Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts from the ‘Lymphoma’ category

Yesterday evening, Gilead announced that the Data Monitoring Committee (DMC) had recommended early stoppage of the 116 trial, which looks at idelalisib in relapsed/refractory disease in patients who are not eligible for chemotherapy.  These patients usually have comorbidities or are elderly and frail, and often receive chlorambucil or rituximab alone.  The study compared the combination of idelalisib plus rituximab versus rituximab alone.

Fortunately, the early stoppage was for a good reason – the interim analysis demonstrated a statistically significant improvement in PFS in favour of the combination over rituximab alone.  Adverse events were consistent with previous experience of the drug.

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Yesterday, Gilead announced on their 2Q Earnings Call that they plan to file their PI3K delta inhibitor, idelalisib (formerly CAL-101), with the FDA later this year in indolent non-Hodgkin’s Lymphoma (iNHL). Discussions with both FDA and EMA have already been initiated based on the phase II results in CLL and iNHL.

Many of you will recall the CLL data presented at ASCO by Dr O’Brien (MD Anderson) and Jennifer Brown (Dana Farber), followed by the iNHL data update presented in Lugano by Dr Salles (Lyon Sud).

At the recent ASCO 2013 meeting in Chicago, I had the great pleasure to interview Susan M. O’Brien, MD who is the Ashbel Smith Professor in the Department of Leukemia at the University of Texas, MD Anderson Cancer Center in Houston, and someone who is making a difference to the lives of CLL patients.

ASCO 2013 Dr Susan O'BrienI first met Dr O’Brien over ten years ago when I was at Novartis Oncology in new products working on bringing to market what was then known as STI571, and subsequently became Gleevec.

After the hullabaloo on Friday regarding AbbVie’s suspension of the ABT-199 trials following not one, but two, unexpected deaths from tumor lysis syndrome (TLS), a few people asked what is this condition and what causes it?

In simple terms, lysis is a medical word used to describe the break up or breakdown of cells – whether through decomposition, destruction, or dissolving. Thus, we have hemolysis, which is the destruction of red blood cells with the release of hemoglobin.


New York City NYC view Photo Credit: Sally ChurchThis week I’m attending an interesting 2-day conference on PI3K at the New York Academy of Sciences (NYAS).

It brings together a broad faculty of researchers in the field looking at novel aspects of the PI3K-Akt-mTOR pathway in depth.

One aspect that has become clear with these compounds is that there’s probably more that we don’t know than we do – it’s a highly complex network of nodes and cause-effect that needs to be unravelled.

I’ve been busy with other things offline since the last blog update from the American Society of Hematology (ASH) meeting in San Diego, but will be catching up on my notes from the conference over the next few days.

In addition, my colleague Pieter Droppert has already posted his topline impressions of the meeting on the companion Biotech Strategy Blog, which readers may be interested in:

  1. Ponatinib in CML
  2. Update on new advances AML and FLT3
  3. Interesting posters – BTK and PI3K

Meanwhile, I thought it would be a good idea to look at the pipeline developments in non-Hodgkin’s lymphomas (NHL) that I particulalry liked at ASH:


This year’s American Society of Hematology (ASH) meeting heralded a wealth of new information on pipeline compounds in early development. Although a lot of people were excited about myelofibrosis and the battle between Incyte’s ruxolitinib and YM Bioscience’s CYT387 (more on these in a separate update), the area that intrigued me most was the Bruton’s Tyrosine Kinase (BTK) inhibitors in B-cell lymphomas.

Background on the science behind the BTK pathway:

I’ve been following these novel agents for a while and was fascinated by two abstracts from the ASCO and ASH meetings last year. It became clear that BTK is a valid target in B-cell lymphomas after Advani et al., (2010) demonstrated at ASCO the effect of BTK inhibitor PCI-32765 monotherapy on responses in patients with relapsed aggressive NHL.1


It doesn’t seem a full year since the last American Society of Hematology (ASH) meeting took place, time has certainly flown by!

For those interested, I posted a review what I think will be hot topics at this meeting

In the meantime, to enable easy reading of the tweets and discussions here in San Diego for those both attending and following remotely, I’m aggregating the tweets around the official hashtag, #ASH11.

You can follow the conversations over the weekend through Tuesday in the widget below:


Palm trees in downtown San Diego

Greetings from the annual American Society of Hematology (ASH) meeting in San Diego!

The palm trees and warm sunshine here were a most pleasant welcome after the bitter chill in Texas.

Having just arrived here from the San Antonio Breast Cancer Symposium, I thought it would be a nice idea to do a quick preview of some of the new and interesting data that I’m interested in at this conference and share some of the hot topics that I’ll will be following over the weekend:

  • Ponatinib in refractory CML
  • In myelofibrosis, rixuluximib and CYT-387

Last week brought the first anniversary of this blog since moving to WordPress as a platform, but as luck would have it, I was snowed under with more work than usual.

Several people have asked about the stats here recently, so it seems a good time as any to do an annual review. Although this blog has been up and running since 2006, it only started on WP on October 24th 2010.

In the last twelve months, PSB has seen the following activity:

  • 614K reads, with around 50-60K reads per month
  • 337K visitors, approx. 30K visitors per month
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