Before presenting my ASH summary, I’ll mention a late-breaking abstract presentation that I attended early this morning focused on different transplant regimens. This was a large trials (750 newly diagnosed multiple myeloma patients) randomly divided into three arms. Arm 1, denote ACM, received one autologous stem cell transplant (ASCT), four cycles of Velcade-Revlimid-dexamethasone consolidation, then Rev maintenance until progression. Arm 2, denoted TAM, received a tandem (two) SCT’s and Rev maintenance until progression. Finally, Arm 3, denoted AM, received a single auto SCT, then Rev maintenance until progression.
Like me, you may be surprised to learn that after 38 months, the progression free survival (PFS) (57% / 56% / 52%) and overall survival (OS) (86% / 82% / 63%) were comparable in all three groups. Furthermore, when looking at subgroups such as high-risk multiple myeloma patients, there was no differences (all about 24% PFS and 75% OS). Even overall secondary primary cancers (SPMs) were all about 5%. And yet, earlier I saw a European trial result that showed Tandem SCT benefitted high-risk patients over other transplant regimens. Why the difference? I don’t really know. Are 38 months long enough to make these conclusions? European transplant induction is typically 4–6 months, whereas the US is more like 3–4 mos. Maybe longer induction replaces the value of consolidation?
Here’s my preliminary summary of ASH 2016, and I emphasize “preliminary” because I’ll be learning more about the interpretation ASH 2016 results as I listen to follow-up presentations by multiple myeloma expert oncologists over the next 1–2 months. Truthfully, after late drug approvals in 2015, I didn’t expect much at ASH 2016, but I was wrong.
- There were several interesting new drugs, specifically Nelfinivar, Selinexor, and Venetoclax, some which showed best results when the patient’s multiple myeloma contained a particular biomarker such as t(11;14) for Venetoclax.
- There was considerable focus on high-risk multiple myeloma patients and the importance of including Velcade as part of induction, consolidation, and maintenance.
- In addition to the late-breaking abstract discussed above, transplants had lots of coverage at ASH. Probably the most impressive transplant results I saw was using Kyprolis-Rev-Dex (KRd) before and after an SCT which resulted in >80% CR for both standard and high-risk multipme myeloma, and excellent PFS, OS and MRD- .
- Speaking of Minimal Residual Disease (MRD), this was included in 45 Myeloma abstracts. While it’s come a long way as an analytical tool for multiple myeloma response, it’s still not ready for prime-time outside of clinical trials. And even in clinical trials, I don’t believe MRD is established yet as a surrogate marker for OS, and thus being used as a Primary Endpoint, which would result in faster completion of trials.
- And the future? Immunotherapy is high on the list, including more monoclonal antiboidies (mAbs), as well as newer treatment categories such as checkpoint inhibitors, CAR-T therapies, and vaccines. There’s certainly lots of research and studies necessary before these newer immunotherapy treatments are ready for multiple myeloma patients, but they may very well be part of a bright future for us.
So the best recommendation I can make is for you are to stay educated and consider participation in clinical trials because that how myeloma treatments are advanced. Wishing all of you the best of success!