ASCO 2017: Abstract Recommendations From Dr. Rafael Fonseca—Plasma Cell Disorders
Sunday, June 4, 9:45 AM–12:45 PM
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
8000 Daratumumab (DARA) in combination with carfilzomib, lenalidomide, and dexamethasone (KRd) in patients (pts) with newly diagnosed multiple myeloma (MMY1001): An open-label, phase 1b study. AJ Jakubowiak, A Chari, S Lonial, et al
Take-Home Message
- This study enrolled 22 newly diagnosed patients with multiple myeloma regardless of transplantation eligibility to evaluate the tolerability and efficacy of DARA–KRd. The carfilzomib dose was escalated to 70 mg/m2 in 19 patients by cycle 1 day 15. After a median follow-up of 7.4 months, 6 patients discontinued treatment, 46% of patients reported serious AEs (14% possibly related to DARA), and 18 patients reported a grade 3/4 treatment-emergent AE. DARA–KRd treatment led to 100% 6-month progression-free survival and an objective response rate of 100%, including 5% complete response and 86% very good partial response.
- These results demonstrate the tolerability of adding DARA to KRd and support further studies examining DARA–KRd as a frontline therapeutic option.
8001 Lenalidomide, doxorubicin hydrochloride and dexamethasone versus bortezomib, lenalidomide, and dexamethasone prior to scheduled stem cell transplant in newly diagnosed myeloma. S Knop, C Langer, MM Engelhardt, et al
Take-Home Message
- This study enrolled 476 newly diagnosed patients aged 65 years or younger with multiple myeloma and randomized them to receive lenalidomide, Adriamycin, and dexamethasone (RAD) or bortezomib, lenalidomide, and dexamethasone (VRD) to evaluate induction with each combination. More patients receiving VRD completed all induction cycles (93.2% vs 89.7%), and no significant difference in post-induction CR rate was reported (13.0% vs 11.8%). Negative minimal residual disease was achieved in 22.7% of patients with paired baseline/post-induction samples. Treatment-emergent serious AE frequency was similar in both groups (RAD 20.3%; VRD 14.8%).
- Post-induction CR rates were comparable between the two treatment combinations, with acceptable tolerability, requiring follow-up data to evaluate time-dependent endpoints.
8002 An open-label, single arm, phase IIa study of bortezomib, lenalidomide, dexamethasone, and elotuzumab in newly diagnosed multiple myeloma. J Laubach, AK Nooka, C Cole, et al
Take-Home Message
- This phase IIa study enrolled 41 newly diagnosed, transplant-eligible patients with multiple myeloma to evaluate the safety and efficacy of elotuzumab combined with lenalidomide, subcutaneous bortezomib, and dexamethasone. Of 29 patients with evaluable response data, the overall response rate was 100% after four cycles, with 29% achieving a partial response, 47% achieving a very good partial response, and 24% achieving a complete response. Frequently reported grade 3 or higher toxicities included hypophosphatemia (12%) and thrombocytopenia (15%). A total of 2 deaths were reported, due to respiratory failure and complications of septicemia.
- These data demonstrate the efficacy of elotuzumab combined with lenalidomide, subcutaneous bortezomib, and dexamethasone in newly diagnosed patients with multiple myeloma. Although the rate of grade 3 or higher toxicities was low, there were two grade 5 events.
Monday, June 5, 8:00 AM–11:30 AM
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
8009 Lenalidomide induction and maintenance therapy for transplant eligible myeloma patients: Results of the Myeloma XI study. GH Jackson, F Davies, C Pawlyn, et al
Take-Home Message
- This study enrolled 2042 transplant-eligible myeloma patients who underwent induction randomization to lenalidomide (CRD) or thalidomide (CTD) plus cyclophosphamide and dexamethasone to determine the optimal immunomodulatory induction and maintenance regimen. Deeper responses were reported with CRD induction compared with CTD induction (60% vs 53%), and CRD was associated with significantly improved progression-free survival (35.9 vs 32.9 months) and 3-year overall survival (82.9% vs 77.0%). A significantly longer median progression-free survival was reported with lenalidomide maintenance therapy compared with observation. Exploratory analysis revealed that CRD induction with lenalidomide maintenance was optimal.
- CRD resulted in improved responses and outcomes compared with CTD, with the best outcomes associated with lenalidomide induction plus lenalidomide maintenance.
8010 Response status as predictor of survival after autologous hematopoietic cell transplant (AHCT), without or with consolidation (with bortezomib, lenalidomide (Len) and dexamethasone) and len maintenance (AM vs. ACM) versus tandem AHCT and len maintenance (TAM) for up-front treatment of patients (pts) with multiple myeloma (MM): BMT CTN0702-stamina (NCT01109004). G Somlo, MC Pasquini, B Blackwell, et al
Take-Home Message
- This study enrolled 758 patients with MM who were randomized to melphalan and AHCT (AM; n = 257), tandem melphalan AHCT (TAM; n = 247), or melphalan AHCT and four cycles of RVD (ACM; n = 254) to identify the best strategy leading to longer progression-free survival. Progression-free survival at 38 months was similar, with no association found between baseline response and progression-free survival. An adverse association for progression-free survival and overall survival was found for high-risk category.
- No association of baseline response with survival outcomes was found, warranting further study evaluating whether complete response/minimal residual disease following treatment is associated with survival outcomes.
8011 Minimal residual disease (MRD) monitoring by multiparameter flow cytometry (MFC) in newly diagnosed transplant eligible multiple myeloma (MM) patients: Results from the EMN02/HO95 phase 3 trial. S Oliva, D Hofste op Bruinink, L ŘÍhová, et al
Take-Home Message
- This study included 316 patients with MM who were evaluable before maintenance and received bortezomib-cyclophosphamide-dexamethasone (VCD) induction, intensification with bortezomib-melphalan-prednisone (VMP) vs high-dose melphalan (HDM) followed by stem cell transplant, consolidation with bortezomib-lenalidomide-dexamethasone (VRD) vs no consolidation, and lenalidomide maintenance. Minimal residual disease (MRD) analysis was assessed by multiparameter flow cytometry, revealing that 76% of patients were MRD-negative, with 64% of these patients receiving HDM and 36% receiving VMP. Significantly longer 3-year progression-free survival was reported in MRD-negative patients compared with MRD-positive patients (77% vs 50%). High-risk cytogenetic was the most significant risk factor.
- The results demonstrate that minimal residual disease is a prognostic factor for patients with MM; lenalidomide improved depth of response.
8014 Natural history of t(11;14) multiple myeloma (MM). A Lakshman, MA Moustafa, SV Rajkumar, et al
Take-Home Message
- Data from 366 patients with multiple myeloma who had t(11;14) by FISH and 732 age- and period-matched controls without t(11;14) were retrospectively evaluated to investigate outcomes. After a median-follow up of 56.9 months, 57.1% of patients with t(11;14) were alive. The median time to first progression or death was 23.1 months, and the median overall survival was 78.6 months in patients with t(11;14). The median survival of 83.8 months was comparable in the controls. Using a Cox-proportional hazards model, age >70 years, ISS III vs ISS I/I, and high-risk cytogenetic (HRC) vs no HRC or t(11;14) were associated with reduced overall survival. Importantly, the risk for reduced overall survival was not significantly different between patients with t(11;14) without HRC and those without t(11;14) or HRC.
- Advanced stage at diagnosis, advanced age, and HRC were significantly associated with worse overall survival in these patients.
8015 Pembrolizumab (Pembro) plus lenalidomide (Len) and low-dose dexamethasone (Dex) for relapsed/refractory multiple myeloma (RRMM): Efficacy and biomarker analyses. EM Ocio, M-V Mateos, RZ Orlowski, et al
Take-Home Message
- This study included patients with relapsed/refractory multiple myeloma who received pembrolizumab plus lenalidomide and low-dose dexamethasone to determine the potential for synergistic antitumor activity. Patients were a median age of 61 years with a median four lines of prior treatment. The most common grade 3 or higher treatment-related adverse events were anemia, thrombocytopenia, and neutropenia, with 2 deaths due to hepatic failure and ischemic stroke. Immune-related adverse events were reported in 5 patients. The overall response rate was 50% in evaluable patients and 38% in lenalidomide-refractory patients. All patients with flow cytometry–evaluable bone marrow aspirate were PD-L1+, but PD-L2 expression was variable. Circulating HLA-Dr+, central, and effector memory CD8+ T cells significantly increased at cycle 2, day 1, whereas naïve CD8+ T cells significantly decreased.
- These results demonstrate the acceptable safety and activity of pembrolizumab plus lenalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, including patients who are lenalidomide-refractory.
8018 Carfilzomib-associated cardiovascular adverse events: A systematic review and meta-analysis. AJ Waxman, SC Clasen, AL Garfall, et al
Take-Home Message
- This systematic review and meta-analysis evaluated 514 trials and included 25 trials with a total of 2623 patients with MM to investigate the incidence and nature of cardiovascular adverse events with carfilzomib. A significant incidence of cardiovascular adverse events, including arrhythmia, ischemia, hypertension, and heart failure, has been associated with carfilzomib. High-grade cardiac AEs were significantly associated with longer duration of infusion, carfilzomib doses ≥45 mg/m2, and phase II/III studies.
- These results suggest that phase I studies may be under-detecting cardiovascular AEs, warranting further studies to identify high-risk patients, develop appropriate monitoring strategies, and investigate treatment options for decreasing risk.
8019 Evaluation of an oral direct anti-Xa anticoagulant, apixaban, for the prevention of venous thromboembolism in patients with myeloma treated with IMiD* compounds: A pilot study (MYELAXAT). B Pegourie, G Pernod, L Karlin, et al
Take-Home Message
- This study enrolled 104 patients with myeloma treated with IMiD compounds to assess the risk of venous thromboembolism and bleeding following administration of apixaban 2.5 mg/day for 6 months. An asymptomatic proximal DVT and a symptomatic distal DVT were reported. Only 1 major and 11 clinically relevant non-major hemorrhages were reported.
- Preventive apixaban was found to be safe and efficient for preventing venous thromboembolism in patients with myeloma treated with IMiD compounds.
8023 Impact of t(11;14) on outcomes in African American (AA) and non-AA (NAA) patients (Pts) with newly diagnosed multiple myeloma (NDMM): Connect MM registry. C Gasparetto, R Abonour, S Jagannath, et al
Take-Home Message
- Data from 3011 patients with newly diagnosed multiple myeloma who completed induction and were tested for t(11;14) were evaluated to determine survival outcomes in African American (AA) and non–AA patients. The proportion of patients who were t(11;14)-positive was similar between groups. AA patients with t(11;14) had shorter PFS compared with patients without t(11;14). AA patients with t(11;14) also had a significantly higher risk of death compared with AA patients without t(11;14) and a higher early morality rate than non-AA patients. No differences in PFS or OS were found in non-AA patients based on t(11;14). The association between race and t(11;14) had a significant effect on overall survival.
- The results demonstrate that t(11;14) may be a risk factor for poor prognosis.
8024 MOR202 with low-dose dexamethasone (Dex) and in combination with pomalidomide/dex and lenalidomide/dex in relapsed or refractory multiple myeloma (RRMM): Interim analysis of a phase I/IIa dose-escalation study. M Raab, M Chatterjee, H Goldschmidt, et al
Take-Home Message
- This interim analysis of a phase I/IIa dose-escalation study included data from 4 patients with relapsed/refractory MM in clinically relevant cohorts treated with MOR202 + dexamethasone (n = 18), MOR202 + lenalidomide/dexamethasone (n = 15), and MOR202 + pomalidomide/dexamethasone (n = 11) and evaluated the safety, maximum tolerated dose, and recommended phase II dose of MOR202. Grade 3 or higher adverse events were mainly hematological, with 2 patients discontinuing due to MOR202-related grade 4 thrombocytopenia and grade 3 acute kidney failure. Grade 1 or 2 infusion-related reactions were reported in 3 patients, mainly during the first infusion. The maximum tolerated dose of MOR202 was not reached. Responses were observed in 29% of patients receiving MOR202 + dexamethasone, 85% of patients receiving MOR202 + lenalidomide/dexamethasone, and 56% of patients receiving MOR202 + pomalidomide/dexamethasone. The longest response duration was 17 months, observed in the MOR202 + dexamethasone cohort.
- These results demonstrate the safety, tolerability, and promising preliminary efficacy of MOR202 in heavily pretreated patients with relapsed/refractory MM.
8025 Daratumumab, lenalidomide, and dexamethasone (DRd) vs lenalidomide and dexamethasone (Rd) in relapsed or refractory multiple myeloma (RRMM): Efficacy and safety update (POLLUX). NJ Bahlis, P Moreau, H Nahi, et al
Take-Home Message
- Here, updated safety and efficacy data were evaluated from POLLUX, which was a randomized phase III study of daratumumab, lenalidomide, and dexamethasone (DRd) vs lenalidomide and dexamethasone (Rd) in relapsed/refractory MM. After a median follow-up of 17.3 months, patients receiving DRd exhibited significantly prolonged progression-free survival (not reached vs 17.5 months) and a significantly higher overall response rate (93% vs 76%) compared with patients receiving Rd. DRd also elicited higher rates of deep responses, including minimal residual disease negativity that was more than threefold higher compared with Rd. Follow-up for overall survival is ongoing, with events reported in 14% of patients receiving DRd and 20% of patients receiving Rd. Updated safety and efficacy data based on 25-month follow-up will be presented.
- DRd elicited significant improvements in progression-free survival, response rates, and minimal residual disease negativity compared with Rd, and the favorable safety profile was maintained over longer follow-up, further validating the use of DRd in pretreated patients with relapsed/refractory MM.
8027 Pomalidomide (POM) + low-dose dexamethasone (LoDEX) after lenalidomide (LEN)-based second-line (2L) treatment (Tx) in patients (Pts) with relapsed/refractory multiple myeloma (RRMM): Analysis of progression-free survival (PFS) by level of disease control. D Siegel, GJ Schiller, KW Song, et al
Take-Home Message
- This study included 51 patients with MM and second-line lenalidomide-based failure who received pomalidomide + low-dose dexamethasone to evaluate overall response rate. Of these patients, 39 discontinued treatment. After a median follow-up of 13.6 months, the overall response rate was 29.4% and the median time to response was 1.9 months, with 66% of patients exhibiting ongoing responses at 1 year. Minimal response was achieved in 15.7% of patients, who exhibited similar treatment durations as patients achieving partial responses or better. The median progression-free survival was 13.8 months.
- These results demonstrate the safety and efficacy of pomalidomide + low-dose dexamethasone in patients with relapsed/refractory MM who have failed second-line lenalidomide-based therapy.
8028 Phase 3 ELOQUENT-2 study: Extended four year follow-up (FU) of elotuzumab plus lenalidomide/dexamethasone (ELd) vs Ld in relapsed/refractory multiple myeloma (RRMM). S Lonial, MA Dimopoulos, KC Weisel, et al
Take-Home Message
- This study included 646 patients with relapsed/refractory MM who were randomized to elotuzumab + lenalidomide/dexamethasone (ELd; n = 321) or lenalidomide/dexamethasone (Ld; n = 325) and followed for 4 years to evaluate survival outcomes and response rates. More patients remained on therapy in ELd vs Ld at data cut-off, with discontinuation mainly due to disease progression in both arms. Patients receiving ELd had a reduced risk of progression/death and relative improvement of 50% in progression-free survival compared with patients receiving Ld. Patients with very good partial response or better exhibited the greatest reduction in progression/death risk. Frequently reported AEs included vascular diseases, cardiac disorders, infections, and second primary malignancies. Although the overall rates of infection and second primary malignancies were higher in patients receiving ELd, patients had longer exposure to ELd and there were fewer deaths compared with Ld.
- These results demonstrate durable and clinically relevant improvement in progression-free survival with ELd, and safety data consistent with previous findings, with minimally increased AEs with the combination.
8030 Cost effectiveness of carfilzomib (CAR), ixazomib (IXA), elotuzumab (ELO), or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) vs LEN+DEX in relapsed/refractory multiple myeloma (R/R MM). N Alsaid, A McBride, AB Agarwal, et al
Take-Home Message
- A network meta-analysis and Bücher method were used to indirectly estimate progression-free survival (PFS) efficacy of patients with relapsed/refractory MM receiving carfilzomib, ixazomib, elotuzumab, or daratumumab with lenalidomide and dexamethasone, vs lenalidomide/dexamethasone. Similar hazard ratios were calculated, which indicated superiority of daratumumab /lenalidomide /dexamethasone over other triplet combinations based on PFS. Incremental cost-effectiveness and cost utility ratios were also calculated for PFS life years (PFS LY) and quality-adjusted life years (QALY) gained. All triplet combinations were associated with increased QALY and PFS LY compared with lenalidomide/dexamethasone, with additional cost. Superior incremental cost-effectiveness and cost utility ratios were calculated for daratumumab /lenalidomide /dexamethasone compared with other triplet combinations.
- Daratumumab /lenalidomide /dexamethasone was shown to have superior PFS efficacy associated with cost-effectiveness and cost utility in patients with relapse/refractory MM.
8034 Impact of metformin use in the outcomes of multiple myeloma patients post stem cell transplant. N Duma, JV Aguilera, J Paludo, et al
Take-Home Message
- This retrospective study evaluated data from 687 patients with multiple myeloma who underwent stem cell transplant (SCT) to assess the clinical effect of metformin. Of these patients, 11.4% were using metformin at the time of diagnosis, with a median metformin dose of 2000 mg daily and a 22-month median duration of use from diagnosis. After SCT, patients using metformin achieved significantly higher rates of complete response compared with patients not using metformin (41% vs 29%). Patients using metformin demonstrated significantly longer median PFS (31.3 vs 16.6 months) and a nonsignificant increase in overall survival (170 vs 106 months) compared with patients not using metformin.
- These results demonstrate improved progression-free survival and complete response rates following SCT in patients using metformin, warranting larger studies.
8037 CALGB/ECOG 100104 (Alliance) study: Lenalidomide (LEN) vs placebo (PBO) maintenance (maint) after stem cell transplant (SCT) for patients (pts) with multiple myeloma—Overall survival (OS) and progression-free survival (PFS) adjusted for treatment (tx) crossover (XO). PL McCarthy, SA Holstein, S-H Jung, et al
Take-Home Message
- This study randomized 231 patients with MM who had undergone stem cell transplantation (SCT) to lenalidomide maintenance and 229 patients to placebo maintenance, with 76 patients without progressive disease crossing over to lenalidomide after a median time from randomization of 11.5 months. Adjusting for crossover, the relative treatment effect for progression-free survival and overall survival increased for lenalidomide vs placebo.
- These results demonstrate the improved treatment effect of lenalidomide vs placebo maintenance after SCT for progression-free survival and overall survival.
8038 Daratumumab-based combination therapies (DCT) in heavily-pretreated patients (pts) with relapsed and/or refractory multiple myeloma (RRMM). A Lakshman, JP Abeykoon, S Kumar, et al
Take-Home Message
- Data were reviewed from 130 patients with relapsed/refractory MM who received at least one cycle of daratumumab-based combination therapies (DCT) with dexamethasone and bortezomib (n = 25), lenalidomide (n = 34), pomalidomide (n = 53), or other (n = 18). The median time to first response was 3.1 months, and the overall response rate was 46%, with a minimal response observed in 17% and a clinical benefit rate of 62%. The median follow-up from initiation of DCT was 5.5 months, with a median duration of response of 6.1 months. The median progression-free survival for patients receiving DCT with bortezomib, lenalidomide, pomalidomide, and other were 3.9, 7.8, 4.6, and 3.9 months, respectively. Median overall survival was not reached. For quadruple refractory patients (n = 28), the median progression-free survival was significantly shorter compared with that experienced by other patients (2.8 vs 5.9 months). Hematological toxicities of grade 3 or higher were reported in 42% of patients.
- These results demonstrate that DCT are effective in patients with relapsed/refractory MM, but less so in quadruple refractory patients, highlighting the challenges of managing this subgroup.
8044 Racial differences in abnormalities by FISH in minorities with multiple myeloma: A single-center experience. MG Velez, VJ Restrepo, N Duma, et al
Take-Home Message
- In this study, CD-138–selected FISH was performed on 799 consecutive patients with multiple myeloma to investigate race-based differences of FISH abnormalities. Of the 482 eligible patients, 71% were white, 10% were Hispanic, 10% were black, 3% were Asian, and 3% were another race. No significant differences in FISH abnormalities were reported among the minorities. Compared with minorities, whites had significantly more abnormalities in IGH rearrangements and t(11;14); however, no significant differences were observed between whites and minorities with high-risk FISH abnormalities.
- These results demonstrate the existence of biological racial disparities in minorities with multiple myeloma, warranting further studies to elucidate the effects on outcomes and risk stratification.
8046 Trends in survival and costs among US multiple myeloma patients. EM Maiese, K Evans, B-C Chu, et al
Take-Home Message
- Data from 5199 patients with MM diagnosed in 2006–2010 and 2011–2014 were examined for trends in survival and healthcare costs. A 35% lower risk of death was found for patients diagnosed in 2011–2014 compared with 2006–2010. Patients diagnosed in 2011–2014 also had 26% higher MM-related monthly per-patient costs and 18% higher all-cause costs compared with patients diagnosed in 2006–2010.
- Survival of patients with MM has improved at a greater rate than healthcare costs have increased, which may be due to changes in overall disease management.
TPS8051 Phase 1 study to evaluate the safety and efficacy of immunotherapy with tremelimumab and durvalumab in multiple myeloma patients receiving high dose chemotherapy and autologous stem cell transplant (HDT/ASCT) + peripheral blood lymphocyte (PBL) reinfusion. AM Lesokhin, DJ Chung, HJ Cho, et al
Take-Home Message
- This ongoing multicenter, open-label phase I study includes patients with MM at high risk for relapse and evaluates the safety and preliminary efficacy of immunotherapy with tremelimumab and durvalumab with autologous peripheral blood lymphocyte (PBL) reinfusion.
- Safety, objective response rate, minimal residual disease, progression-free and overall survival, and 100-day ASCT-related mortality will be evaluated.
TPS8052 CheckMate 602: An open-label, randomized, phase 3 trial of combinations of nivolumab, elotuzumab, pomalidomide and dexamethasone in relapsed/refractory multiple myeloma. S Lonial, PG Richardson, DE Reece, et al
Take-Home Message
- This open-label phase III study will randomize 406 patients with relapsed/refractory MM to nivolumab plus pomalidomide /dexamethasone or to pomalidomide /dexamethasone to evaluate the safety and efficacy of the combination. Nivolumab combined with elotuzumab /pomalidomide /dexamethasone will be evaluated in an exploratory arm. Objective response rates and progression-free survival are the primary endpoints.
- The results will describe potential clinical benefit related to combining elotuzumab with nivolumab and pomalidomide /dexamethasone in patients with relapsed/refractory MM.
TPS8053 A phase Ib study of atezolizumab (atezo) alone or in combination with lenalidomide or pomalidomide and/or daratumumab in patients (pts) with multiple myeloma (MM). HJ Cho, C Cole, TG Martin, et al
Take-Home Message
- This study will enroll patients with relapsed/refractory MM at 19 US sites to evaluate the safety and efficacy of atezolizumab alone, in combination with lenalidomide, or in combination with pomalidomide with or without daratumumab. Primary endpoints include overall response rate and the RP2D of the combinations.
- Duration of response, progression-free survival, safety, pharmacokinetics, and relationships between biomarkers and efficacy endpoints will be evaluated.
TPS8054 Durvalumab (DURVA) plus daratumumab (DARA) in patients (pts) with relapsed and refractory multiple myeloma (RRMM). PG Richardson, W Bensinger, KC Weisel, et al
Take-Home Message
- This study will enroll approximately 144 patients with relapsed/refractory MM to evaluate the safety and preliminary efficacy of durvalumab plus daratumumab with or without the addition of pomalidomide plus low-dose dexamethasone. A 3 + 3 safety run-in phase to confirm the recommended phase II dose tolerability will be included.
- Treatment will continue until progression or unacceptable toxicity. Currently, 6 patients are enrolled in the run-in phase.
TPS8055 A phase 1/2 study of durvalumab (DURVA) in combination with lenalidomide (LEN) with or without dexamethasone (DEX) in patients (pts) with newly diagnosed multiple myeloma (NDMM). S Lonial, A Oriol, M-V Mateos, et al
Take-Home Message
- Up to 138 patients with newly diagnosed MM from the US, Canada, and Europe will be enrolled to evaluate the safety and preliminary efficacy of durvalumab in combination with lenalidomide, with or without dexamethasone.
- Each cohort will enroll 6 patients in the dose-finding phase, with the optimal regimen determined from the dose-finding phase and a parallel dose-expansion phase including up to 40 patients per cohort. Currently, 15 patients are enrolled.
TPS8056 Phase 2, open-label study of venetoclax in combination with carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma. O Bueno, T Xu, J Cordero, et al
Take-Home Message
- This phase II open-label study has a target enrollment of 40 patients with relapsed/refractory multiple myeloma from 10 to 15 US sites and will evaluate the safety and tolerability of the combination of venetoclax, carfilzomib, and dexamethasone. Secondary objectives include examination of pharmacokinetics, preliminary efficacy, and minimal residual disease in bone marrow.
- The goal is to demonstrate the safety and tolerability of the combination and to determine appropriate doses of venetoclax and carfilzomib to use with dexamethasone.
TPS8057 A phase III, randomized, open-label study of isatuximab (SAR650984) plus pomalidomide (Pom) and dexamethasone (Dex) versus Pom and Dex in relapsed/refractory multiple myeloma. PG Richardson, M Attal, J San Miguel, et al
Take-Home Message
- This multicenter phase III study will include approximately 300 patients with relapsed/refractory MM and disease progression who will be randomized to receive isatuximab in combination with pomalidomide and low-dose dexamethasone or pomalidomide/dexamethasone alone to evaluate the clinical benefit of isatuximab. Treatment will continue until unacceptable toxicity, disease progression, or discontinuation.
- The primary endpoint is progression-free survival, with secondary endpoints of overall response rate and overall survival.
Monday June 5, 8:00 AM–11:30 AM
Session: Developmental Therapeutics—Immunotherapy
3010 First-in-human multicenter study of bb2121 anti-BCMA CAR T-cell therapy for relapsed/refractory multiple myeloma: Updated results. JG Berdeja, Y Lin, NS Raje, et al
Take-Home Message
- This multicenter phase I dose-escalation study included 11 patients with relapsed/refractory MM and evaluated the safety and efficacy of the CAR T-cell modality bb2121. As of data cut-off, no neurotoxicities or cytokine release syndrome of higher than grade 2 or dose-limiting toxicities were reported. Grade 1/2 cytokine release syndrome was reported in 73% of patients. The overall response rate in 6 evaluable patients treated with doses of 15.0 x 107 or higher was 100%. Data based on additional follow-up and additional patients will be presented.
- These results demonstrate the promising safety and efficacy of bb2121 and support the use of bb2121 as a new treatment paradigm in this patient population.
TPS3102 Nivolumab in combination with daratumumab, with or without pomalidomide and dexamethasone, for relapsed/refractory multiple myeloma: 2 cohorts of the phase 1 CheckMate 039 safety study. AM Lesokhin, S Kumar, MA Popa McKiver, et al
Take-Home Message
- This phase I safety study includes patients aged 18 years and older with relapsed/refractory MM and at least two prior therapies who are treated with nivolumab monotherapy or in combination with daratumumab, with or without pomalidomide and dexamethasone.
- Adverse events, minimal residual disease, overall response rates, duration of response, and progression-free survival will be evaluated.
Monday June 5, 1:15 PM to 4:15 PM
Session Developmental Therapeutics—Immunotherapy
LBA3001 Durable remissions with BCMA-specific chimeric antigen receptor (CAR)-modified T cells in patients with refractory/relapsed multiple myeloma. F (Xiaohu) Fan, W Zhao, J Liu, et al
Monday June 5, 1:15 PM to 4:45 PM
Session: Health Services Research, Clinical Informatics, and Quality of Care
6522 Closure of Medicare Part D coverage gap by the Affordable Care Act (ACA) and use of oral anti-myeloma agents. AJ Olszewski, S Dusetzina, AJ Davidoff, et al
Take-Home Message
- This retrospective study using the SEER-Medicare database included 3313 Part D enrollees to examine the effects of the ACA-mandated 50% manufacturer discount on brand-name drug prices for IMiD. Of these patients, 41% received IMiDs for treatment. Following the ACA policy, the median gross IMiD cost of the first prescription increased for all patients, whereas out-of-pocket costs for the first prescription and the first year of IMiD therapy decreased for patients not receiving low-income subsidies. Furthermore, the percentage of patients requiring catastrophic coverage for the first IMiD prescription decreased from 71% to 49%. The ACA discount did not significantly affect the percentage of patients treated with IMiDs or the time from diagnosis to first prescription.
- These results demonstrate that this ACA-mandated discount policy lowered out-of-pocket costs for Part D enrollees with MM treated with IMiDs, but this policy may be insufficient to ameliorate the financial barrier for those who do not receive low-income subsidies.
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Additional Info
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