Biotech Strategy Blog

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

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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A burning question in the field of cancer immunotherapy is how long do you have to give a checkpoint inhibitor for?

At the recent Society for Immunotherapy of Cancer (SITC) annual meeting, new data presented by one of the leaders in the field, offered insight (from an unexpected direction) into what the answer to this question may be.

It has huge implications for cancer immunotherapy treatment and the many companies involved in this space.

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That’s the $64K question we all want to know, and what’s more is gene editing necessary when it comes to creating an “off-the-shelf” T cell therapy, which instead of modifying a patient’s own T cells (autologous), uses cells from a healthy donor (allogeneic)?

We were really curious too, and sought out one of the world’s leading experts for their opinion on this very issue.

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SITC Day 4 Highlights

It’s been an interesting annual meeting at the Society for Immunotherapy of Cancer (SITC) so far and not without controversy either, as the reaction to Incyte’s IDO1 data demonstrated on Friday when combined with Merck’s pembrolizumab (sse post).

Today, we heard the results from another early trial with a novel immune target. This time it was the turn of Macrogenics, a local biotech based up the road in Rockville, Maryland.

They are developing a number of monoclonal antibodies to a variety of targets, including B7-H3. After the controversial late breaker session on Friday, how did their drug fare in the hotseat here in National Harbor this morning?

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SITC Day 3 Highlights

There were a couple of late breakers presented in the oral session yesterday that are worth discussing for several reasons, not least the controversy surrounding the stock action afterwards.

Dr Tara Gangadhar (U Penn) presented epacadostat, Incyte’s IDO1 inhibitor, in combination with pembrolizumab, Merck’s anti-PD1 inhibitor in a phase 1/2 trial with selected solid tumours.

Will combining these agents lead to better responses and outcomes than with pembrolizumab alone?

Dr Naiyer Rizvi (Moffitt) presented the combination data of AstraZeneca’s anti-PDL1 (durvalumab) plus anti-CTLA4 (tremelimumab) in patients with non-small cell lung cancer (NSCLC).

Neither of these agents have yet been approved in any indication, so the only relative comparators we have here are nivolumab and pembrolizumab as single agents in NSCLC and ipilimumab plus nivolumab in metastatic melanoma. There are no data approved for the BMS combo in lung cancer.

This review looks at both trials, in terms of the controversial data presented, and also in a broader context of the ever-changing landscape.

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SITC 2015 National Harbor Gaylord MDNational Harbor, MD.  Today was a busy day with the ASH abstracts coming out this morning, and some ground-breaking data that demanded an immediate #ASH15 preview post.

At the same time we’re here at SITC, and keeping an eye on the AACR-NCI-EORTC Molecular Targets meeting – it’s like three buses come at once!

So what happened at SITC today? In this post we’ve put a quick summary of some of the presentations we heard on Day 2 that stood out.  Sometimes what’s most important is what people don’t say.

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