Biotech Strategy Blog

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

Posts tagged ‘obinutuzumab’

Over the last five years the face of the chronic lymphocytic leukemia (CLL) landscape has changed quite dramatically with the advent of new approvals in several categories. These include anti-CD20 antibodies, BTK inhibitors, PI3K inhibitors and apoptotic Bcl–2 inhibitors.

In yesterday’s wide ranging interview we explored in-depth how these therapies are impacting the broader landscape, as well as emerging trends in how these regimens might be used.

In Part 2 of the ongoing series, we spoke with another CLL expert and explored promising new and earlier agents in development for a different perspective on how outcomes might be improved further.

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Targeted therapy and Chemo-Immunotherapy in CLL

At last December’s 2016 annual meeting of the American Society of Hematology, one of the areas that attracted attention was the latest clinical data on the treatment of chronic lymphocytic leukemia (CLL).

ASH 2016 in San Diego

In recent years, we’ve seen tremendous advances in the field with several new agents approved such as obintuzumab, ibrutinib, idelalisib, and venetoclax. There are also new treatment options available for CLL patients with high risk disease such as 17p deletions (Del17p).

Other new targeted therapies such as acalabrutinib are now in clinical development, plus we have CAR T cell therapies and combination strategies also being evaluated in the clinic.

So what was the hot news from #ASH16 in CLL?

  • Does chemotherapy still have a role or is it a targeted therapy world?
  • Are we further forward towards a cure?
  • Have we worked out how to identify those at risk of relapse?
  • Will CAR T cell therapy be a game changer in CLL?
  • Is financial toxicity going to be an issue with combination strategies?

BSB interviewed two experts in CLL while in San Diego who kindly shared their thoughts on which CLL data impressed them at the ASH annual meeting and discussed some of the big strategic issues facing the field right now. These interviews are being posted in a two-part series.

Part 1 today answers some of the questions highlighted above and explores the changing face of the broader CLL landscape.

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John P. Leonard, MD is the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell in New York. He’s a Lymphoma specialist.

Dr John Leonard at ASH16

Like many hematologists, he’s embraced Twitter as way to share his expertise with others in the hematology community. You can follow him at @JohnPLeonardMD.

Over the last couple of years prior to the ASH annual meeting, Dr Leonard has highlighted 10 lymphoma abstracts that caught his attention. You can tell he gets excellent social media pickup by the fact he’s even generated a hashtag to make them easy to find: #Leonardlist and other hematologists generate conversations around his eagerly awaited picks:

In case you missed them on Twitter, and in the spirit of David Letterman, Dr Leonard took me through this year’s #LeonardList and thoughtfully explained in detail why each selection made the cut… for oncology watchers, the why is often more important than the what.

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San Diego – after “Flying Friday” where I flew from Munich to San Diego, Biotech Strategy Blog coverage of the 2016 annual meeting of the American Society of Hematology (ASH) is now done for another year.

Downtown San Diego during ASH 2016 With over 27,000 attendees – it’s the largest ASH annual meeting I’ve seen in 20 years of coming here!  ASH is definitely the pre-eminent global meeting for hematology and blood cancers.

As you might expect, the thought leaders at this event are super-busy, but we’ve already managed to catch up with a few, and we’ll be rolling out interviews in the “post-game show.”

Subscribers have been asking what’s really hot at ASH this weekend, so reflecting my interests and the sessions I went to, here are my seven highlights/learnings of ASH 2016 (so far). There’s a lot more data to come!

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The abstracts (apart from the late-breakers) for the 2016 annual meeting of the American Society of Hematology (Twitter #ASH16) went live at 9am ET today. Link to 2016 ASH Abstracts.

ASH16 takes place in San Diego from December 3-6.

View of San Diego from ASH 2011In this initial post, I’m sharing my first impressions of what may be some hotly contested trials at ASH16 in San Diego, as well as a few intriguing abstracts with combination data that caught my attention.

With over 3,000 oral and poster presentations, all typically of a high quality, this by post by definition, is a highly subjective one.

After we’ve had more time to process the data, further ASH16 Previews will roll out over the next few weeks highlighting more key abstracts to watch out for by tumour type or treatment modality.

In-depth commentary and analysis will follow after we’ve heard or seen the data presented at the meeting.

I’ll be flying to ASH from the EORTC-NCI-AACR Molecular Targets meeting. Do say “hello” if you have plans to be in Munich or San Diego.

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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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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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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.

To learn more about these insights and how ABT–199/GDC–0199 could impact the future CLL landscape, log-in to access the article.

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:

Beyond the noise of the exciting the data in CAR-T cells, CLL, NHL and multiple myeloma, one of my favourite pastimes at cancer conferences is to look out for up-and-coming gems in the poster halls.

By this I mean interesting novel targets or very active agents in the pipeline.

One of the most eagerly awaited targets on my list was the Killer Immunoglobulin-like Receptor (KIR). It may be a key part of overcoming lymphoma resistance and inducing cell death. If you don’t kill the cancer cells, you likely won’t see remissions occurring.

Companies mentioned: Innate Pharma, BMS, Roche
Products mentioned: IPH2101, IPH2102 (lirilumab), ipilimumab, rituximab, obinutuzumab, anti-PD-1, anti-PD-L1

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