The race to the be first to market in the United States with a CD19 directed CAR-T cell therapy is a bit like the America’s Cup Challenge Race Series – one boat/company is ahead and then another is ahead, it’s an ever changing and fluid situation…
In this post, we’re looking at questions from subscribers – so what’s in the July BSB mailbag?
* CAR T Cell Therapy: Is the recent FDA hold – that came and went in record time, a setback to Juno? Who will win the CAR-T race to market in the United States? What is the market opportunity in Europe?
* Jounce/Celgene Deal: Celgene have a reputation for doing deals with innovative biotech companies, but then what? Is the Jounce deal a good one, or is it a value destroyer?
There are a few other questions in the mail bag, but the above gives you a flavour of some of the commentary in this post.
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Aloha! The Eddie Aikau Big Wave surf contest only happens on Waimea Bay on the North Shore of Oahu in a year when there are 40 ft swells. It’s six years since the last one took place.
Waimea Bay Surfing on Feb 10th 2016
Yesterday, at the last minute the big waves failed to show up as an expected storm took a different track.
In R&D terms this is a bit like a phase 3 trial that was expected to be positive, only at the last minute reads out negative.
Last year was an exceptional year in multiple myeloma with several new approvals. It was a “Grand Cru” year, but there is already another wave on the horizon…
Whether it’s a 40 foot Eddie Aikau wave remains to be seen, just like the bay and weather dictates the waves, clinical trial data and physician experience ultimately drive uptake.
This post continues our in-depth post-ASH analysis and pre-TANDEM coverage, with a look at the new wave in myeloma that’s coming our way.
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Aggressive lymphoma… the very phrase is enough to send chills down your spine!
In 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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The ASCO 2014 annual meeting starts on Friday in Chicago and there’s some interesting Multiple Myeloma (MM) data that we’ll be covering.
This preview outlines which MM data may be noteworthy at ASCO and for those going, I’ve included the session times and locations so you can mark your dance card accordingly. There will be more on the potential commercial implications of the data once they have been presented.
Although ASCO is mainly considered a solid tumour meeting, it has not been without some excellent data on hematologic malignancies over the years.
ASCO will always have a particularly soft spot for me since we launched imatinib (Gleevec) for advanced CML on the Friday of ASCO way back in 2001. Many readers may know that I was in new products at Novartis Oncology and was heavily involved in bringing STI571, as it was originally known, to market and subsequently moved on to the brand team.
The meeting happened in a blur; on Friday we shipped drug for the first scripts the same day within hours of approval received that morning, flew to the conference, had a packed hall with standing room only for 2,000 people in a CME session in the afternoon, presented the one-year phase 3 IRIS data on the Monday, and received a very nice mention from Dr David Scheinberg (MSK), one of the phase 2 trialists during the Sunday plenary session. All these events occurred only a few days after hitting the front page of TIME magazine. It took quite a few weeks to come down from that incredible high!
When people insist ASCO is a solid tumour meeting, I always smile and remember that isn’t always the case.
Hematologic malignancies can generate excellent data mid year. This year, there is good news to discuss, not in CML, but multiple myeloma (MM) at both ASCO and at the European Hematology Association (EHA) Congress in Milan from June 12-15. There is also some nice CLL data, which I will cover in a separate preview.
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This year at the American Society of Hematology (ASH) there are over 800 abstracts on multiple myeloma alone. Obviously, one can’t possible do them all justice, but there are a number of important ones that are well worth highlighting, especially given the raft of new products in development, as well as some solid data from existing approved products.
Myeloma has long been dominated by proteasome inhibitors and immunomodulatory (IMiD) agents in combination with prednisone, dexamethasone, melphalan or as a triplet such as RVd, VMP etc. In Europe, melphalan still dominates as part of the base therapy, while in the US, dexamethasone (dex or simply d) is preferred partner since the tolerability is much improved along with a lower risk for secondary primary malignancies (SPMs).
In this detailed preview, the following companies and products are covered:
Companies: Millennium, Celgene, J&J, Amgen, Novartis, GSK, Array, Actelion, Biotest, KaloBio, Curis, Verastem, Karyopharm, Aeterna Zentaris.
Products: Ixazomib, lenalidomide, pomalidomide, carfilzomib, panobinostat, daratumumab, ibrutinib, CC-292, afuresertib, GSK2857916, ARRY-520, ACY-1215, indatuximab ravtansine, CUDC-907, VS-5584, selinexor, LCL161, BYL917, perifosine.
I also discuss some controversial topics such as lack of overall survival in the Revlimid trials and the risk of cardiovascular adverse events with Kyprolis. There are also an exciting raft of new compounds with new targets in various stages of development.
Obviously there will be more to come at the meeting, but for now, there’s plenty to discuss and review ahead of time.
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