Biotech Strategy Blog

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

Today the immunotherapy and related data flooding out of the annual meeting of the San Antonio Breast Cancer Symposium (SABCS) is pretty exciting!

Data was presented on a number of drugs including pembrolizumab, avelumab and atezolizumab, which put together with some recent publications, highlights some potentially exciting opportunities in this fast moving space.

Here, we explore the potential for checkpoint therapy combinations in TNBC, HER2 and even the ER+ subsets.  There’s a lot of new findings to take in and contemplate here.

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ASH 2015 Manic Monday

The #ASH15 wall of people marching to the poster hall just after 5pm

Orlando – it’s Monday at the annual meeting of the American Society of Hematology (ASH) annual meeting, a day I call “Manic Monday” because there are so many simultaneous sessions, you end up running around frazzled, in/out of sessions, in the hope of catching all the presentations of interest.

It’s particularly challenging if you are in a full session — you won’t be able to get back in if you leave — which results in having to make difficult choices on what to see and where to run to.  Some of the myeloma thought leaders were urging colleagues to tweet sessions they couldn’t be in, so “Manic Monday” may be a good time to contribute to the collective ASH Twittersphere.

We’re starting today’s rolling post with my notes from the lymphoma New Drugs session yesterday, then we’ll be updating the blog as the day goes by, as the opportunity permits.

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ASH 2015 Hematology Orlando

ASH 2015 — taken before 7am!

Orlando – a presentation in the plenary session at #ASH15, the 2015 annual meeting of the American Society of Hematology, is the pinnacle of any doctor or researcher working in the hematology field.

Yesterday, we had the privilege to interview Dr Richard Stone (Dana-Farber Cancer Institute) ahead of his plenary presentation at ASH:

Abstract 6: The Multi-Kinase Inhibitor Midostaurin (M) Prolongs Survival Compared with Placebo (P) in Combination with Daunorubicin (D)/Cytarabine (C) Induction (ind), High-Dose C Consolidation (consol), and As Maintenance (maint) Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) Patients (pts) Age 18-60 with FLT3 Mutations (muts): An International Prospective Randomized (rand) P-Controlled Double-Blind Trial (CALGB 10603/RATIFY [Alliance])

Anyone who has been to an ASH education session on AML knows how hard a nut it is to crack, so it’s wonderful to see some positive data, in what is commonly considered to be a “graveyard” disease.

The trial has taken a long time to come to fruition, so all credit to Dr Stone and colleagues. We’ll be writing up more about the data in our post meeting coverage.  For additional background, you can also check out our FLT3 preview in AML, which details some of the history and context for this study. The data from the phase 3 study is likely to form the backbone of a registration filing for Novartis with this compound in the near future based on successfully meeting the trial endpoints.

We also kick off today’s highlights with quick reflections on some of the hot topics that emerged yesterday including Bluebird Bio’s lentiglobin, Bellicum’s pipeline and .

During the day, as the opportunity presents, we’ll also be providing commentary on sessions we attend.

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ASH 2015 OrlandoOrlando – the 2015 annual meeting of the American Society of Hematology (Twitter #ASH15) kicks off in earnest today at the Orange County Convention Center.

There’s a comprehensive press program at #ASH15, which will no doubt drive a lot of the media coverage, but in addition to discussing some of the highlights, we’ll be going off the beaten path, and gathering noteworthy data for our post-meeting coverage.

There’s always a lot of great posters at the meeting, as well as useful educational and scientific sessions.

If you are interested in checkpoints in hematology, do check out the Scientific Session chaired by Dr Krishna Komanduri (@drkomanduri) “Checkpoint, Please?” It takes place from 9.30 am to 11 am today. It’s repeated again from 4 to 5pm on Sunday.

As the conference program notes, “this session will provide a broad overview of checkpoint inhibition and its therapeutic potential in the setting of solid tumors, alloreactivity and treatment of hematologic neoplasms.”

This is a rolling blog post, throughout the day we’ll be adding commentary as the opportunity presents.

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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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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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This year has been an unprecedented Grand Cru year for the field of multiple myeloma, with no less than four drugs approved by the FDA to date… the fourth one just this morning while writing this preview!

  • Panobinostat (Farydak) in relapsed/refractory disease in combination with bortexomib plus dexamethsone after at least 2 prior therapies.
  • Daratumumab (Darzalex) received accelerated approval based on phase 2 data and is human CD38-directed monoclonal antibody that is indicated for the treatment of patients who have received at least three prior lines of therapy.
  • Ixazomib (Ninlaro) is the first oral proteasome inhibitor and is approved in combination with lenalidomide plus dexamethasone, in people who have received at least one prior treatment.
  • Elotuzumab (Empliciti) is a monoclonal antibody against CS–1/SLAMF7 approved today in combination with lenalidomide plus dexamethasone after 1–3 lines of prior therapy.

There are also many promising new agents in development and quite a few that may well not make it to market as a result of newer, better tolerated agents coming through.

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Biomarkers are a hotly debated topic at the moment within the cancer immunotherapy field.

At the recent Society for Immunotherapy of Cancer annual meeting (SITC 2015), there was even a debate with industry representatives arguing the “pros” and “cons.” Daniel Chen, MD PhD from Genentech (pictured right) argued “pro” and Steven Averbuch MD (pictured left) from BMS argued “con.”

SITC 2015 Biomarker Debate

The challenging question for anyone at the moment is if your Parent, Spouse or Best Friend were PD-L1 negative, would you still want them to receive a PD-1/PD-L1 checkpoint inhibitor (presuming it was indicated for the disease) and have a chance of a response, even if their PD-L1 negativity would suggest only a slim chance of responding?

AT SITC 2015 we spoke with an industry expert who offered insights into a leading company’s biomarker strategy and what the future may look like in 5-7 years time.

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ASH 2014 cHL PembroOne of the hotly debated topics at the 2014 American Society of Hematology (ASH) annual meeting was the arrival of checkpoint data in classical Hodgkin’s lymphoma (cHL), with initial data presented on 20-30 patients with relapsed or refractory cHL who received either nivolumab (BMS) or pembrolizumab (Merck) in open label, single agent trials.

Updated phase I data is expected to be presented at the 2015 ASH annual meeting in Orlando (Dec 5-8) (Twitter #ASH15)

At the recent ESMO symposium on Immuno-Oncology in Lausanne (Twitter #Immuno15) – great hashtag, there was an excellent overview of checkpoint blockade in lymphomas. What did this tell us about progress in this disease and where are things going?

ESMO-Symposium-on-Immuno-Oncology-2015-banner

The ESMO IO meeting set the scene for what we can expect at ASH this year?

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Dr Chris Heery NCIDr Chris Heery (@ChrisHeery) is a medical oncologist at the National Cancer Institute (NCI) who works in the Laboratory of Tumor Immunology and Biology (LTIB) with Jeffrey Schlom, James Gulley and other translational scientists.

The aim of the LTIB is to develop novel immunotherapies for cancer. One of the ways this is accomplished is through a Cooperative Research and Development Agreement (CRADA), in essence a joint venture with the private sector.

At the recent Society for Immunotherapy of Cancer (SITC) annual meeting, Dr Heery presented a poster on the results of a phase 1 clinical trial to evaluate the safety and tolerability of a therapeutic vaccine, MVA-BN Brachyury, targeting brachyury. See Bavarian Nordic Press Release Nov 3, 2015.

We previously heard at ASCO 2015 about the rational for targeting brachyury from Dr James Gulley (see post: Future of Prostate Cancer Immunotherapy).

It was a pleasure to talk with Dr Heery about his poster and what the potential of therapeutic cancer vaccines may be in the cancer immunotherapy arsenal.

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