Today’s events began with 7:30 am oral presentations on multiple myeloma therapies (excluding transplants, which came later in the afternoon). Highlights from the oral presentation during the day included:
- Revilmid®/VELCADE®/dexamethasone (RVd) + Panobinostat (Pano) for newly diagnosed patients (remember, Pano is only approved for relapsed patients) demonstrated a 46% near complete response (nCR) / complete response (CR) in a phase I/II trial. This compares favorably with RVd alone, which typically results in 10 to 20% CR in previous trials.
- Minimal Residual Disease (MRD) in complete response (CR) patients post-maintenance in the French RVd +/- Stem cell transplantation (SCT) + Rev for one-year maintenance therapy showed MRD-negative for 83% of patients and 17% MRD-positive post-maintenance. Remember these were all patients deemed to be in CR! That’s why the sensitivity of MRD testing will become a more important test to determine our myeloma response.
- The same aforementioned French study, which compares the stem cell transplantation (SCT) arm to the non-SCT arm (although patients can cross over to the SCT arm) announced results for the first time. Specifically, the SCT arm showed better progression free survival (PFS), that is 43 months as opposed to 34 months. However, it also showed similar results of three-year overall survival (OS), that is 81% as opposed to 83%. So is early transplant better? I say, we still don’t know for a couple of reasons: 1) Three-year OS is likely not long enough to show a difference; and 2) this study (called DETERMINATION) is also being done in the US. The US-study is identical to the French study, except maintenance therapy is continued until progression, instead of just one year of maintenance therapy. Perhaps the longer maintenance therapy will show the non-SCT arm being just as effective.
- Long-term results of an SCT versus Cytoxin-Rev-Prednisone saw that complete response (CR) and very good partial response (VGPR) results were very close at the start of consolidation, yet MRD-negative was much better for the SCT arm (48% as opposed to 28%).
- I found another MRD analysis quite interesting, concluding that while both MRI and PET-CT scans can provide benefit at diagnosis, the PET-CT after treatment is a better prognosticator for progression free survival and overall survival; this is because it correlates more closely with MRD testing.
During the rest of the day 1 had a variety of activities:
- Attended a SWOG meeting (one of the cancer groups that develops trials) for which I’m a patient advocate and offer a patient’s perspective when new clinical trials are proposed.
- Attended a meeting by Takeda discussing product information about their new oral proteasome inhibitor Ninlaro (Ixazomib). How to remember the brand name Ninlaro? Well, the internal designation for this drug was MLN9708. So Ninlaro is “Nine” without the “e” and “oral” spelled backwards. What can I say . . . give it a try. A couple of recommendations that I gathered about Ninlaro (of course, consult your myeloma doc first!): take one hour before or two hours after eating. The dosage is 4 mg on days 1, 8, and 15 of a 28-day cycle. If you miss a dose, go ahead and take it if it’s within 72 hours; otherwise wait till the next scheduled dose.
- I checked out posters and thought folks with renal (kidney) issues might find this interesting, having examined a pooled analysis of over 1000 patients, with about one-third having renal insufficiency. These relapsed/refractory patients were given pomalidomide-dexamethasone (POM-DEX) and the results for overall response rate (ORR) was 34% as opposed to 30%; the median PFS results were similar. However, OS was shorter for renal-impaired patients, that is 10.5 months as opposed to 14 months.
Finally, with all the recent products approved by the FDA, I was interviewed by a couple of organizations asking me what patients and caregivers should know about these new products. Of course, with four products receiving FDA approval in 2015, including three in November, patients can’t help but get excited. These products represent new categories of treatment (monoclonal antibodies and HDAC-inhibitors) as well as the convenience of an oral proteasome inhibitor, giving us an expanded arsenal to manage our disease. However, we also need to realize that these approvals come with some restrictions, for example, they are available only for relapsed patients and can be taken in combination with other medications such as Revlimid® plus dexamethasone.
Still, you can’t help but smile.