Glucocorticoid Receptor News

«1 2...415 416 417 418 419420421 422 423 424 425...1067 1068 »

|||||||||| Jakafi oral (ruxolitinib) / Novartis, Incyte
Efficacy and Safety of Ruxolitinib and Steroids for Treating Patients with Relapsed or Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4369;
P1
Specifically, RUX blocks expression of Mucin 1 whose function is linked to lenalidomide (LEN) resistance, downregulates PD-L1 and PD-L2 expression and reduces tumor stimulatory M2 macrophage polarization in multiple myeloma (MM) bone marrow...The treatment was well tolerated and shows promising efficacy for treating heavily previously treated MM patients. Because of this, additional studies are being conducted with higher doses of RUX in combination with MP for this patient population.

|||||||||| Ninlaro (ixazomib) / Takeda
Extended Characterization of Newly Diagnosed Multiple Myeloma (NDMM) Patients with In-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib Proteasome Inhibitor (PI) Therapy in the Community-Based United States (US) MM-6 Study: Updated Efficacy and Safety, and Reasons for Premature Discontinuation (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4368;
P4
Over 80% of US MM-6 patients were aged >65 years and most had ≥1 comorbidity prior to study entry. The rate of patients discontinuing within 4 cycles of i CT (7 cycles of PI-based therapy in total) is concerning because these patients may not receive the full benefit of long-term PI-based treatment.

|||||||||| Darzalex IV (daratumumab) / J&J, Xpovio (selinexor) / Karyopharm
Single Cell RNA Sequencing in Patients Enrolled in a Selinexor Clinical Trial Reveals Overexpression of Alternative Nuclear Export Pathways Associated with Resistance to Selinexor in Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4367;
P2, P2b
Here we report scRNA-seq analysis of PCs from patients with advanced refractory MM (aRRMM) (n=21) enrolled in an ancillary sub-study of a prospective clinical trial (XPORT-MM-028, NCT04414475), treated with selinexor combined with dexamethasone (Xd, in penta-refractory MM n=7), or with bortezomib, dexamethasone (XVd, in triple-class refractory [TCR] MM n=9), 5 patients participated in the ancillary study only...Protein-protein interaction enrichment analyses revealed mRNA splicing and capping as well as nucleocytoplasmic transport as up-regulated modules in the refractory patients potentially serving as a resistance mechanism for blockade of XPO1 mediated nuclear export by selinexor. In summary, our study defines a roadmap for combining single cell RNA-seq profiling with clinical trials to stratify patients according to their level of anti-MM drug resistance, to define new biomarkers for drug resistance that may support personalized therapeutic decisions and reveal potential novel targets.

|||||||||| Darzalex IV (daratumumab) / J&J
Daratumumab Plus Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) in Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts): A Subgroup Analysis of Griffin (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4365;
P2
sCR rates were improved for D-RVd versus RVd in pts ≥65 years but not in pts with ISS stage III disease or high cytogenetic risk. Improved MRD-negativity rates were observed for D-RVd in all subgroups.

|||||||||| Darzalex IV (daratumumab) / J&J
Daratumumab (DARA) Improves Outcome in High Risk Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4364;
Conditioning for tandem autologous stem cell transplantation (ASCT) was with fractionated melphalan (50mg/m 2 x4) (fMEL) based on prior observations that patients with adverse cytogenetics fare better with fMEL rather than single high dose MEL200mg/m 2...The 2 nd ASCT was followed by further immunological consolidation with DARA (16mg/k) for 2 doses, and maintenance therapy for 3 yrs with 3-months block of alternating DARA-KD (DARA 16mg/kg day 1; K 36mg/m 2 and dex 20mg weekly) and DARA-lenalidomide (R)D (DARA 16mg/kg day 1; R 15mg day 1-21 q28 and D 20mg weekly)...These results point to improved outcome when incorporating DARA into the treatment for high risk MM with no undue safety signals. In addition, DARA did not hamper adequate collection of stem cells.

|||||||||| Ninlaro (ixazomib) / Takeda
Ixazomib Based Maintenance Therapy for the Patients with Newly Diagnosed Multiple Myeloma in Real-World Practice (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4359;
Conclusion Although there are certain differences in maintenance treatment options for newly diagnosed multiple myeloma patients in real-world practice, the results of our retrospective study support that the ixazomib-based maintenance therapy was effective with acceptable toxicity and single-agent ixazomib maintenance provided enough clinical benefit compared to two or three agents. Keywords : multiple myeloma, ixazomib, maintenance therapy, real-world practice

|||||||||| Darzalex IV (daratumumab) / J&J, Ninlaro (ixazomib) / Takeda
Follow-up Analysis of Ixazomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Routine Clinical Practice (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4357;
Our follow-up analysis confirmed the impact on OS in patients in the whole cohort including relapse 1-3. The median PFS2 was also longer in the IRD cohort, possibly affected by more frequent use of monoclonal antibodies in the next treatment.

|||||||||| Darzalex IV (daratumumab) / J&J, Soliris (eculizumab) / AstraZeneca
Mutations in the Alternative Complement Pathway in Multiple Myeloma Patients with Carfilzomib-Induced Thrombotic Microangiopathy (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4349;
Regimens included carfilzomib-dexamethasone (Kd, 7 patients), carfilzomib-lenalidomide-dexamethasone (KRd, 1 patient), carfilzomib-pomalidomide-dexamethasone (KPd, 1 patient), and carfilzomib-daratumumab-dexamethasone (DaraKd, 1 patient)...Carfilzomib was discontinued in all patients and five patients were treated with plasma exchange (PLEX) while one patient received eculizumab...In the setting of carfilzomib use, heterozygous CFHR3-CFHR1 deletion may represent a risk factor for the development of TMA. Our data set the bases for larger studies assessing complement mutation as a predisposing factor for PI-induced TMA.

|||||||||| Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Tracking Daratumumab Clearance Using Mass Spectrometric Approaches: Implications on M Protein Monitoring and Reusing Daratumumab (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4348;
The most common regimen used was daratumumab, bortezomib and dexamethasone (23%); 26% underwent transplant after daratumumab-based induction...There was no association between the time to disappearance of daratumumab by MASS-FIX and old age ≥70 (RR: 0.9, P=0.81], male gender (RR: 0.9, P=0.60), eGFR 2weeks) (RR: 1.0, P=0.97), treatment duration (<200 days vs ≥200 days) ( RR: 1.0, P=0.95), or transplantation status (RR: 1.0, P=0.98)...Proteinuria is associated with earlier disappearance of daratumumab by MASS-FIX and may have implications in patients with amyloidosis and monoclonal immunoglobulin deposition disease (MIDD). Further studies are needed to identify additional factors associated with the timing of disappearance.

|||||||||| Darzalex IV (daratumumab) / J&J
Detection of Double Hit and Triple Hit Cytogenetics at Relapse Identifies a Very High Risk Subset of Relapsed/Refractory Multiple Myeloma Patients (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4347;
Bortezomib based therapy was used in 5 patients and 4 patients received Carfilzomib based therapy...DISCUSSION The outcome of DH/THM at relapse is associated with an aggressive presentation and poor outcomes in the real-world setting. These patients are candidates for early aggressive or novel therapy or clinical trials.

|||||||||| Ninlaro (ixazomib) / Takeda
The INSURE Study (INSIGHT MM, UVEA-IXA, REMIX): A Pooled Analysis of Relapsed/Refractory Multiple Myeloma (RRMM) Patients (pts) Treated with Ixazomib-Lenalidomide-Dexamethasone (IRd) in Routine Clinical Practice (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4342;
Our results suggest a benefit of treatment with IRd in earlier vs later lines, consistent with reports from previous, smaller real-world studies of IRd in RRMM pts. In addition, this analysis provides important insights on the effectiveness of IRd in frail pts, helping to increase the understanding of the achievable outcomes in this subpopulation.

|||||||||| Empliciti (elotuzumab) / AbbVie, BMS
Immune Profiles of Myeloma Tumor Microenvironment May Predict Sensitivity or Resistance to Elotuzumab (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4322;
While NK cells are known to be important to the ELO mechanism of action, our data suggests that ELO activity is compromised in the absence of immature NK cells. This work suggests that measurable characteristics of the cellular components of the iTME may provide important cues to help predict ELO therapeutic efficacy.

|||||||||| mezigdomide (CC-92480) / BMS
CC-92480 Enhances Cell-Autonomous Cytotoxicity through Blockade of G2/M Transition When Combined with Bortezomib/Dexamethasone in Pre-Clinical Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4309;
P1/2
Importantly, the combination of either POM or CC-92480 with a PI, like BTZ, does not appreciatively affect single agent MOA. We have also identified a key differentiating mechanism of cell autonomous activity for CC-92480 in combination with BTZ/DEX where MM cells enhance apoptotic induction at the G 2 /M stage compared to POM.

|||||||||| Venclexta (venetoclax) / Roche, AbbVie
Identifying Mechanisms Associated with Venetoclax Resistance in Multiple Myeloma (MM) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4308;
Our study also indicates that upstream signaling involved in BCL2 family regulation during acquired resistance is likely related to cytokine, growth factor, and/or RTK–induced cell signaling such as PI3K. Co-inhibition of MCL-1, or BCLXL, as well as the upstream PI3K, RTK (FGF and EGF), IGF-1 mediated signaling were effective in overcoming VTX resistance.

|||||||||| Empliciti (elotuzumab) / AbbVie, BMS, Darzalex IV (daratumumab) / J&J, Opdivo (nivolumab) / Ono Pharma, BMS
Low Dose Cyclophosphamide in Combination with Elotuzumab - a Novel Immunotherapeutic Strategy for Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4304;
Combining CTX with monoclonal antibody (mAb) therapy has proven beneficial in potentiating relapsed and/or refractory multiple myeloma (RRMM) therapies, with daratumumab-directed MM cell death enhanced in the presence of CTX 2,3...ELO has been approved for use alongside dexamethasone and lenalidomide 4 or pomalidomide (POM) 5...Given the increased expression of PD-1 and CD47, we investigated if the inclusion of nivolumab and anti-CD47 mAbs potentiated ADCC...2020 10:91 Hose et al ., Journal of Cancer Research and Clinical Oncology. 2021; 147:205–212

|||||||||| dexamethasone / Generic mfg.
Genomic Characterization of in Vitro Acquired-Resistance to Proteasome Inhibitors (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4291;
No significant cross-resistance was observed with other therapeutic agents including melphalan, dexamethasone and IMIDs indicating that the observed drug resistance mechanisms are specifically related to PIs...Metabolomic analyzes are currently ongoing for functional validation. Altogether, drug-resistant cell lines represent an attractive preclinical model to test molecules targeting these pathways in order to identify new therapeutic strategies to overcome PI resistance in MM.

|||||||||| dexamethasone / Generic mfg., methotrexate IV / Generic mfg., cisplatin / Generic mfg.
Impact of Choice of Platinum-Based Salvage Therapy on CNS Relapse in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4161;
High-dose cytarabine, used in standard salvage therapy alongside rituximab, dexamethasone, and either cisplatin (R-DHAP) or oxaliplatin (R-DHAX), is known to cross the blood-brain barrier...Conclusion In patients with R/R DLBCL receiving platinum-based salvage therapy, the cumulative incidence of CNS relapse after salvage initiation was not significantly different between patients who received R-DHAP/R-DHAX and those who received other salvage regimens. The lower number of CNS relapses and absence of brain parenchyma relapses in the R-DHAP/R-DHAX group, despite a greater proportion of patients with DHL/THL, suggests that parenchymal penetration by cytarabine may influence the pattern of relapse, warranting study in a larger cohort.

|||||||||| dexamethasone / Generic mfg., cisplatin / Generic mfg.
Diffuse Large B-Cell Lymphoma (DLBCL) Patients with Late Relapses Who Are Transplant-Eligible Have Excellent Outcomes and May Represent Unique Biology (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4131;
These data support the early use of alternative therapies (such as CAR T-cell therapy) in pts with earlier relapse. Correlative studies to delineate the biological diversity of rel/refr DLBCL are underway.

|||||||||| plamotamab (XmAb13676) / J&J
Safety and Anti-Tumor Activity of Plamotamab (XmAb13676), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Subjects with Relapsed/Refractory Non-Hodgkin’s Lymphoma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4125;
P1
CRS was generally manageable with premedication. The study is ongoing with further optimization of dose and schedule.

|||||||||| Adcetris (brentuximab vedotin) / Seagen, Takeda
Brentuximab Vedotin Plus ESHAP (BRESHAP) Versus ESHAP As Salvage Strategy for Patients with Primary Refractory or Relapsed Classical Hodgkin’s Lymphoma. Preliminary Results from the Breselibet Prospective Clinical Trial (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4089;
P2b
BRESELIBET trial is a randomized trial that tries to demonstrate the superiority of BRESHAP vs ESHAP in RRHL as well as the feasibility of a non-transplant option in patients achieving a stringent CR assessed by PET-CT. These initial results provide safety data as possible support for these two hypotheses and the trial enrollment continues.

|||||||||| dexamethasone / Generic mfg.
A Targeted Gene Expression Classifier Identifies Pediatric T-Cell Acute Lymphoblastic Leukemia (T-ALL) Patients at High Risk for End Induction Minimal Residual Disease Positivity (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_4015;
We have developed a gene expression classifier that differentiates a subset of non-ETP T-ALLs with an ETP-like gene expression pattern and a high risk of MRD+, and have adapted the classifier to a clinically tractable targeted platform. Identification of this high-risk subset at diagnosis has the potential to facilitate risk-adapted trials to evaluate the utility of novel or more intensive therapies aimed at improving clinical outcomes.

|||||||||| Venclexta (venetoclax) / Roche, AbbVie, Idhifa (enasidenib) / BMS, Servier, Elzonris (tagraxofusp) / Menarini, Nippon Shinyaku
Outcomes for Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated with Frontline HCVAD-Based Chemotherapy (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3942;
P2
Combination approaches with both targeted and cytotoxic chemotherapy incorporating prophylactic CNS-directed therapy are urgently needed in this disease. These results establish high rates of CR for patients treated with frontline HCVAD, and establish a baseline role still, even in the modern targeted therapy era, for cytotoxic chemotherapy regimens in the treatment of BPDCN; in particular, confirming the role for HCVAD-based chemotherapy for BPDCN.

|||||||||| Blincyto (blinatumomab) / Astellas, Amgen
Blinatumomab Associated Seizure Risk in Patients with Down Syndrome and B-Lymphoblastic Leukemia: An Interim Report from Children’s Oncology Group (COG) Study AALL1731 (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3926;
Seizure prophylaxis may be advisable in DS patients while receiving blinatumomab, particularly those > 10 years of age. Further follow-up and a larger sample size are needed to confirm incidence and identify risk factors predisposing DS patients to neurologic toxicity.

|||||||||| Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
Final Induction Therapy Results of an Open Label Phase II Study Using Inotuzumab Ozogamicin for Induction Therapy, Followed By a Conventional Chemotherapy Based Consolidation and Maintenance Therapy in Patients Aged 56 Years and Older with Acute B-Lymphoblastic Leukemia (INITIAL-1 trial) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3922;
P2
Three cycles of InO as induction therapy for the treatment of elderly patients with acute B-cell ALL results in very high remission rates with MRD-response in up to 90% (MRD negativity or MRD-levels <10 -4 ). The promising EFS and survival rates of these patients warrant further investigation of this novel induction therapy in a prospective randomized trial.

|||||||||| dexamethasone / Generic mfg., thioguanine / Generic mfg.
Effectiveness and Security of a Modified CALGB10403 in Adolescents and Young Adults with Acute Lymphoblastic Leukemia in Low-and-Middle-Income Countries: A Multicentric Experience in Central America (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3904;
After the first interim analysis (October 2019), we replaced the prednisone by dexamethasone during induction...Access to cellular therapies, and BiTes is cost restricted in LMIC. Hence, we should generate strategies to intensify treatment in MRD positive patients and expand transplant access to overcome outcomes.

|||||||||| Aranesp (darbepoetin alfa) / Amgen, Kyowa Kirin
Sars-Cov-2 Infection Associated with Aplastic Anemia and Pure Red Cell Aplasia (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3810;
P2
It is possible that this is co-incidental due to the high prevalence of SARS-CoV-2. However, there is emerging evidence that COVID-19 pneumonia is a hyperinflammatory and immune dysregulated state improved by dexamethasone therapy.

|||||||||| dexamethasone / Generic mfg.
The Safety and Efficacy of Granulocyte Transfusions in Pediatric Recipients with Severe Neutropenia (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3759;
32.4% cleared the infection with granulocyte transfusion. 100 day survival is 85.1%.

|||||||||| pelcitoclax (APG-1252) / Ascentage Pharma
Antitumor Activity of Dual BCL-2/BCL-Xl Inhibitor Pelcitoclax (APG-1252) in Natural Killer/T-Cell Lymphoma (NK/TCL) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3666;
In conclusion, APG-1252 has promising antitumor effects in NK/TCL, either as a single agent or in combination with an HDAC inhibitor or chemotherapy. These findings provide evidence to further evaluate APG-1252 as a potential treatment for NK/TCL.

|||||||||| Gamifant (emapalumab) / SOBI
Safety of Emapalumab in Pediatric Patients with Primary Hemophagocytic Lymphohistiocytosis (HLH): Relationship to Treatment Exposure (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3664;
P=N/A, P2/
Current conventional therapy for HLH is based on immunochemotherapies, namely etoposide and glucocorticoids; this treatment, however, is associated with opportunistic infections and severe myelotoxicity...Emapalumab was initiated at a dose of 1 mg/kg administered intravenously every 3 days, on a Background of dexamethasone 5-10 mg/kg/day...Conclusion : In this study, the exposure-safety evaluation did not reveal any significant relationships between exposure to emapalumab and observed incidence rates of AEs, serious AEs, infections, or IRRs. These findings support the primary evidence of a favorable benefit-risk profile of emapalumab across the dose range used in this fragile patient population.

|||||||||| Darzalex IV (daratumumab) / J&J
Real-World Patient Characteristics and Treatment Outcomes Among Newly Diagnosed Multiple Myeloma Patients Initiating Daratumumab, Lenalidomide, and Dexamethasone As First-Line Therapy (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3576;
The early trend of PFS is also similar to that in MAIA, with the majority of patients progression free at 6, 9, and 12 months. Greater understanding of long-term outcomes among transplant-ineligible NDMM patients who received D-Rd as first-line therapy at US oncology practices is needed to further facilitate the safe and effective use of daratumumab.

|||||||||| Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Blenrep (belantamab mafodotin) / GSK, Xpovio (selinexor) / Karyopharm
Matching-Adjusted Indirect Comparisons of Efficacy Outcomes in Patients with Relapsed and Refractory Multiple Myeloma for Idecabtagene Vicleucel (KarMMa) Versus Selinexor Plus Dexamethasone (STORM Part 2) and Belantamab Mafodontin (DREAMM-2): Updated Analysis with Longer Follow-up (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3575;
DOR was comparable between ide-cel and BM (HR, 0.86 [95% CI, 0.45–1.65]), while ide-cel extended PFS versus Sd (HR, 0.45 [95% CI, 0.27–0.74]) and BM (HR, 0.45 [95% CI, 0.26–0.76]). Similarly, ide-cel extended OS versus Sd (HR, 0.24 [95% CI, 0.14–0.43]) and BM (HR, 0.51 [95% CI, 0.29–0.91]) (Figures 1 and 2).

|||||||||| Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Successful Conversion and Implementation to Subcutaneous Daratumumab in Patients with Multiple Myeloma (MM) and Light Chain (AL) Amyloidosis (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3572;
Fourteen patients (24%) received montelukast 10 mg and 19 patients (46%) received famotidine 20-40 mg prior to the dose of SC daratumumab at provider discretion...Furthermore, less aggressive supportive medications can also be used. Integration of the SC formulation yielded significant chair time savings and may have the ability to create a more efficient clinic workflow.

|||||||||| Darzalex IV (daratumumab) / J&J
Patient Characteristics, Treatment Patterns and Outcomes Among Black and White Patients with Multiple Myeloma Initiating Daratumumab: A Real-World Chart Review Study (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3563;
However, Black patients initiated daratumumab later in their treatment, with more than half of Black patients initiating daratumumab in fourth or later line of therapy, and a lower percentage of Black patients had high-risk cytogenetics, suggesting a potential discrepancy in access to new therapies for MM. These findings were observed in a relatively modest sample size, and therefore interpretation warrants caution.

|||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Efficacy Outcomes of Isatuximab with Pomalidomide and Dexamethasone Are Comparable to (ICARIA-MM) Trial Data: Initial Results of a UK-Wide Real-World Study of Relapsed Myeloma Patients (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3561;
It demonstrated encouraging ORR and PFS outcomes in RRMM in the routine care setting, and these were comparable to ICARIA-MM trial data. However, close monitoring and dose adjustments are required to manage toxicities.

|||||||||| Darzalex IV (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
A Matching-Adjusted Indirect Comparison of Isatuximab Plus Carfilzomib and Dexamethasone Versus Daratumumab Plus Lenalidomide and Dexamethasone for Relapsed Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3560;
P3
Individual patient data from IKEMA (lsa-Kd arm, n=179) were matched to aggregate data from the phase 3 POLLUX trial (NCT02076009) (Dara-Rd arm, n=286) by a two-step process. Firstly, POLLUX inclusion criteria (creatinine clearance

|||||||||| hydrocortisone / Generic mfg.
Premedication with Hydrocortisone Increases Risk of Adverse Drug Events and Return to Medical Care Among Pediatric Patients with ITP Treated with IVIG (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3511;
In order to identify rates of IVIG-associated ADEs and subsequent emergent medical evaluations in pediatric patients with ITP, we completed an retrospective observational cohort study of all pediatric patients with ITP who were treated with one-time IVIG infusion utilizing Gamunex-C ® 10% at a dose of 1g/kg across 4 large pediatric centers from 2010 to 2019...No associations were identified between ADE s and gender, race/ethnicity, premedication with diphenhydramine or ondansetron, pre-treatment serum IgG levels, or concurrent glucocorticoid administration...Patients who received premedication with acetaminophen were less likely to develop IVIG-associated ADEs, but those who received premedication with diphenhydramine or concurrent glucocorticoid therapy were no more or less likely to develop ADEs...Patients returning for emergent medical evaluation frequently underwent repeat laboratory studies or CT imaging, resulting in unnecessary radiation exposure and increased healthcare-related costs. These findings will help to inform IVIG premedication strategies in an attempt to reduce both ADEs and re-presentation to medical care among pediatric patients with ITP receiving IVIG therapy.

|||||||||| dexamethasone / Generic mfg., lenalidomide / Generic mfg.
Prognosis and Therapeutic Response Transfer Learning Model for Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3476;
Comparing therapeutic effects for patients in a real-world hospital setting with clinical trials, we found that lenalidomide + bortezomib + dexamethasone used in a first-line therapy resulted in lower median PFS of 17-47 months than the 39-52 months published in the SWOG S0777 trial, most likely because comorbidities contributed to shortening the PFS in real-world settings. We conclude with an analysis of concrete examples where therapeutic recommendations differ from guidelines, explaining the reason with statistically significant cohorts observed in the data.

|||||||||| dexamethasone / Generic mfg.
Supermobilizers with High CD34+ Cell Collection for Autologous Transplant and Impact on Survival Outcomes in Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3426;
Most pts (422/605; 70%) received high dose dexamethasone (HDD) alone or in combination with vincristine and adriamycin (VAD) for pre-transplant induction therapy (pre-dating the novel agent era) with only 18% (110/605) receiving more contemporary bortezomib-based induction (mostly cyclophosphamide, bortezomib and dexamethasone; CyBORD). The median number of CD34 + cells collected for all pts was 13.9x10 6 /kg (range 2.1-61.8).

|||||||||| ciltacabtagene autoleucel (LCAR-B38M) / J&J
Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed By Ciltacabtagene Autoleucel Versus Vrd Followed By Lenalidomide and Dexamethasone (Rd) Maintenance in Patients with Newly Diagnosed Multiple Myeloma Not Intended for Transplant: A Randomized, Phase 3 Study (CARTITUDE-5) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3424;
P3
However, ASCT, which includes a standard melphalan conditioning regimen that is associated with systemic toxicity, is not always feasible due to various reasons including advanced age, co-morbidities, and pt frailty...In the cilta-cel arm, pts will undergo apheresis and receive two more 21-d cycles of VRd as bridging therapy; pts will then be administered cilta-cel (target dose: 0.75×10 6 CAR+ viable T cells/kg) 5–7 d after lymphodepletion chemotherapy (intravenous cyclophosphamide 300 mg/m 2 and fludarabine 30 mg/m 2 daily for 3 d) followed by a tx-free observation phase...Results from this study will provide insights into the efficacy and safety of VRd followed by cilta-cel in pts with NDMM. Additionally, VRd tx followed by a single infusion of cilta-cel vs continuous tx with Rd until disease progression may offer pts the benefit of a tx-free period.

|||||||||| dexamethasone / Generic mfg., lenalidomide / Generic mfg., carfilzomib / Generic mfg.
Curative Strategy (GEM-CESAR) for High-Risk Smoldering Myeloma (SMM): Carfilzomib, Lenalidomide and Dexamethasone (KRd) As Induction Followed By HDT-ASCT, Consolidation with Krd and Maintenance with Rd (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3418;
Melphalan at dose of 200 mg/m 2 followed by ASCT was given as intensification therapy followed by two KRd consolidation cycles and maintenance with R at dose of 10 mg plus dexamethasone at dose of 20 mg weekly for up to 2 yrs. These results suggest that early treatment with intention to abrogate risk of progression in transplant candidate high risk SMM patients is associated with a 94% PFS at 55 months and a sustained MRD negative rate at 1 year post treatment of 67%.

|||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
Impact of Corticosteroids on Efficacy of BCMA Targeted CAR-T Therapy in Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3343;
There may be an impact on PFS and TTNT when the total time on steroids is ≥ 5 days. Future larger studies are needed to examine the effect of steroid exposure and duration on BCMA CAR-T efficacy.

|||||||||| Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
Icans Prophylaxis with Simvastatin and Intrathecal Dexamethasone in Adults Receiving Axicabtagene Ciloleucel (Axi‐Cel) Treatment (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3328;
P1
One passed away prior to apheresis due to disease progression and was non-evaluable. Table 1 shows the patient characteristics.

|||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
CD19 CAR-T Cell Therapy in Children with Relapsed and Refractory B-ALL (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3321;
All patients received prophylactic tocilizumab before CAR-T cells infusion...Patients with low leukemia burden received the same lymphodepletion chemotherapy as in the first part of the trial, and a single fixed dose of CAR-T cells at 1x10 6 /kg b.w. Patients with high leukemia burden received an escalated lymphodepletion (fludarabine 120 mg/m 2 , cyclophosphamide 750 mg/m 2 , cytarabine 900 mg/m 2 , etoposide 450 mg/m 2 , dexamethasone 30 mg/m 2 ) and a divided dose of CAR-T...The proposed risk-adapted strategy of CAR-T dosing allows to achieve high remission rate in all patients (with high and low leukemic mass). HSCT is likely to be a necessary modality for consolidation and long-term maintenance of remission after CAR-T therapy among a majority of patients with advanced B-ALL.

|||||||||| dexamethasone / Generic mfg.
A Preliminary Study on the Safety and Efficacy of a Novel Human BCMA-Targeting CAR-T Therapy in Patients with Relapsed/Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3319;
16.6% (4/24) was administrated with dexamethasone to relieve symptoms, with the total dose less than 20 mg, while nobody was treated with IL-6 receptor antagonist...The CAR-T treatment of BCMA target still cannot prevent the disease progress of a small numbers of patients. The control after CAR-T therapy needs more investigation.

|||||||||| dexamethasone / Generic mfg.
Dexamethasone Enhanced CAR T Cell Persistence and Function through Upregulation of Interleukin 7 Receptor (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3298;
We believe our observations could extend beyond hematological malignancies to a potentially potent and durable therapy for solid tumors, as Dex is not only an immunosuppressive agent but also an anti-cancer drug used against a multitude of tumors to prevent tumor growth as well as modulate the microenvironment. Our data also provided rationale on starting CAR T cell therapy without the necessity of tapering off the ongoing steroid treatment.

|||||||||| Ninlaro (ixazomib) / Takeda
Progression-Free Survival (PFS) According to the Presence of Adverse Cytogenetic Abnormalities in Patients (pts) with Multiple Myeloma (MM) Receiving Ixazomib (ixa)-Based vs Placebo (pbo)-Based Therapy: A Pooled Analysis of the TOURMALINE-MM1, MM2, MM3, and MM4 Phase 3 Studies (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3259;
However, due to the differences in study eligibility criteria and pt populations, ixa combined with Rd or as single-agent maintenance therapy may not abrogate the negative impact of high-risk CAs. Analyses of PFS in subgroups with specific CAs indicated that the greatest magnitudes of benefit (lowest HRs) with ixa-based vs pbo-based therapy were in pts with t(4;14) (HR 0.68) and pts with amp1q21 (HR 0.77), suggesting that the improved outcome with ixa-based vs pbo-based therapy in the expanded high-risk subgroup was primarily driven by PFS differences in pts with these more common CAs.

|||||||||| Darzalex IV (daratumumab) / J&J, Xpovio (selinexor) / Karyopharm
Selinexor in Combination with Daratumumab-Bortezomib and Dexamethasone for the Treatment of Relapse or Refractory Multiple Myeloma: Initial Results of the Phase 2, Open-Label, Multicenter GEM-Selibordara Study (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3258;
P2
96% and 71% of patients had MM refractory to lenalidomide (Len-Refr) and PI...Recommended supportive care to prevent Selinexor associated nausea (± anorexia) included ondansetron for 2 days and daily olanzapine... In this phase 2 single arm, open label study, the combination of Selinexor plus DVd showed encouraging efficacy and manageable safety profile both in the setting of late and particularly early relapse MM, although data in this second cohort is still immature and requires longer follow-up.

|||||||||| CFT7455 / C4 Therap
A Phase 1 Study of CFT7455, a Novel Degrader of IKZF1/3, in Multiple Myeloma and Non-Hodgkin Lymphoma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3256;
P1/2
Expansion cohorts of single-agent CFT7455 and CFT7455 plus dexamethasone in R/R MM, and single-agent CFT7455 for peripheral T-cell lymphoma and MCL are planned...Patients must not be candidates for regimens known to provide clinical benefit, defined as having received ≥3 prior anti-myeloma regimens including ≥2 consecutive cycles of lenalidomide, pomalidomide, a proteasome inhibitor, a glucocorticoid, and an anti-CD38 antibody...Approximately 164 patients at approximately 13 US sites will be enrolled. This trial is registered with clinicaltrials.gov as NCT04756726 , enrollment is ongoing.

|||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Isatuximab Rescue for Inadequate Response to Lenalidomide and Dexamethasone in Transplant Ineligible Patients with Newly Diagnosed Multiple Myeloma: Interim Analysis of the Phase II Iril Study of the Australian Myeloma Research Consortium (AMaRC 18-02) (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3252;
Isa-Rd leads to universal deepening of response in patients failing to achieve a PR or better after 4 months of Rd, while the overall response rate in evaluable patients, irrespective of initial response to Rd, is 100%. Isa-Rd is well tolerated in this elderly patient cohort.

|||||||||| Darzalex IV (daratumumab) / J&J, Blenrep (belantamab mafodotin) / GSK
Belantamab Mafadotin in Patients with Relapsed/Refractory AL Amyloidosis with Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_3251;
P2
One patient who had 24-hour urine protein evaluation also achieved a renal response. Time to response was rapid with 2 patients achieving HR within a week of starting treatment, and the rest within five months.



	Diseases Companies Products Productz Mechanisms of Action Sites