Happy New Year!
Immunotherapy treatment for multiple myeloma has been around for several decades, first in the form of stem cell transplantation, then augmented by the addition of IMiD immune modulation drugs such as thalidomide, lenalidomide or pomalidomide. In due course, along came immune checkpoint blockade in solid tumours and it was only a matter of time before they would be evaluated in hematologic malignancies, albeit with mixed results.
The proteasome inhibitors and IMiDs are unlikely to go away any time soon, but other targets have also emerged including CD38, SLAMF7/CS1, BCMA/APRIL, PD–1/L1 and a few others that are being currently investigated in the clinic.
Where does this leave us and what looks really promising?
In our latest thought leader interview undertaken at the recent American Society of Hematology (ASH) meeting in Atlanta, we asked a global expert for his candid views and were not surprised at some of the hard hitting comments that emerged from the in-depth discussion of several key issues…
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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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Orlando – the 2015 annual meeting of the American Society of Hematology (Twitter #ASH15) kicks off in earnest today at the Orange County Convention Center.
There’s a comprehensive press program at #ASH15, which will no doubt drive a lot of the media coverage, but in addition to discussing some of the highlights, we’ll be going off the beaten path, and gathering noteworthy data for our post-meeting coverage.
There’s always a lot of great posters at the meeting, as well as useful educational and scientific sessions.
If you are interested in checkpoints in hematology, do check out the Scientific Session chaired by Dr Krishna Komanduri (@drkomanduri) “Checkpoint, Please?” It takes place from 9.30 am to 11 am today. It’s repeated again from 4 to 5pm on Sunday.
As the conference program notes, “this session will provide a broad overview of checkpoint inhibition and its therapeutic potential in the setting of solid tumors, alloreactivity and treatment of hematologic neoplasms.”
This is a rolling blog post, throughout the day we’ll be adding commentary as the opportunity presents.
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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.
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Multiple myeloma (MM) has been very much in the news this week after the American Society of Clinical Oncology (ASCO) abstracts were released to much anticipation.
Myeloma is largely thought to be an incurable disease despite the option of an autologous stem cell transplant for newly diagnosed patients. That said, I have actually met some people who have had two or 3 transplants over several decades, a testament to their strength and fortitude in enduring such a challenging procedure.
This year, the news media have focused on elotuzumab (BMS/AbbVie), a CS1/SLAMF7 inhibitor that has previously shown clinical activity in earlier trials, after it was showcased in the ASCO Presscast last week. This why you see many articles on the data reported from this particular abstract.
It’s not the most exciting new data in this disease for me though, that honour goes to two other therapeutics of an entirely different kind. They come completely out of left field and what we saw over the last two months really caught our attention and may surprise you too.
Indeed, we saw hints of some of this data at the American Society for Gene and Cell Therapy (ASGCT) meeting last week in New Orleans.
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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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