Biotech Strategy Blog

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

Posts tagged ‘Ixazomib’

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.

Surfing Waimea Bay

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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This year has been an unprecedented Grand Cru year for the field of multiple myeloma, with no less than four drugs approved by the FDA to date… the fourth one just this morning while writing this preview!

  • Panobinostat (Farydak) in relapsed/refractory disease in combination with bortexomib plus dexamethsone after at least 2 prior therapies.
  • Daratumumab (Darzalex) received accelerated approval based on phase 2 data and is human CD38-directed monoclonal antibody that is indicated for the treatment of patients who have received at least three prior lines of therapy.
  • Ixazomib (Ninlaro) is the first oral proteasome inhibitor and is approved in combination with lenalidomide plus dexamethasone, in people who have received at least one prior treatment.
  • Elotuzumab (Empliciti) is a monoclonal antibody against CS–1/SLAMF7 approved today in combination with lenalidomide plus dexamethasone after 1–3 lines of prior therapy.

There are also many promising new agents in development and quite a few that may well not make it to market as a result of newer, better tolerated agents coming through.

To learn more about our insights on multiple myeloma, subscribers can log in or you can sign up below to read our latest ASH 2015 Preview.

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.

Subscribers and those wishing to read the in-depth review by subscribing can click through the Tinypass box below to sign in or sign up – check it out!

I’m not a great fan of Twitter lists, especially those that imply you are a “Top Cat,” because they can end up being divisive and generate resentment in those not included.

ASH Logo picture credit: Pieter DroppertThat said, without wishing to offend anyone, here’s my initial starting point of those I will be following at the 2012 annual meeting of the American Society of Hematology in Atlanta from December 8 – 11 (#ASH12):

American Society of Hematology


Patient Advocacy

Companies /Industry Execs

Physicians/Researchers & Institutions

This is not intended to be a definitive list, so I encourage you to watch the #ASH12 Twitter stream for additional people to follow depending on your interests. I have intentionally not included PR folks, investors, journalists who are usually too busy writing their own stuff and exhibitors who just want to tweet their own news. However, if I have missed anyone who has a burning desire to be included, please contact me.

Wifi permitting (always a big IF since many conference venues have not invested sufficiently in infrastructure to cope with demand) I’m hoping there will be a good Twitter conversation in Atlanta.

One of the hot topics this year is Multiple Myeloma, for which there are four “Super Friday” satellite symposia and over 700+ abstracts.

Earlier this year, the FDA approved Onyx’s carfilzomib (Kyprolis) and approval for Celgene’s pomalidomide (Actimid) is expected by year-end.  Several other new agents are on the horizon including Millennium’s new proteasome inhibitor ixazomib/MLN9708 that Dr Sundar Jagannath discussed at the recent Chemotherapy Foundation Symposium in New York. The availability of new treatment options is certainly good news for patients.

I am looking forward to attending the ASH education session on Keeping Pace with Advances in Myeloma. Hope to see you there if you have plans to be in Atlanta next week.


New treatments for multiple myeloma (MM) are changing the treatment landscape and that is set to continue over the next few years as several new products come to market.

This year we have seen the FDA approval of subcutaneous bortezomib (Velcade®) and carfilzomib (Kyprolis®). Approval for pomalidomide is anticipated soon.

Earlier this week at the 2012 Chemotherapy Foundation Symposium in New York, Sundar Jagannath, M.D., Professor of Medicine at Mt. Sinai School of Medicine presented on “New IMiD and Proteasome Inhibitors.”

Dr Jagannath told a large audience at the Symposium (also known as the Greenspan Meeting) that he hoped “pomalidomide will get accelerated approval and be in your hands by New Year”

In his presentation, Jagannath discussed some of the new products in development. One that he mentioned in detail was MLN9708/ixazomib (Millennium), a new reversible, oral proteasome inhibitor currently in early clinical trials.

He noted that is not just being developed as a single agent in advanced disease, but is already being tested in combination with lenalidomide and dexamethasone therapy in earlier settings.

Companies with MM drugs in the pipeline will need to look closely as to how the treatment landscape may change in the next few years if new products such as ixazomib are approved and replace existing products such as bortezomib.

Although Dr Jagannath’s talk was very informative from a new product development perspective, I did wonder whether some of the community medical oncologists in the audience, who only see a few myeloma patients, might have benefitted from a more practice orientated perspective.

I sat next to a community oncologist from Florida, for example, who told me he found the MM treatment regimens difficult to understand for the few patients that he saw.

Dr Jagannath concluded his presentation with the thought that “rapid strides in genomics promises new drugs and personalized medicine in the near future.”

I look forward to hearing more about the latest research in Multiple Myeloma at the annual meeting of the American Society of Hematology (ASH 2012) in Atlanta next month.

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