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

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AACR16 RegistrationNew Orleans – it’s Day 3, Monday, at the 2016 annual meeting of the American Association for Cancer Research (AACR). Attending AACR for the first time can be a daunting prospect, with a full program of activities from dawn to dusk.

For those of who don’t regularly go to large medical meetings, it’s all too easy to forget the sheer scale of the event and how mach walking is involved up and down long corridors – it’s easy to clock up 15,000+ steps on your Fitbit!

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New Orleans AACR 2016New Orleans – here at the annual meeting of the American Association for Cancer Research (AACR), the emphasis has shifted from yesterday’s education program to the start of the scientific programme.

If you didn’t make it to the Cell Press/Nanostring, “What’s Next: Bit Topics in Cancer Immunology” event yesterday evening at the Bourbon Orleans hotel in the heart of the French Quarter, you missed a great unofficial AACR16 event that featured a panel of leading experts:

  • Aviv Regev, PhD (Broad Institute of MIT and Harvard)
  • Tom Gajewski, MD, PhD (University of Chicago)
  • Dan Chen, MD, PhD (Genentech)
  • Pam Sharma, MD, PhD (University of Texas MD Anderson Cancer Center)
  • Michel Sadelain, MD, PhD (Memorial Sloan Kettering Cancer Center)
  • Jerome Galon, PhD (INSERM)
  • Ira Mellman, PhD (Genentech)
  • Catherine Wu, MD (Dana Farber Cancer Institute)

Throughout the day, schedule permitting, we’ll be posting top-line commentary from the sessions we’ve been in.

You can also catch up with the commentary from the Day 1 Live Blog, which has several updates from yesterday (Link).

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New Orleans StreetCarNew Orleans – the annual meeting of the American Association for Cancer Research (AACR) starts in earnest today with a full program of educational sessions presented by leading experts in different fields.

There’s a lot going on at AACR, with many sessions in parallel, so always remember the “law of two feet” – if the session you are in isn’t interesting, what you expected or isn’t meeting your needs – get up and go to another one!

Starting today and through Tuesday will be posting a daily blog with commentary around the sessions we attend and the people we speak to. It won’t be real-time, but to the extent possible we’ll be providing updates during the day.

It kills us to do semi-live posts from conferences, but they’re popular with subscribers, many of whom enjoy reading top-line commentary during the meeting, then our in-depth pieces later.

If you’d like to join the club of readers who enjoy access to our content, much of which by definition is exclusive – we don’t think anybody else does what we do or talks to as many thought leaders….

The good news is that a quarterly subscription will also cover you for ASCO 2016 in Chicago.  If you’d like to support our conference coverage, you can purchase access below. Subscribers can login to read more.

European Lung Cancer Conference 2016

European Lung Cancer Conference 2016

Geneva – At the 2016 European Lung Cancer Conference (ELCC) today, one of the highlights to watch out for is the presentation of first-line data for AstraZeneca’s ($AZN) third generation EGFR inhibitor osimertinib (Tagrisso), formerly known as AZD9291.

At 3.30pm in Geneva (9.30am on the East Coast of the United States), Dr Suresh Ramalingam (Winship Cancer Institute, Emory) will present updated data from two expansion cohorts of the AURA phase 1 trial (NCT01802632) with updated results on the use of osimertinib in the first-line setting:

LBA1_PR: Osimertinib as first-line treatment for EGFR mutation-positive advanced NSCLC: updated efficacy and safety results from two Phase I expansion cohorts. S. Ramalingam, J.C.-H. Yang, C.K. Lee, T. Kurata, D.-W. Kim, T. John, N. Nogami, Y. Ohe, P.A. Jänne

Do follow tweets from the conference (#ELCC16).

As Dr Ramalingam noted in a press release issued by the European Society for Medical Oncology (ESMO):

“The overall response rate was among the best reported for first-line therapy of EGFR mutated NSCLC. The PFS results are exciting, well exceeding the historical control rates of 10 to 13 months with first or second generation drugs. Many of the patients have not had disease progression on the study and are still benefitting from treatment.”

Readers will recall osimertinib was approved by the FDA last November (link to press release) for the treatment of advanced non-small cell lung cancer (NSCLC) in patients who test positive for an epidermal growth factor receptor (EGFR) T790M mutation following prior treatment with an EGFR tyrosine kinase inhibitor (TKI).

Nearly two-thirds of patients who receive an EGFR-TKI develop a T790M mutation, and until the approval of osimertinib, there were no approved treatment options.

I vividly remember being in the audience at the European Cancer Congress in Amsterdam back in September 2013 and listening to Professor Malcolm Ranson (Christie, Manchester) present the first clinical data from the phase 1 study, which at that time was only a single center. See post: ECCO 2013: AZD9291 shows early promise in NSCLC.

Dr Ross Camidge (Denver), who was the discussant in Amsterdam, concluded his discussion with a picture of the first step on the moon. Cancer metaphors around the moon and moonshots have since become overused, but I think this one was justified at the time:

“By addressing acquired resistance at the molecular level potentially creating one small step in the EGFR treatment paradigm, third-generation inhibitors like 9291 are likely to represent one giant leap forward in the treatment of EGFR mutant disease.”

~ Dr Ross Camidge at ECC 2013.

Whatever the role we play in cancer drug development, and most of us are but bit players, we live for moments like that. Dr Camidge’s visual metaphor remains etched on my memory as a landmark moment when all in the audience saw the first glimpse of a drug that could make a difference.

We’ve been following the development of osimertinib over the past 3 years and the race to market with Clovis Oncology’s rociletinib (formerly known as CO-1686). See e.g. AstraZeneca ramps up AZD9291 lung cancer clinical development, AstraZeneca leaps over Clovis with AZD9291 data at World Lung Conference.

Looking back, when you compare the development of osimertinib to rociletinib, it is a “Tale of Two Cities,” to paraphrase the title of a novel by Charles Dickens.

In a recent article (open access) published in Annals of Oncology, Dr Antoine Yver, Senior VP at AstraZeneca described how fast the development of osimertinib was:

“The development programme for osimertinib is the most rapid to date, taking just 24 months from filing the FDA Investigational New Drug Application to submitting the FDA New Drug Application and just 2 years 8 months and 1 week from the first patient dosed to the first approval.”

To put this in context, the speed of the osimertinib development rivals – and perhaps even just beats – the accelerated development of imatinib (Gleevec) by Novartis from Feb 1998, when the first patient was dosed, to approval in May 2001, a tremendous achievement.

Key to AstraZeneca’s success was the company’s previous experience in bringing gefitinib (IRESSA) to market in EGFR lung cancer.

The development of osimertinib by AstraZeneca offers a new case study to other companies in how to bring a drug to market.

Sadly, the drug development by Clovis Oncology offers the exact opposite, as evidenced by the recent meeting of the FDA Oncology Drugs Advisory Committee, which recommended (12 to 1) against accelerated approval of rociletinib for the same indication as osimertinib. See FDA ODAC meeting briefing documents (link).

So what do we learn from the first-line osimertinib data presented at European Lung?

Dr Pasi Jänne at ASCO 2014

Dr Pasi Jänne, Dana-Farber Cancer Institute pictured at ASCO 2014

I spoke with the senior author of the LBA_1 PR abstract at European Lung, Dr Pasi Jänne, who is Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute (DFCI) and Professor of Medicine, Harvard Medical School about the significance of the data presented at European Lung.

During the interview, excerpts of which I’ve posted for subscribers, we touched on acquired resistance to osimertinib and whether rociletinib has any future in the treatment of EGFR positive NSCLC.

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Lemons Villa BorgheseThe discovery of a novel target in castration-resistant prostate cancer (CRPC) and the potential of drugs targeting this to delay or overcome adaptive resistance is the subject of today’s post.

Followers of the prostate cancer field know that one of the challenges with drugs such as enzalutamide and abiraterone is that patients stop responding to them over time and they develop acquired resistance.

So imagine that you could give a drug that is not only an effective anti-cancer agent in patients with acquired resistance, but might then allow those treatments to be effective a second time around.  A recently identified druggable target means this is now a possibility.

Of course, it’s early days yet, and the preclinical work has yet to translate into humans, but it’s not hard to see the commercial implications in the prostate cancer landscape for companies such as $MDVN, $JNJ, $TKAI, Bayer and anybody else who wants to be a player.

Interested? Subscribers can login to read more or you can purchase access below. This post is Day 3 in our Road to AACR 2016 series.

King Kamehameha Statue Honolulu HI

King Kamehameha Statue, Honolulu HI

Honolulu: we’re continuing our coverage of the 2016 BMT Tandem meeting with a thought leader interview about a novel cancer immunotherapy approach that we’re excited about.

The cancer cell therapy landscape is still vastly uncharted territory in many respects.

The first CD19 targeted CAR T cell therapies expected to reach the market in 2017 are unlikely to be best-in-class, which leaves the commercial door open for other approaches that may be better, cheaper or more accessible.

If you are in the CAR T cell therapy space, there are plenty of competitive threats on the horizon, and the novel approach discussed in this post is one of them!

We’d heard a little about it, but hadn’t explored the concept in any detail, so were delighted to talk with a leading expert at the BMT Tandem meeting in Honolulu.

Subscribers can login or you can purchase access to read more about a cell therapy that could offer the benefits of a CAR without the need for genetic modification.

Honolulu: Yesterday we learnt the sad news that Dr Holbrook Kohrt (pictured) had died.

Dr Holbrook Kohrt He was a Stanford hematologist/oncologist and rising star in the cancer immunotherapy field. Our thoughts go out to his family and friends.

I had the privilege to interview him last May at the Immunology 2015 meeting in New Orleans. His voice lives on in Episode 6 of the Novel Targets Podcast. One area of Dr Kohrt’s research was in combination immunotherapies, and how we can optimize efficacy, while avoiding significant immune adverse events.

So are checkpoints playing with fire when given in combination?

That was one of the provocative questions to come out of a scientific session entitled, “Fast Cars and No Brakes: Autologous Stem Cell Transplantation as a platform for Novel Immunotherapies” at the BMT Tandem meeting in Hawaii last weekend. The session, chaired by Miguel-Angel Perales (@DrMiguelPerales) from Memorial Sloan Kettering Cancer Center, was both informative and interesting.

All the presentations were excellent, but one by Philippe Armand from the Dana-Farber Cancer Institute in Boston, “Checkpoint Blockade in SCT, Data & Hope, Promise & Peril” stood out for me. Dr Armand discussed checkpoint data pre and post stem cell transplantation and offered a perspective I had not heard before.

One of the provocative questions it raised was could checkpoints be playing with fire in some patients? Dr Armand kindly spoke with BSB after his talk.

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Honolulu: At the BMT Tandem meeting that ended yesterday in Hawaii, one of the hot topics was CAR T Cell Therapy. This should, perhaps, come as no surprise to readers given that bone marrow transplanters are not only the investigators doing the clinical trials, but will be the initial target market for this product.

Dr Micheal JensenOne of the pioneers in the development of adoptive cellular therapy is Michael Jensen (pictured) who is Director, Ben Towne Center for Childhood Cancer Research at Seattle Children’s Research Institute (SCRI) and the Sinegal Endowed Professor of Pediatrics at the University of Washington School of Medicine. Dr Jensen is also a scientific co-founder of Juno Therapeutics, Inc.

He’s been doing research in the field for over 20 years, and told me that not so long ago there would only be a handful of people in the room for a CAR T cell presentation!

In a plenary scientific session at the Tandem meeting, he presented to over 3,000 attendees on “CD19-Specific CAR T Cells as a Post-ALLO HSCT Relapse Salvage Therapy.”

After his presentation, he kindly spoke with BSB. This post describes some of the key take-homes from his talk.

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Dr David Porter, U Penn

Dr David Porter, U Penn

Honolulu: The BMT Tandem meeting kicked off yesterday with an excellent plenary session on “CAR T Cell Therapy: CD19 and Beyond.” The three presenters were:

  • David Porter (University of Pennsylvania) CAR T cells for Leukemia
  • Martin Pule (UCL) Building a CAR
  • Michael Jensen (Seattle Children’s) CD19-Specific CAR T Cells as a Post-Allo HSCT Relapse Salvage Therapy

Dr Porter (pictured) is Director of the Blood and Marrow Transplant Program at the University of Pennsylvania. I spoke with him after his talk. This post gives a quick overview of some of the key points I took away.

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North Shore Surf Shop SignAloha! The BMT Tandem meeting (Twitter #BMTTandem16) is underway in Honolulu, and we’re looking forward to the scientific presentations that start tomorrow, Thursday.

This preview highlights some of the presentations that may be of interest to subscribers at the meeting over the next 5 days when they’re not surfing waves at the North Shore! The meeting ends on Monday Feb 22.

If you can’t make it to Hawaii, then I expect the BMT community will be sharing updates from the meeting via Twitter. Do follow: @DrMiguelPerales, @DrKomanduri, @sgiraltbmtdoc, @DrMvandenBrink, @BldCancerDoc, @MSKBMTTandem & others (this is not intended to be a definitive list, only a starting point).

We won’t be doing a daily blog, but will be generating some commentary and analysis, as the opportunity presents.

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