The big news yesterday evening was that Amgen’s phase III FOCUS trial in relapsed/refractory multiple myeloma failed to meet its primary endpoint of overall survival (HR=0.975).
Such a marginal hazard ratio (HR) tells us that the risk of death was not reduced by taking carfilzomib over best supportive care.
According to the company:
“The 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide. Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.”
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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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Chicago – it’s day 4 of the ASCO (American Society of Clinical Oncology) annual meeting. Sunday at ASCO can be a bit hit or miss depending on whether the plenary selection committee makes a good choice in which studies to give the “glory” and how interesting they are. It’s certainly been a busy meeting, although I have to say going round the poster halls has been a horrible experience.
For the first time this year, they doubled up the trials in progress posters, which makes it like a rugby scrum to reach the QR code to get a copy, and all it means is that people use smaller text to cram the same material into a smaller area. People do want to talk people about what’s going on, the rational for trials and it must be a miserable experience for presenters to be faced with such cramped conditions. Memo to ASCO – it was not a good idea and the new poster numbering layout is really hard to follow. It’s not as if there is a shortage of space.
Yesterday afternoon was an afternoon of plenary data. It was interesting to see leading breast cancer physician and influential ASCO member Robert Miller (@RSM2800) question the choice on Twitter:
While I completely agree with the need to publish negative data so that researchers in the field can better understand what happened and learn how to design trials better or differently, that is after all what science is about, I do question whether EVERYONE at ASCO needs to know that. An oral presentation of the ALTTO trial data in a breast cancer session would have been sufficient to achieve that goal. I personally thought the PREVAIL trial data from enzalatumide in advanced prostate cancer prior to chemotherapy was more worthy of plenary recognition than a negative data breast cancer trial. The PREVAIL data was published in the New England Journal of Medicine yesterday.
There were other data worthy of plenary recognition and we’ll be writing them up on the blog. So what’s on the agenda for today? Subscribers can login below to read more.