interesting group of people to talk to! They are very focused on the science behind a disease and how translational research can move the needle forward and generate better outcomes for their patients.
As part of our continuing preview of #ASH15, I’ve taken a quick look at the late-breaking abstracts that were released today. We will have more in-depth coverage after we’ve heard the data presented in the 7.30-9.30 am session on Tuesday December 8.
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If you’re not already a subscriber, but what to know “What’s hot at ASH15?” then you should purchase access. Additional ASH previews are already planned. By the time you’ve read them, you should “hit the ground running” in Orlando.
As Warren Buffett famously said, “Price is what you pay. Value is what you get.” I couldnt agree more. We have subscribers who just purchase our ASH coverage every year, so do “check it out“ if you haven’t done so already.
Last month’s Biotech Strategy mailbag – where we answer questions from subscribers – turned out to be rather controversial with strong feelings running in several camps on Puma Biotech’s neratinib in breast cancer.
This time around we have a bunch of questions on completely different topics and compounds to cover:
- BRAF plus MEK and/or immunotherapy in BRAFV600 metastatic melanoma
- Immunogen’s IMGN853 – now known as mirvetuximab soravtansine – in platinum resistant ovarian cancer
- AbbVie/Genentech’s ABT–199/GDC–0199 venetoclax
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A couple of years ago we had a lot of fun here on BSB following the progress of ibrutinib (Imbruvica), obinutuzumab (Gazyva), and idelalisib (Zydelig) in CLL and indolent NHL. It seemed back then that the stunning trio were the hot topics for some time at ASCO and ASH meetings. Exciting times! All three target different entities (BTK, anti-CD20 and PI3K-delta) and made it past the tape to market, with Gazyva leading, Imbruvica a close second and Zydelig a slightly more distant third. I was reminded of the race again over the last week or so as the 4Q earnings were announced, with Pharmacyclics reporting almost $500M for Imbruvica last year and estimating sales to hit $1B in 2015. In contrast, Zydelig revenues for 2014 were $23M, reflective of their much later market entry in the US.
Still, that was a pretty impressive set of drugs all in development at the same time.
Two other agents we also reported on regularly were Infinity’s IPI-145, a PI3K delta-gamma inhibitor, and ABT-199/GDC-0199 (now known as venetoclax). I haven’t heard much about the former of late, but after a few missteps, the next big question to consider is whether venetoclax is coming back strongly or destined for dog drug heaven?
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San Francisco – Acute Myeloid Leukemia (AML) is largely a disease of the elderly since it is uncommon before the age of 45. It generally has a much poorer prognosis compared to other leukemias such as CML and even ALL. There are two main treatment options – high chemotherapy (ara-C is the main bedrock) or a stem cell transplant in those patients who are considered eligible. With the average age at diagnosis being ~66yo, many patients may be elderly and frail, making a SCT not a viable option.
Ara-C (cytarabine) has been around for many years and despite numerous clinical trials, it has yet to be displaced. There’s plenty of room for improvement though, and a high unmet medical need still exists. The good news is that despite the challenge of finding a highly effective yet well tolerated therapy, there’s a lot of R&D activity in this space.
In this preview of the data to be presented at the American Society of Hematology (ASH) annual meeting in San Francisco, I highlight my top 10 AML abstracts that are worth checking out.
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One of the things I most enjoy in cancer research is hearing wonderful patient stories from oncologists who are at the coal face of clinical trials. They get to deal with death and dying every day and like those in Pharma R&D, also live for the successes, the drugs that make it through pipeline despite great odds against them and make a meaningful impact on the daily lives of ordinary people.
We’ve all heard topline data presented at medical conferences around the world, but what the summary data can’t tell you is how a drug can impact people in ways that are clinically meaningful yet are more obtuse to capture in the aggregate. This is why case studies at CME sessions are increasingly popular, because they add value and context to common issues in a way that a Kaplan-Meier curve can never do.
With the flurry of recent US and EU approvals for obinutuzumab (Gazyva), ibrutinib (Imbruvica) and the newest kid on the block, idelalisib (Zydelig), in CLL and indolent lymphomas, I wanted to take a look at these drugs from a different perspective.
A reader wrote in asking which of these new agents would emerge the winner and why?
Today’s post therefore offers some thoughts on the emerging CLL landscape now that we are shifting from new product development to the marketplace.
Drugs mentioned: Gazyva, Imbruvica, Zydelig, ABT–199/GDC–0199, Arzerra, IPI–145, CTL–019
Companies: Roche/Genentech, J&J/Pharmacyclics, Gilead, GSK, Infinity, Novartis
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Previously, we discussed the role of new agents being developed for aggressive non-Hodgkins lymphoma (NHL) with Dr Nancy Valente of Genentech, particularly how their antibody drug conjugates (ADCs) could have a potential role to play in revolutionizing treatment for patients with an otherwise poor prognosis.
The second half of the interview from ASCO 2014 focuses on more indolent disease, namely chronic lymphocytic leukemia (CLL) and the role of their novel therapeutics obinutuzumab (Gazyva) and ABT–199/GDC–0199.
We’ve heard a lot of positive data about the anti-CD20 monoclonal antibody, obinutuzumab, but the Bcl2 inhibitor undergoing co-development with AbbVie has had a bit of a chequered history to date. There is no doubt that ABT–199/GDC-0199 is highly potent, while lacking the severe myelosuppressive effects (thrombocytopenia) of its predecessor, navitoclax — which can be both a blessing and a curse — as the phase I single agent investigators discovered recently when severe tumour lysis lead to two sudden patient deaths.
It is important to address these issues expeditiously in a safe and rational way to ensure patient safety for those who enroll in both current and future trials. This is a critical issue we discussed at length with Dr Valente and how the company has been handling it.
At the AACR Molecular Targets meeting last November, many readers will remember that we learned about Genentech’s research plans for combinations with GDC–0199 in CLL and NHL in an interview with one of the scientists for that program, Dr Deepak Sampath.
Today, it’s time to look at where and how this exciting agent might impact CLL. Obviously, both CLL and NHL have commonalties and overlap, since they are both B cell disorders, so often what works in one disease often works well in the other too, as rituximab has clearly demonstrated.
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Chronic lymphocytic leukemia (CLL) and indolent non-Hodgkins Lymphoma (iNHL) have received significant attention over the last two years. More exciting new therapies than ever before – with multiple different mechanisms of action – have either recently come to market or are in development. There is an ongoing revolution in the CLL landscape and treatment of the disease, which above all else is good news for patients! As part of our ongoing longitudinal coverage, there’s a lot to discuss and catch up on in Chicago at the annual meeting of the American Society of Clinical Oncology (ASCO).
What’s different at ASCO this year?
Basically, a LOT more data – it’s almost a tsunami considering this is ASCO and not the American Society of Hematology (ASH) annual meeting! I am excited to see that there is so much new data at ASCO. Yesterday, we highlighted 3 key sessions for multiple myeloma. For CLL/SLL and iNHL there are 9 – to put the sheer breadth of data and studies in context. This includes ongoing phase 1-3 trials, as well as new randomised controlled phase 3 studies that are now open and enrolling patients. If successful, some of these latter studies will play a crucial part in future registration packages to the Health Authorities. In the past, we have talked extensively about CD19 antibodies such as obinutuzumab (Gazyva) and BTK inhibitors such as ibrutinib (Imbruvica). Both of these drugs are now approved and available in the US.
Other therapies in development we have covered in the past have included PI3K inhibitors delta (idelalisib) and delta, gamma (IPI-145), as well as Bcl2 inhibitors (ABT-199 / GDC-0199), SYK inhibitors (fostamatinib and GS-9973), and CAR T cell therapies such as CTL019. To find out more about our insights on the ever-changing CLL landscape, you can sign in or sign up below.