It was a long day today with meetings beginning at 7am and ending at 6pm. There were a couple of 1-2 hr breaks in the middle that provided me time to check out posters. And then tonight I attended a Journalist Workshop where MM experts Drs. Durie, Moreau, Richardson and Orlowski presented ASH highlights to the US and International Press that was translated real-time into 4 other languages and also streamed on-line. So let me provide some of today's results working my way backwards.
At the press meeting, the doctors were asked about the most significant announcements at ASH. The various drugs getting the most attention (and well-deserved) were Carfilzomib and Pomalidomide. Maybe you've heard of these and the hope is they'll receive FDA approval in 2012. However, you may not have heard of Elotuzumab (humanized monoclonal antibody) or MLN9708 (oral proteasome inhibitor) which also received positive marks.
Dr. Durie also noted that the treatment paradigm has changed since 10 years ago when novel drugs such as Thalidomide and Velcade started appearing. In the past a patient would receive a limited cycle of drugs, get a transplant or not, and see how they do. Today continuous therapy (at least fairly long-term) is becoming the model. A patient receives induction therapy, a transplant or not, possibly consolidation treatment followed by maintenance. And while it's not known how long maintenance should last, trials are being done for 1-yr, 2-yrs, 3-yrs or even "time to progression" (till your MM becomes active again).
Some exciting trial results presented today include:
- The oral proteasome inhibitor MLN9708 in Relapsed/Refractory MM pts in a Phase I trial showed about a 13% ORR (<= Partial Response) and 60% stable disease as a single agent.
- Elotuzumab, which doesn't really have much MM activity on its own, is combined with Rev-dex in a Phase II trial of R/R MM pts and shows a 92% ORR (14% CR) whereas Rev-dex alone showed about 60% ORR for the same type of patients.
- In the completion of a Phase III trial, Melphalan+Prednisone+Rev followed by Rev maintenance for newly diagnosed older (non SCT eligible) pts showed ORR of 79% and after 4 years, the median Overall Survival (OS) has not yet been reached. Remember, this is an older patient base.
- BTW, in the same elderly population, Vel-Thal maintenance after VMP or VTP showed 46% CR and median OS not yet reached at 5 years.
- Several Carfilzomib (Cfz) studies were presented:
- CfzRd for newly diagnosed showed ORR = 100% after several cycles;
- Cfz-only for R/R MM pts (not having taken Velcade) showed ORR 42-52%
- Several Pomalidomide (Pom) results were also presented:
- Pom-Cytoxin-Prednisone for R/R MM pts showed ORR 66%;
- Pom-Biaxin-Dex for R/R MM pts showed ORR 60%;
- Pom-Dex for R/R MM pts (75% refractory to both Vel and Rev) showed 32% ORR with little difference among various refractory groups
And still there was more with drug such as Perifosine, Panobinostat, Vorinostat as well as other combinations.
That's it for Monday's sessions highlights from my perspective. The show ends tomorrow and I'll try to put up one final post after I return home.Jack Aiello