Day 2: A busy day at ASH
December 2, 2018
Today I attended oral presentations from 8 a.m. to 6 p.m. with a few short breaks to check out posters and exhibits as well as meet with Pharma companies. Let me discuss several findings from several oral presentations (#abstract).
Maintenance Therapy with Ninlaro (Ixazomib)….Tourmaline 3 study
After a transplant, Ninlaro (an oral proteasome inhibitor) was given 3 times per week for 2 yrs versus a placebo. You might be asking “Why, since most patients already get Revlimid for maintenance?” But did you know 30% of Rev maintenance pts discontinue Rev due to adverse side effects? So can Ninlaro be effective in the setting and provide pts with about option? Well, compared to placebo maintenance, Ninlaro improved PFS by 39% (26.5 vs 21.3 mos). And after the SCT, MRD- was the same in both arms but then 12% of Ninlaro pts converted to MRD- versus 7% for the placebo arm. These aren’t huge benefits but certainly an improvement to MM pts in maintenance with no other options. Perhaps Rev-Ixa will be given together in this setting but that can also be costly.
Venetoclax with Carfilzomib & Dex for Relapsed/Refractory Patients
We heard a couple of years ago that Venetoclax (oral med) was particularly effective in multiple myeloma patients with t(11;14) translocation. But what about other patients? In this trial, 42 Cfz-naive pts (only 8 with t(11;14)) were given this regimen. The overall response rate (ORR) for the whole group was 79% (including complete response of 38%). And it should be noted that all 8 t(11;14) patients achieved an ORR. So VenKd may well be a useful regimen for all R/R pts.
Dose-adjusted Rd-R vs Continuous Rd for Newly Diagnosed Frail Multiple Myeloma Patients
This phase 3 study showed that after 9 cycles of Rev(25)-dex followed by less Rev (10mg), this treatment is just as effect as continuous Rev(25)-dex.
Initial Results of Phase 1 Study bb21217 CAR-T Therapy
This study was presented by Dr. Nina Shah (UCSF), but results were very early. She reported on the first 12 pts where 8 of 12 experienced CRS but only 1 grade 3 and no grade 4. And neurotoxins was only experienced by 3 of 12. All received 150 x 10-6 BCMA-engineered T-cells. So ASE’s we’re manage but next dosage levels are at 450, 800 and 1200 for the additional 40 pts. Response included 3 sCR/CR’s, 6 Very Good Partial Responses (VGPRs), and 10 or 12 patients achieved ORR. Up to 9 mos T-cell persistence and 4/4 evaluable patients all achieving MRD negative status (MRD-). All in all, good initial results, but it’s far too early to make any conclusions.
I attended this most recent oral in lieu of hearing Tom Brokaw speak so check other blogs for feedback on his talk.
Wishing you the best of health!