Biotech Strategy Blog

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

Posts tagged ‘ASH 2014 Carfilzomib’

Coit Tower San FranciscoThe 2014 American Society of Hematology (ASH) annual meeting starts later this week in San Francisco. #ASH14 is a “must attend” given the innovation that has taken place in recent years for new treatments of blood related cancers.

One of the highlights of last year’s ASH was the data for CTL019 Chimeric Antigen Receptor CAR-T in children with acute lymphoblastic leukemia (ALL) presented by Stephan Grupp (CHOP). The data, in the opinion of many, was worthy of presentation in the plenary session of the meeting.

CAR-T cell therapy remains in the news, with the recent announcement that Seattle based Juno Therapeutics have an initial public offering (IPO) planned, and last week Kite Pharmaceuticals announced a secondary offering to raise additional funds. Last month, Houston based Bellicum Pharmaceuticals also filed an IPO to raise funds for development of their GvHD and CAR-T therapies.

It already looks a highly competitive marketplace and nobody is yet in phase 3 development. In addition to Juno, Kite, Novartis/UPenn and Bellicum, the Chinese also have CAR-T therapies in development. Other companies in the field include Cellectis, who have partnerships with Servier and Pfizer. On top of all this activity, only a week ago Janssen announced they had partnered with Transposagen Biopharmaceuticals. Wow!

In addition to ALL, CLL, and NHL, new developments are starting to emerge in myeloma, not just with CAR T cell therapies, but also checkpoint inhibitors and modified measles virus therapy.

Investor interest in immuno-oncology is certainly very high, and one has to question whether it is beginning to border on “tulip mania”? As we’ve written about on the blog, there remain a number of challenges that have to be overcome with CAR-T therapy, particularly in adults, and at the moment it’s still very much an experimental therapy.

In this post, we offer some top line thoughts on what to expect and look out for at ASH14 in Multiple Myeloma. It is consistently an area that attracts a lot of interest at the meeting and this year promises not to disappoint.

If you have to plans to be in San Francisco, do say “hello.”

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This week Amgen announced that their second generation proteasome inhibitor, carfilzomib (Kyprolis), had met the primary endpoint of progression free survival (PFS) in the phase III ASPIRE trial. This study compared the triple combination of Kyprolis plus Revlimid and low dose dexamethasone (KRd) to the doublet of Revlimid plus low dose dexamethasone (Rd) in relapsed/refractory multiple myeloma. The overall survival (OS) is not yet mature and statistical significance was not been reached at the interim analysis. We will have to see how that data is looking in a few months time at the American Society of Hematology (ASH) meeting in December.

This is an important trial because the data will enable Amgen to file for approval of carfilzomib in Europe with the survival data. The PFS for the two groups (26.3 vs. 17.6 months) showed a clear benefit in favour of adding carfilzomib to standard therapy by 8.7 months:

“Results from the ASPIRE study will form the basis for regulatory submissions through­out the world beginning in the first half of 2015.”

Allowing time for CHMP approval and country reimbursement, this means that carfilzomib will possibly be available in 1H16 in Europe.

What impact will this data have on the multiple myeloma landscape?

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