Biotech Strategy Blog

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

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?


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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Oncology R&D is tough and there are many more failures than successes, despite the FDA approving more than they’ve rejected over the last two years. That’s quite unusual in my experience.

Dr Mario SznolAs Dr Mario Sznol (Yale) told us at SITC recently, sometimes these things are sometimes more whimsical. He was referring to different types of modalities that can be used in conjunction with cancer immunotherapies, but the sentiment is also highly relevant to the FLT3 AML space.

The critical questions we need to think here about are:

  1. What’s different about the various approaches?
  2. What can we learn from the FLT3 experiences to date that give us clues about the changing landscape in AML?

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It’s that time of the month where the BSB readers get their chance to put us on the hot spot!

SITC 2015 Land GrabHere, we take a look at reader questions that have been submitted and argue the toss – is there evidence preclinically or clinically that is useful or instructive?

We can’t promise to answer every question, sometimes there simply isn’t any data to help either way.

This week, the topic is CAR T cell therapies, a subject that seems to be very high on many people’s minds and many of you had similar questions, so here goes…  

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Dr Mario Sznol

Dr Mario Sznol at SITC 2015 Patient Forum

Novel Immunotherapies and Combinations” was the title of the talk by Dr Mario Sznol (Yale) at the recent Immunotherapy Patient Forum co-hosted by Global Resource for Advancing Cancer Organization (GRACE) and the Melanoma Research Alliance at the 2015 SITC annual meeting.

At the forum, Dr Sznol also led a breakout session, where he reviewed what is melanoma, the treatment of primary melanoma and management of advanced disease, as well as answering questions from the patients and patient advocates.

Often at medical meetings you hear the results of a clinical trial that is but one piece of the jigsaw, so it was interesting to hear a more comprehensive overview of the disease.

Dr Sznol kindly spoke with BSB about his vision for the future of cancer immunotherapies. This post includes excerpts from the interview along with additional commentary.

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ASH 2014 San FranciscoThe 2015 annual meeting of the American Society of Hematology (ASH) (Twitter #ASH15) in Orlando has a bumper crop of interesting data.

ASH is one of the my favourite meetings on our conference calendar. I’ve been attending for many years, starting with when I was a commercial account manager for Hematology, Immunology, Transplantation and Oncology in the UK, then at Novartis in the US, when I was part of the team that brought Gleevec to market.

Hematologists make for an interesting group of people to talk to!  They are very focused on the science behind a disease and how translational research can move the needle forward and generate better outcomes for their patients.

As part of our continuing preview of #ASH15, I’ve taken a quick look at the late-breaking abstracts that were released today. We will have more in-depth coverage after we’ve heard the data presented in the 7.30-9.30 am session on Tuesday December 8.

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If you’re not already a subscriber, but what to know “What’s hot at ASH15?” then you should purchase access.  Additional ASH previews are already planned.  By the time you’ve read them, you should “hit the ground running” in Orlando.

As Warren Buffett famously said, “Price is what you pay. Value is what you get.” I couldnt agree more. We have subscribers who just purchase our ASH coverage every year, so do check it out if you haven’t done so already.

Readers may recall at the 2014 annual meeting of the Society for Immunotherapy of Cancer (SITC) we wrote about the work of Dr Marcel van den Brink (MSKCC) on how the composition of bacteria in the gut can have an impact on graft-versus-host disease (GvHD), and survival post bone marrow transplant. See post: Can you reduce Graft versus Host Disease GvHD by regulating gut bacteria?

At SITC 2015, we heard from Dr Tom Gajewski (University of Chicago) who presented work from his laboratory, recently published in Science, that shows the gut microbiota can also impact the efficacy of checkpoint inhibitors.

Tom Gajewski SITC 2015

Dr Gajweski is one of the foremost cancer immunotherapy researchers in the United States. He previously spoke with BSB about his work on the STING pathway, and how the tumor microenvironment impacts checkpoint inhibitor efficacy. See post: Tom Gajewski takes the STING out of Cancer.

In his extremely busy schedule at SITC, Dr Gajewski found a few minutes to talk about his latest research and future plans.

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It’s Friday 13th, a day often feared by the superstitious, but for AstraZeneca it certainly portended good news with the FDA approval of AZD9291 or osimertinib (now Tagrisso) in EGFR T790M mutation-positive lung cancer – three months ahead of the PDUFA date. Jonathan Rockoff, a reporter at the WSJ, was the first to announce it in my Twitter stream:

Tagrisso 80mg

Tagrisso 80 mg. Picture credit: AstraZeneca

The FDA announcement for Tagrisso (generic name is osimertinib) can also be found here and the actual label here.

Note that it is now available under accelerated approval, based on tumor response rate and duration of response. This means that phase III confirmatory trials, including survival data will be needed for full approval.

As part of our ongoing series on the T790M niche, this is also a timely opportunity to catch up with the latest data that was presented earlier this month at the AACR-NCI-EORTC Cancer Therapeutics and Molecular Targets meeting in Boston.

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Some people may think that if you just give a whole boat load of engineered T cells, and in particular, those modified with a Chimeric Antigen Receptor (CAR), that responders are “cured.”

While some recipients of engineered T cells can have long-term, durable remissions, others may initially respond, only to subsequently relapse.

Resistance to CAR T cell therapy can and does occur.

In this post, we talked with a leading expert about the latest research on how resistance to cell therapy develops, and the potential strategies to overcome it.

CAR T cell therapy is exciting, but remains an emerging field with multiple ways in which the competitive landscape may be shaped moving forwards.

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