Biotech Strategy Blog

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

Posts tagged ‘ibrutinib’

After looking at one important poster yesterday on multiple myeloma, it’s time to explore other equally interesting targets in other tumour types.

Some years reflect the inertia that hit oncology R&D with a lot of old data rehashed or they can be flooded with many me-too compounds.  Not this year, there’s a lot to talk about and review… so much so that we may well have enough for three rounds of Gems from the Poster Halls, time permitting as ASCO is fast approaching!

Without much further ado, for round 1 we have explored eight posters spanning four companies with a variety of different targets including chemotherapy, targeted therapies and immunotherapies.  I will say though, that the lines are being blurred as all of these modalities can impact the immune system, sometimes in unexpected ways.

What’s in store for today?  A focus on biotech companies doing intriguing cancer research.

Companies mentioned: Infinity, Innate, Incyte, Agenus

ASH Exhibit HallIn recent years, there’s been a lot of progress in the treatment of chronic lymphocytic leukemia (CLL). New targeted therapies such as ibrutinib (Imbruvica) and idelalisib (Zydelig) have been approved and have helped extend the lives of patients with this disease further. However, there still remains a need for new treatment options.

Several new drugs are on the horizon for CLL.  At ASH there were a number of presentations for venetoclax, formerly known as ABT-199/GDC-0199, it’s a BCL-2 inhibitor, which is being co-developed by AbbVie and Genentech.  We’ve written extensively about it on the blog.  One of the challenges with venetoclax is the potential for Tumor Lysis Syndrome (TLS) – we heard at ASH that starting a patient on the drug needs to be carefully managed and monitored, with high risk patients hospitalized.

Other new drugs on the longer term horizon for CLL include acalabrutinib (Acerta) and BGB-3111 (BeiGene), both next generation BTK inhibitors and potential competitive threats to ibrutinib. The CLL market is becoming interesting again!

At ASH 2015, I spoke with Ian W. Flinn, MD, PhD. Director, Blood Cancer Research Program at the Sarah Cannon Research Institute in Nashville, TN. At ASH, Dr Flinn presented data for a CLL trial of venetoclax combined with obinutuzumab, a CD20 targeted monoclonal antibody; data was obtained in both the upfront and relapsed/refractory setting.

In a wide ranging conversation, we talked about some of the data of note in Orlando, what the future direction is in CLL, and what to look forward to at ASH 2016.

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Aggressive lymphoma… the very phrase is enough to send chills down your spine!

ASH Annual MeetingIn the past, much of the focus at previous American Society of Hematology (ASH) meetings in this area has focused on the myriad of chemotherapy regimens and dose/schedule optimisations that followed in trying to boost patient outcomes.

This year, I’m pleased to say that things have quite a different flavour with numerous new therapeutics and promising combinations in development.

Some of these are inevitably hypothesis testing, while others will be up-levelling to large randomised controlled multi-centre trials.

As part of our ongoing preview series, we take a look at the different categories to watch out for beyond chemotherapy.  These include monoclonal antibodies, antibody drug conjugates, targeted therapies and yes, even immunotherapies.

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It’s time to answer some more subscriber questions. Several readers wrote in and asked about the anti-PD1 checkpoint data that was presented at the recent American Society of Hematology (ASH) meeting in classic Hodgkin’s lymphoma (cHL):

What did we think of it?

Well, for starters it was one of our highlights of the ASH 2014 conference (see quick write-up, open access), with an impressive 87% response rate for nivolumab in refractory cHL. Many of these patients had failed both autologous stem cell transplant and brentuximab (Adcetris), for which FDA granted breakthrough therapy designation.

ASH14 CHECKPOINTSOverall, I agreed with Ron Levy (Stanford) when he noted in the packed Special Session on Checkpoint inhibitors in Hematology that there were only 4 or 5 abstracts to actually discuss (he didn’t spend much time on the preliminary data) and that the results are still very early without seeing how good the durability will be.

As he observed in the session, which was standing room only, figuring out how best to integrate these new agents into clinical practice with other successful approaches will be most interesting.

That said, there are some new data that have emerged since ASH that are worthy of discussion in terms of potential future directions and how they could impact the checkpoint landscape in both hematologic malignancies and even solid tumours.

This is part of our ongoing immuno-oncology series on how we can manipulate T cells in creative ways to kill the cancer cells.  The findings discussed in this article are completely new and have not been discussed here before.

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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.

Zydelig_logoWith 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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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.

Chronic Lymphocytic Leukemia (CLL) was one of the hot topics at this year’s annual meeting of the American Society of Hematology (ASH), and a new CLL drug that caught my attention was the second-generation Bruton’s Tyrosine Kinase (BTK) inhibitor ONO-4059 from Ono Pharmaceuticals.

Professor Gilles Salles (Lyon, France) presented promising efficacy data from a phase 1 study of ONO-4059 in relapsed/refractory CLL and high risk CLL (#676).

Unfortunately after his presentation, Prof Salles declined my request for a quick interview citing a prior commitment with a large pharma company and subsequently failed to turn up for an agreed interview the next day. Talking about ONO-4059, at least with the media, did not appear to be a priority!

However, as a potential competitor to other BTK inhibitors in development such as ibrutinib (Pharmacyclics/JNJ) and CC-292 (Celgene/Avila) it’s worthy of a mention in the conference coverage and a quick post about the data presented.

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Now that the last of the 2013 cancer conference season is finally over, we’re going to run a couple of post meeting summaries this week from ASH as a few subscribers have asked for the Cliff Notes version of what was hot – or not in the context of the market.

New treatments for Chronic Lymphocytic Leukemia (CLL) was one of the hot topics at the recent annual meeting of the American Society of Hematology in New Orleans.

Hot on the heels of Roche’s recent FDA approval for Gazyva (obinutuzumab/GA101) in CLL, other companies in the race to market including:

  • Pharmacyclics and Johnson & Johnson (ibrutinib)
  • Gilead (idelalisib, GS-9973)
  • Infinity (IPI-145)
  • AbbVie and Roche (ABT-199/GDC-0199)
  • Novartis (CTL019).

Here’s my subjective and personal assessment of the winners and losers based on the data presented:

ASH for me always starts on a Saturday, as Friday is taken up with travel and a Super Friday corporate symposium, if any manage to catch our interest.

The start this year was somewhat disrupted by an ice storm that hit many southern states, causing considerable chaos for many ASH attendees – flights, hotels, bags, meetings, interviews, Ad Boards, investigator meetings, poster sessions and presentations etc.

I did enjoy the B cell malignancies CME session yesterday afternoon. Although it was sponsored by Gilead, it was well balanced and included discussion on FCR, ibrutinib, idelalisib, IPI-145, TGR-1202, ABT-199 and several earlier investigational compounds.

The highlight for me was Susan O’Brien’s thoughtful and philosophical talk on where are we going with CLL?

It’s an important question for physicians to start asking themselves with Gazyva approved in CLL, Imbruvica (ibrutinib) is pending in CLL and idelalisib expected to gain approval in 2014.

Originally, I was thinking of doing an in-depth review of lymphomas i.e. non-Hodgkin’s lymphoma (NHL), which involve 85% of lymphomas and Hodgkin’s lymphoma (HL), which take up the remaining 15%. This topic, however, has been largely done to death already.

There are are some very useful sources of carefully curated content that I enjoy following every year and in this post I’m going to direct you to some of those and highlight where I think the critical topics are in lymphomas.

Companies mentioned: Roche, GSK, AbbVie, Pharmacyclics, Gilead, Infinity, Seattle Genetics

Drugs mentioned: Rituxan, Arzerra, Gazyva, ABT-199, ibrutinib, idelalisib, IPI-145, Adcetris 

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