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.”
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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One 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.
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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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.
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.
As 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:
What’s different about the various approaches?
What can we learn from the FLT3 experiences to date that give us clues about the changing landscape in AML?
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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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The 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.
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, new lung cancer drug from $AZN, is approved by @US_FDA, w/ companion diagnostic from $ROG.VX to identify EGFR resistance mutation
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.