653. Myeloma: Therapy, excluding Transplantation: New Approaches in the Treatment of Relapsed/Refractory Plasma Cell Discrasias
Conclusion cited from the abstract: Treatment with ixa-Dex significantly prolonged duration of composite survival and vital organ function, PFS, and time to subsequent therapy vs physician’s choice. Moreover, ixa-Dex resulted in an improved CR rate and DOR and, although the primary endpoint of hematologic response was not met, all clinically relevant time-to-event endpoint data favored ixa-Dex vs physician’s choice. Ixa-Dex was generally well tolerated and associated with a doubling of treatment duration vs physician’s choice; no new safety signals were seen. TOURMALINE-AL1 is the first phase 3 trial in RRAL to show significant outcome improvements, suggesting ixa-Dex represents a new option for RRAL pts, who have limited access to therapies.
Conclusion cited from the abstract: Emerging data show that across the 4 dose levels tested, SC TAK-079 induced ORR in 43% of these heavily pretreated patients with no infusion reaction, no drug-related lymphopenia or thrombocytopenia, 4% rate of drug-related infections, and 11% drug-related anemia. TAK-079 SC has a low treatment burden with the low volume (2 mL) subcutaneous injections performed in ≤ 1-minute signifying the potential for home-based self-administration. The high potency of TAK-079 may result from selective binding to myeloma cells (ie less binding to RBC and platelets). Updated safety, efficacy, pharmacodynamics, and PK data for this heavily pre-treated RRMM population will be available for presentation at the meeting.
Christine I Chen, et al.
Conclusion cited from the abstract: The all oral SPd combination is durable and active with an ORR of 58% in patients with disease that is lenalidomide refractory and pomalidomide naïve compared to previously published data of 31% ORR for pomalidomide/dexamethasone in a similar patient population. The median PFS on SPd of 12.2 months in pomalidomide naïve patients is longer than that observed with pomalidomide/dexamethasone (<4 months). No unexpected adverse events were noted. Selinexor QW demonstrated a manageable side effects with ≤2% Grade 3/4 nausea, vomiting, diarrhea, weight decreased and decreased appetite suggesting that the side effects of selinexor are a function of the dose and schedule. This observed activity and manageable side effect profile with QW selinexor in combination with pom/dex supports further studies.
Simon Harrison, et al.
Conclusion cited from the abstract: Adding Ven to Bd demonstrates significant efficacy in pts with RRMM harboring either t(11;14) or tumor cells expressing high levels of BCL2. The benefit-risk profile appears to be favorable in these subsets of pts and additional studies to gain further safety and efficacy information are warranted.
Luciano J. Costa, et al.
Conclusion cited from the abstract: CC-93269, a 2+1 BCMA TCE, shows a manageable safety profile and promising efficacy, including MRD-negative sCRs, in pts with heavily pretreated RRMM. The study continues to enroll in the dose escalation phase. Updated safety and efficacy data will be presented at the meeting.
Sikander Ailawadhi, et al.
Conclusion cited from the abstract: CLR 131 is a unique, first in class targeted radiotherapeutic for RRMM. Preliminary data for CLR 131 administered as a fractionated dose shows an acceptable and expected safety profile in this patient population. Fractionated dosing at 37.5 mCi/m2 has shown an efficacy signal and has been adopted as the standard for CLR 131 dosing in ongoing and future trials. Dose escalation to determine the highest tolerated dose is ongoing in the Phase 1 study and is currently examining a fractionated infusion of 40 mCi/m2 administered as 20 mCi/m2 CLR 131 on day 1 and day 7 (± 1 day). Based upon these data enrollment to the fractionated 37.5 mCi/m2 cohort of the Phase 2 trial continues.