Biotech Strategy Blog

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

Posts tagged ‘DLBCL’

Hans Bishop, Juno

After a rocky 2016 for Juno with JCAR015 and the trial that imploded unexpectedly and badly, the CEO Hans Bishop quietly announced that announced that ROCKET has been abandoned:

“2016 was a year of progress and learning for Juno and the cancer immunotherapy field. We continue to experience encouraging signs of clinical benefit in our trial addressing NHL, but we also recognize the unfortunate and unexpected toxicity we saw in our trial addressing ALL with JCAR015. We have decided not to move forward with the ROCKET trial or JCAR015 at this time.”

A strange year of hubris attracting nemesis might be another way of describing the events for some observers.

We covered the Juno roller coaster and events in July and December 2016 for those who want to catch up on the full history of this unfortunate and ongoing debacle:

Where does the latest Juno news leave things and what can we expect going forward?

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One of the interesting and exciting parts of major medical meetings such as the ASH annual meeting, held last month in San Diego, is hearing about new compounds in development.

When it comes to the treatment of aggressive lymphomas, there remains a high unmet medical need to improve the response rate to first line treatment, as well as offer better outcomes post relapse.

At #ASH16, we heard more about a novel ADC called polatuzumab vedotin (Genentech/Roche).

Preliminary safety and clinical data for polatuzumab plus obinituzumab in relapsed or refractory Non-Hodgkin Lymphoma (NHL) was presented in an oral session by Dr Tycel Phillips (University of Michigan).

Three posters were also presented showing early data in combination trials in R/R follicular lymphoma (FL) and diffuse large B cell lymphoma (DLBCL), as well as in first line DLBCL.

To find out more about the potential of this novel ADC, BSB spoke with Dr Michael Wenger, Senior Group Medical Director at Roche Genentech.

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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 – Monday at the 2016 Annual Meeting of the American Society of Hematology (#ASH16) is typically a day of multiple oral sessions in parallel.

This year it was a major challenge doing a mad dash between sessions as the meeting is now so big that in San Diego it’s being held, not only at the vast convention center, but is also using the meeting rooms of three nearby three hotels – it’s literally a mile walk to go from one end of the convention to the other, so you have to factor that time into your crazed schedule with multiple clashes.

On the positive side, there’s even courtesy pedicabs – cycle rickshaws (great idea & fun) – I caught one at 7am the other day to save my toes from at least one #blisterwalk…

Pedicab at ASH16 in San Diego

Following on from our ASH Highlights 2016 Part 1, this post answers critical BSB Reader questions that have come in thick and fast and require more than 140 characters on Twitter to answer.

Predictably, the majority of the first tranche of questions have been CAR T cell therapy related, so if you have a keen interest in this area, this is the post for you.  We tackle 5 critical questions and offer some insights.

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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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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

This week certainly turned out to be a defining tale of two drugs with a chequered history…

Lion DancersFirst 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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SGEN Booth ASH15

Seattle Genetics ASH 2015 Exhibit – photo with permission

San Francisco – Seattle Genetics are presenting later today at the JP Morgan Healthcare conference (2.30pm PST) and we’ll be covering this as part of our daily rolling blog.

As blog subscribers already know, one of the presentations that caught our attention at ASH 2015 was the updated phase 1 data for Seattle Genetics latest ADC, denintuzumab mafodotin (SGN-CD19A) in B-cell malignancies, including diffuse large B-Cell lymphoma (DLBCL).

Unlike with brentuximab vedotin, where one of the main side effects seen is peripheral neuropathy, with 19A, as it’s commonly known, there is ocular toxicity. Will this toxicity bring the house of cards down for Seattle Genetics?

I spoke to President and CEO Clay Siegall, PhD about this, the company’s corporate strategy moving forwards in 2016 and how checkpoint inhibitors may impact classical Hodgkin’s Lymphoma (cHL).

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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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One of the overlooked highlights from ASCO this year was new data in diffuse large B cell lymphoma (DLBCL), which is an aggressive form of Non-Hodgkins Lymphoma (NHL). DLBCL is the most common form of NHL accounting for nearly one third of newly diagnosed NHL cases each year in the USA. Most of these people are adults rather than children.

The first sign of DLBCL is often a painless rapid swelling in the neck, armpit, or groin, which is caused by enlarged lymph nodes. Other symptoms can include night sweats, unexplained fevers, and weight loss.

Aggressive lymphomas such as DLBCL behave very differently from indolent NHL (iNHL) since they are faster growing and generally have a much poorer prognosis. As a result, they are treated much more aggressively with rituximab plus chemotherapy regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). Sometimes etoposide (E) is added in younger patients with a high disease burden, in which case the regimen is known as R-EPOCH.

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