December 8, 2010
MMRF Newsflash from ASH, Vol. 2, Anne Quinn Young, MPH
The Multiple Myeloma Research Foundation (MMRF) team continues to report from the American Society of Hematology (ASH) Annual Meeting in Orlando. The Annual ASH Meeting featured several dozen abstracts on next-generation treatments for the treatment of multiple myeloma. Below are a few highlights of the data presented over the past few days:
- Encouraging results of a Phase II study of carfilzomib, a next-generation proteasome inhibitor that was facilitated by the MMRC, were presented by Dr. David Siegel. Of 257 patients evaluated in the study, patients had an overall response rate of 24% to carfilzomib and a median duration of response of more than 7 months. Notably, no patients discontinued treatment due to either new or worsening peripheral neuropathy. A separate analysis of patient responses revealed that patients who had high-risk features such as chromosome 13 deletions, deletion of chromosome 17p and/or translocations of chromosomes 4 and 14 or chromosomes 14 and 16 had similar response rates. Based on these positive results, Onyx, the manufacturer, expects to file for FDA approval sometime in 2011. Meanwhile, a Phase III trial comparing carfilzomib-Rev-dex to Rev-dex is open and accruing patients.
- New data from several trials involving the exciting new IMiD pomalidomide were also presented. The trials, conducted in the US (one of which was conducted through the MMRC) and in France, included patients who were refractory to both Velcade and Revlimid - patients who are in urgent need of new treatment options. Regardless of the dose schedule under study, at least 30% of patients receiving 4 mg in each trial responded to therapy. There was no evidence of the incidence or worsening of peripheral neuropathy. A Phase III trial is expected to open in early 2011.
- The novel therapy Zolinza (vorinostat), a histone deacetylase inhibitor, continues to appear to be a promising new option for myeloma patients in combination with standard therapies like Velcade (bortezomib) and Revlimid (lenalidomide). Poster presentations revealed compelling, but early, data on Zolinza in combination with Velcade and/or Revlimid, both for newly diagnosed and for relapsed/refractory patients. Excitingly, one trial, conducted in part through the MMRC, found it could re-sensitize Velcade-resistant patients to the combination of Velcade and Zolinza. This combination drug is being studied in a Phase III trial and, if the results are promising, it could be FDA-approved for myeloma as early as 2012.
- The results of a Phase II study of elotuzumab in combination with Revlimid and dexamethasone, a trial that advanced from an earlier MMRC study, were presented. Although treated patients had not previously received Revlimid, the ORR was 28 percent, and 23 percent in patients receiving 10 or 20 mg/m2, respectively. This is a very early study, but the results are encouraging. Additional data on early studies of elotuzumab plus Rev-dex, as well as elotuzumab plus Velcade-dex, both of which were advanced through the MMRC, show similarly encouraging data. A Phase III clinical trial comparing elotuzumab-Rev-dex to Rev-dex is expected to open early next year.
By the end of the week audiocast highlights from the meeting will be available, featuring the expert commentary of Dr. Sagar Lonial of Emory University and of Dr. David Siegel of the University of Hackensack Medical Center. This will be followed by a live teleconference in mid-January (stay tuned for details!) and a detailed report of findings from the meeting in the February 2011 issue of FOCUS, the MMRF's bi-annual newsletter.