CD38-targeted antibody-drug conjugate News

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|||||||||| Venclexta (venetoclax) / Roche, AbbVie
Review, Journal: Updates in the Use of BCL-2-Family Small Molecule Inhibitors for the Treatment of Relapsed/Refractory Multiple Myeloma. (Pubmed Central) - Jul 29, 2022
Venetoclax, a Bcl-2-specific inhibitor, has generated the most clinical data and has shown promising results in patients with multiple myeloma harboring the t (11;14) translocation...Several other Bcl-2 inhibitors are in clinical development, as are inhibitors of Mcl-1, a Bcl-2-family oncoprotein that is perhaps more critical for myeloma cell survival than Bcl-2. This review will summarize the latest clinical data regarding the clinical development of Bcl-2-family protein inhibitors in the treatment of relapsed/refractory multiple myeloma.

|||||||||| Darzalex (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
Review, Journal: Targeting the Microenvironment for Treating Multiple Myeloma. (Pubmed Central) - Jul 29, 2022
Here, we describe the complex interplay between myeloma cells and the cellular components of the BMME that is essential for MM development and progression. Finally, we present BMME modifying treatment options such as anti-CD38 based therapies, immunomodulatory drugs (IMiDs), CAR T-cell therapies, bispecific antibodies, and antibody-drug conjugates which have significantly improved the long-term outcome of myeloma patients, and thus represent novel therapeutic standards.

|||||||||| Evaluation of gelatinase-responsive copolymeric nanoparticles targeting PD-1 and TGF-β pathways for treating immune-resistant tumor (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_2716;
Robust antitumor efficacy, long term memory and safety profile were demonstrated in vivo. Further, applying GPNPs aroused specific immunity and created an immune-permissive environment as shown by multi-modal single-cell analysis of TME.

|||||||||| Review, Journal: Central Nervous System Myeloma and Unusual Extramedullary Localizations: Real Life Practical Guidance. (Pubmed Central) - Jul 27, 2022
The role of novel agents in CNS MM management and unusual presentations will be discussed as well as the potential role of other new immunomodulatory drugs and proteasome inhibitors that seem to cross the blood-brain barrier. The purpose of this review is to increase awareness of the clinical unusual presentation and neuroradiological findings, give practical diagnostic advice and treatment options algorithm.

|||||||||| Additional Agents for RRMM - How Do/Will They Fit (Level 3, Room 336 AB) - Jul 26, 2022 - Abstract #SOHO2022SOHO_32;
There has been a plethora of new targets and agents that have been evaluated for relapsed/refractory multiple myeloma (RRMM) during this period, tested in the context of rigorous trials many of which have led to recent approvals.3-10 While some of the agents (panobinostat, melfl ufen) were not able to meet the regulatory hurdle for approval and were taken out of market due to their higher-than-expected toxicity or suboptimal effi cacy profi les, others that are currently available for treating myeloma patients both in and out of clinical trials have shown outstanding effi cacy...The upfront studies SWOG-S0777 [bortezomib, lenalidomide and dexamethasone (VRD) vs. lenalidomide and dexamethasone (Rd)]11, MAIA [daratumumab + Rd (D-Rd) vs. Rd]12, ALCYONE [daratumumab + bortezomib, melphalan and prednisone (D-VMP) vs. bortezomib, melphalan and prednisone (VMP)]13 not only demonstrated the feasibility, safety and effi cacy of combination induction regimens for transplant-ineligible patients, but have confi rmed that daratumumab-based upfront regimens could yield unprecedented results without compromising on safety...The addition of daratumumab to VRD in GRIFFIN trial19 and to bortezomib, thalidomide and dexamethasone (VTD) in CASSIOPEIA trial20 showed that increased depths of responses could be achieved as measured by sustained minimal residual disease (MRD) negativity 12 months, which translated to a progression free survival (PFS) benefi t, again making a strong case for the inclusion of CD38 mabs in the front-line setting...Not only that, the existing early relapse trials POLLUX (D-Rd vs. Rd)21, CASTOR [daratumumab, bortezomib and dexamethasone (D-Vd) vs bortezomib and dexamethasone (Vd)22, APOLLO [daratumumab, pomalidomide and dexamethasone (D-Pd) vs pomalidomide and dexamethasone (Pd)]23, ICARIA [isatuximab, pomalidomide and dexamethasone (I-Pd) vs Pd)]8, CANDOR [daratumumab, carfi lzomib and dexamethasone (D-Kd) vs carfi lzomib and dexamethasone (Kd)24, IKEMA [(Isatuximab, Kd (I-Kd) vs Kd]25 have strongly emphasized the clinical value of daratumumab in deeper responses and prolonging PFS the early relapse setting...The antibody drug conjugates (ADC) (belantamab)3, XP01 inhibitor (selinexor)4 as well as Chimeric Antigen Receptor (CAR) Therapies (ide-cel, ciltacel) 9,10 that were recently Food and Drug Administration (FDA) approved for patients with RRMM, and the ongoing trials with bispecifi c antibodies (BCMA/CD3, GPRC5D/CD3, FCRH5/ CD3 as targets) and other small molecules (such as BCL2 inhibitors, venetoclax in t(11;14) patients and CELMoDs) have clearly demonstrated early promising results as effective antimyeloma agents...BCMA targeting CAR-Ts, Ide-cel in the KarMMa-1 study (ORR 73%, mPFS 8.6 months)9 and Cilta-cel in the CARTITUDE-1 study (ORR 98%, mPFS not reached at 2 years),10 have gained FDA approvals in the recent years and are effective available options for selected fi t patients with good organ function that can withstand a cytokine release syndrome (CRS)...The newer CELMoD iberdomide binds cereblon and degrades Aiolos and Ikaros more effi ciently than the IMiDs (lenalidomide or pomalidomide)29. Clinically they have been evaluated as a single agent, with dexamethasone and in combinations with other anti-myeloma agents showing synergy and early promise.30,31 Venetoclax is an oral BCL2 inhibitor that has activity in t(11;14) or BCL2high patients.32 The off-the shelf readily available agents such as belantamab, the bispecifi c antibodies, and other small molecules bring hope and promise to RRMM patients.

|||||||||| Carvykti (ciltacabtagene autoleucel) / J&J
Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to BCMA-targeting antibody-drug conjugate treatment (Petree Hall C) - Jul 21, 2022 - Abstract #IMW2022IMW_182;
P2
MM patients who had previous exposure to an anti-BCMA ADC therapy had favorable responses, DOR, and PFS following cilta-cel. These results may inform treatment plans, including sequencing and washout period between BCMA-targeting agents.

|||||||||| Darzalex (daratumumab) / J&J, Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Blenrep (belantamab mafodotin) / GSK
Salvage Therapies and Clinical Outcomes After Relapse Following BCMA CAR-T in Patients with Relapsed/Refractory Multiple Myeloma (West Hall B) - Jul 21, 2022 - Abstract #IMW2022IMW_131;
Subsequent BCMA-directed immunotherapies may be effective in these patients. Other conventional treatments may also elicit clinical responses, but durations of responses appear limited.

|||||||||| Blenrep (belantamab mafodotin) / GSK
An interim analysis of a phase I/II single arm study of belantamab mafodotin, carfilzomib and dexamethasone in patients with relapsed multiple myeloma: AMaRC 19-02 BelaCarD study (West Hall B) - Jul 21, 2022 - Abstract #IMW2022IMW_130;
Deep responses were seen. Recruitment is ongoing in an expansion phase based on the preliminary safety and efficacy.

|||||||||| Darzalex (daratumumab) / J&J
Journal: Daratumumab combined with dexamethasone and lenalidomide or bortezomib in relapsed/refractory multiple myeloma (RRMM) patients: Report from the multiple myeloma GIMEMA Lazio group. (Pubmed Central) - Jul 20, 2022
The most common nonhematologic TAEs were peripheral sensory neuropathy and infections. Our data confirmed that DRd or DVd therapy is effective and safe in RRMM pts, and our real-life analysis could support the physicians regarding the choice of optimal therapy in this setting of pts.

|||||||||| Venclexta (venetoclax) / Roche, AbbVie
Review, Journal: How I treat triple-class refractory multiple myeloma. (Pubmed Central) - Jul 20, 2022
The main open questions in TCR MM are preferred sequence of existing therapies, the utility of sequential use of agents with similar mechanism of action, but different immunotherapy target and the relative efficacy of the different anti-BCMA platforms. Here, we summarise the existing literature and provide general guidance on selecting therapy for this challenging and heterogenous group of patients.

|||||||||| Journal: New and emerging pharmacotherapies for management of multiple myeloma. (Pubmed Central) - Jul 13, 2022
Several therapeutic agents have been recently approved by the Food and Drug Administration for the treatment of multiple myeloma. There are many novel agents in the pipeline, including bispecific antibodies and CAR T-cell therapies that have the potential to continue to change the treatment landscape of multiple myeloma.

|||||||||| ISB 1442 / Glenmark
ISB 1442, a first-in-class CD38 and CD47 bispecific antibody innate cell modulator for the treatment of CD38 positive hematological malignancies () - Jul 8, 2022 - Abstract #ITOC2022ITOC_62;
Conclusions We report a novel approach for the treatment for CD38 positive hematologic malignancies by co-targeting CD38 and CD47 using a first in class multispecific antibody. Based on its unique design and multiple mechanisms of action, ISB 1442 is anticipated to enhance antitumor activity in patients relative to anti-CD38 mAbs by overcoming primary and acquired tumor escape mechanisms of resistance.

|||||||||| Darzalex (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
Biomarker, Journal, Next-generation sequencing, IO biomarker: Identification of New Antibodies Targeting Malignant Plasma Cells for Immunotherapy by Next-Generation Sequencing-Assisted Phage Display. (Pubmed Central) - Jul 6, 2022
Further analyses revealed that #5-CD38-IgG1 shared an overlapping epitope with daratumumab and isatuximab and had potent anti-myeloma activity comparable to the two clinically approved CD38 antibodies. These results indicate that by phage display and deep sequencing, new antibodies with therapeutic potential for MM immunotherapy can be identified.

||||||||||  STI-6129 / Sorrento
Trial initiation date:  Study to Assess Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) -  Jun 30, 2022
P1b/2a, N=72, Recruiting,  Sponsor: Sorrento Therapeutics, Inc.
These results indicate that by phage display and deep sequencing, new antibodies with therapeutic potential for MM immunotherapy can be identified. Initiation date: May 2022 --> Sep 2022

|||||||||| Multimodal Analysis of DNA and Proteins in Single Cells (Poster Area) - Jun 28, 2022 - Abstract #EACR2022EACR_456;
Conclusion This is the first method to effectively link surface and intracellular protein measurement with targeted DNA analysis. This approach enables the correlation of genotypic and phenotypic readouts from single cells, allowing for concurrent multimodal analysis of cancer evolution and the protein expression that drives it.

|||||||||| Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
Neoadjuvant DS-8201 for Stage III Non-small Cell Lung Cancer with HER2 20ins (Exhibit Hall - Hall B) - Jun 24, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_1178;
DS-8201 could produce effect regardless of HER-2 protein expression. This case has provided an insight into the potential usage of ADC in a neoadjuvant setting.

|||||||||| Review, Journal: Treatment Options for Patients With Heavily Pretreated Relapsed and Refractory Multiple Myeloma. (Pubmed Central) - Jun 22, 2022
Data from recent clinical trials of immunomodulatory agents (pomalidomide), proteasome inhibitors (PIs; carfilzomib and ixazomib), monoclonal antibodies (elotuzumab, daratumumab, and isatuximab), and other novel therapies (including panobinostat-based therapy) are summarized...Regimens containing pomalidomide, elotuzumab, next-generation PIs, panobinostat, or selinexor may provide effective treatment options in patients with triple-refractory disease. The choice of agents used, and combinations thereof should be individualized as well as strategically planned from early- to late-stage relapse.

|||||||||| Darzalex (daratumumab) / J&J, Sarclisa (isatuximab-irfc) / Sanofi
Journal: Pharmacy considerations: Use of anti-CD38 monoclonal antibodies in relapsed and/or refractory multiple myeloma. (Pubmed Central) - Jun 22, 2022
The choice of agents used, and combinations thereof should be individualized as well as strategically planned from early- to late-stage relapse. Given that pharmacists play an integral role in driving cost-effective use of drugs without compromising efficacy and safety for the end user, educating pharmacists on the key differences between isatuximab and daratumumab can guide the selection of the appropriate anti-CD38 antibody.

|||||||||| Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Review, Journal: Daratumumab: A review of current indications and future directions. (Pubmed Central) - Jun 4, 2022
With such success within MM, daratumumab is now being explored in other disease states. This article will review daratumumab's drug development, practical use, and future potential indications.

|||||||||| Darzalex (daratumumab) / J&J
Clinical, Journal: How I Treat Frontline Transplant-eligible Multiple Myeloma. (Pubmed Central) - May 19, 2022
High-dose melphalan supported by autologous transplantation has been the standard of care for eligible patients with newly diagnosed multiple myeloma (MM) for >25 years...Immunotherapy is currently changing the paradigm of MM management, and daratumumab is the first-in-class human monoclonal antibody targeting CD38 approved in the setting of newly diagnosed MM...Otherwise, the development of sensitive and specific tools for disease prognostication allows to consider adaptive strategy to a dynamic risk. I discuss in this review the different available options for the treatment of transplant-eligible multiple myeloma patients in frontline setting.

|||||||||| Review, Journal: The Leading Role of the Immune Microenvironment in Multiple Myeloma: A New Target with a Great Prognostic and Clinical Value. (Pubmed Central) - May 15, 2022
New experimental drugs currently being evaluated (CD137 blockers, MSC-derived microvesicle blockers, CSF-1/CSF-1R system blockers, and Th17/IL-17/IL-17R blockers) or already approved (denosumab and bisphosphonates) may help slow down immune escape and disease progression. Thus, the identification of deregulated mechanisms may identify novel immunotherapeutic approaches to improve MM patients' outcomes.

|||||||||| Abecma (idecabtagene vicleucel) / BMS, 2seventy bio, Blenrep (belantamab mafodotin) / GSK
HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) TREATED WITH IDECABTAGENE VICLEUCEL VS BELANTAMAB MAFODOTIN: A MATCHING-ADJUSTED INDIRECT COMPARISON STUDY () - May 13, 2022 - Abstract #EHA2022EHA_2318;
P2
Sensitivity analyses were consistent with the base case analyses. Conclusion While this analysis was limited by the availability of aggregate data from DREAMM-2, which may influence the outcomes of interest, results suggest that one-time treatment with ide-cel offers improved HRQoL vs BM across the QLQ-C30 pain, fatigue, and global health status/QoL domains, as well as the QLQ-MY20 pain domain.

|||||||||| elranatamab (PF-06863135) / Pfizer
A PHASE 2 TRIAL OF ELRANATAMAB, A B-CELL MATURATION ANTIGEN (BCMA)-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: INITIAL SAFETY RESULTS FOR MAGNETISMM-3 () - May 13, 2022 - Abstract #EHA2022EHA_2069;
P2
Data will be updated at the time of presentation to include ~90 patients. Conclusion Preliminary results of MagnetisMM-3 in patients with R/R MM and no prior BCMA-targeted treatment suggest that 76 mg QW elranatamab with a 2-step-up priming regimen is well tolerated, with no G ≥3 CRS or ICANS observed.

|||||||||| Blenrep (belantamab mafodotin) / GSK
A PHASE I/II SINGLE ARM STUDY OF BELANTAMAB MAFODOTIN, CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA: AMARC 19-02 BELACARD STUDY. () - May 13, 2022 - Abstract #EHA2022EHA_2068;
Deep responses were seen. Recruitment is ongoing in an expansion phase based on the preliminary safety and efficacy.

|||||||||| WVT078 / Novartis
PRECLINICAL DISCOVERY AND EARLY FINDINGS FROM THE PHASE 1, DOSE-ESCALATION STUDY OF WVT078, A BCMA-CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH R/R MULTIPLE MYELOMA () - May 13, 2022 - Abstract #EHA2022EHA_2031;
P1
In the phase 1 study, WVT078 exhibited an acceptable safety profile and preliminary evidence of clinical activity. Clinical evaluation of WVT078 as a single agent and in combination with a gamma secretase inhibitor is ongoing.

|||||||||| Blenrep (belantamab mafodotin) / GSK
HIGH RESPONSES RATES WITH SINGLE AGENT BELANTAMAB MAFODOTIN IN RELAPSED SYSTEMIC AL AMYLOIDOSIS () - May 13, 2022 - Abstract #EHA2022EHA_2026;
P2
Two patients with renal impairment (stage V CKD and ESRD) and one patient post-renal transplant tolerated treatment with no additional toxicity. Belantamab mafodotin shows promise in treatment of relapsed AL and needs further prospective trials.

|||||||||| elranatamab (PF-06863135) / Pfizer
MAGNETISMM-9: AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 1/2 STUDY OF ELRANATAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA () - May 13, 2022 - Abstract #EHA2022EHA_1996;
P2
ClinicalTrials.gov ID: NCT05014412. Results Results not available (trial-in-progress) Conclusion Conclusion not available (trial-in-progress)

|||||||||| ISB 1442 / Glenmark
ISB 1442, A FIRST-IN-CLASS CD38 AND CD47 BISPECIFIC ANTIBODY INNATE CELL MODULATOR FOR THE TREATMENT OF CD38 POSITIVE HEMATOLOGICAL MALIGNANCIES () - May 13, 2022 - Abstract #EHA2022EHA_1951;
Conclusion In summary, we report a novel approach for the treatment for CD38 positive hematologic malignancies by co-targeting CD38 and CD47 using a first in class multispecific antibody. Based on its unique design and multiple mechanisms of action, ISB 1442 is anticipated to enhance antitumor activity in patients relative to anti-CD38 mAbs by overcoming primary and acquired tumor escape mechanisms of resistance.

|||||||||| Darzalex (daratumumab) / J&J, CYT-338 / Cytovia Therap, theralizumab (TAB08) / TheraMab
NOVEL MULTIFUNCTIONAL TETRAVALENT CD38 NKP46 FLEX-NK ENGAGERS ACTIVELY TARGET AND KILL MULTIPLE MYELOMA CELLS () - May 13, 2022 - Abstract #EHA2022EHA_1925;
Cytokine release assessment of CYT-338 in the human PBMC assay showed no evidence of cytokine release while high levels of cytokine release was observed with daratumumab, anti-CD28 (TGN1412) and CD3 antibody controls. Conclusion These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38 expressing multiple myeloma distinct from daratumumab.

|||||||||| teclistamab (JNJ-64007957) / Genmab, J&J
EVALUATING TECLISTAMAB IN PATIENTS WITH RELAPSED/ REFRACTORY MULTIPLE MYELOMA FOLLOWING EXPOSURE TO OTHER B-CELL MATURATION ANTIGEN (BCMA)-TARGETED AGENTS (Hall A8) - May 13, 2022 - Abstract #EHA2022EHA_1897;
Conclusion These preliminary results observed with serial targeting of BCMA with teclistamab following ADC or CAR‑T tx suggest a promising ORR with early responses that deepen over time. Additionally, a well-tolerated safety profile was observed in patients treated with anti-BCMA tx.

|||||||||| Keytruda (pembrolizumab) / Merck (MSD), Blenrep (belantamab mafodotin) / GSK
SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN WITH PEMBROLIZUMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): DREAMM-4 STUDY () - May 13, 2022 - Abstract #EHA2022EHA_1878;
P1/2
No new TRAEs were identified; AE frequency and severity were similar to single-agent belamaf. Correlative biomarker studies are ongoing.

|||||||||| Darzalex (daratumumab) / J&J
DARATUMUMAB (D) IN COMBINATION WITH VD OR D-RD IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA: SUBGROUP ANALYSIS OF CASTOR AND POLLUX STUDIES IN PATIENTS WITH EARLY OR LATE RELAPSE AFTER INITIAL THERAPY () - May 13, 2022 - Abstract #EHA2022EHA_1876;
Conclusion These post hoc analyses of CASTOR and POLLUX showed PFS and depth of response benefits of DARA-containing regimens in patients with 1 prior line of therapy, regardless of relapse timing (early or late). Our results support the use of D-Vd and D-Rd in RRMM, including in patients who are considered functional high risk.

|||||||||| teclistamab (JNJ-64007957) / Genmab, J&J
UPDATED EFFICACY AND SAFETY RESULTS OF TECLISTAMAB, A B-CELL MATURATION ANTIGEN X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA FROM MAJESTEC-1 () - May 13, 2022 - Abstract #EHA2022EHA_1866;
P1
No new safety signals were identified. Additional data with longer follow-up, including subgroup analyses and progression-free survival, will be presented.

|||||||||| Darzalex (daratumumab) / J&J
EFFICACY AND SAFETY OF DARATUMUMAB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA OR LYMPHOBLASTIC LYMPHOMA: RESULTS FROM PHASE 2 DELPHINUS STUDY () - May 13, 2022 - Abstract #EHA2022EHA_1833;
In a phase 2 study, 2 of 7 (28.6%) patients with T-cell ALL in first relapse achieved a complete response (CR) using the vincristine, prednisone, PEG-asparaginase, and doxorubicin (VPLD) reinduction backbone...DARA (16 mg/kg IV QW) was given with VPLD in Cycle 1 and with methotrexate, cyclophosphamide, cytarabine, and 6-mercaptopurine in Cycle 2...No pediatric ALL pt discontinued DARA primarily due to AEs and 1 (4.2%) died due to TEAEs (brain edema and hepatic failure) attributed to study treatment but unrelated to DARA. Conclusion The addition of DARA to VPLD in pediatric and young adult patients with relapsed/refractory T-cell ALL or LL showed initial activity, generating improved response rates compared to those achieved with backbone therapy alone, with a manageable safety profile.

|||||||||| cevostamab (RG6160) / Roche
CAMMA 3: A MULTICENTER PHASE IB TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF SUBCUTANEOUS CEVOSTAMAB MONOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA () - May 13, 2022 - Abstract #EHA2022EHA_1832;
Conclusion CAMMA 3 is a study of SC cevostamab monotherapy in patients with R/R MM. Further study details will be presented.

|||||||||| cevostamab (RG6160) / Roche
CAMMA 1: A MULTICENTER PHASE IB TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS AND ACTIVITY OF CEVOSTAMAB-CONTAINING REGIMENS IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA () - May 13, 2022 - Abstract #EHA2022EHA_1831;
P1
Aims To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of cevostamab-containing combination regimens (Arm B: cevostamab plus P and dexamethasone [d] [Pd]; Arm C: cevostamab plus Dd) in patients with R/R MM...Conclusion CAMMA 1 is an ongoing study of cevostamab plus Pd, cevostamab plus Dd and cevostamab monotherapy in patients with R/R MM. Further study details will be presented.

|||||||||| Blenrep (belantamab mafodotin) / GSK
EXPLORING ALTERNATIVE DOSING REGIMENS OF SINGLE-AGENT BELANTAMAB MAFODOTIN ON SAFETY AND EFFICACY IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA: DREAMM-14 () - May 13, 2022 - Abstract #EHA2022EHA_1830;
P2
Follow-up for progression-free survival will be Q3W until progressive disease, start of new anticancer therapy, withdrawal of consent, end of study, or death. Results N/A Conclusion First patient first visit is currently targeted for 04Mar22.

|||||||||| QUANTITATIVE EXPRESSION PROFILING OF SURFACE ANTIGENS ON PERIPHERAL BLOOD LEUKOCYTE SUBSETS AND CHILDHOOD T-ALL CELLS USING A STANDARDIZED FLOW CYTOMETRY WORKFLOW: A HCDM CDMAPS INITIATIVE () - May 13, 2022 - Abstract #EHA2022EHA_582;
Conclusion In summary, we optimized a procedure for quantitative expression profiling of surface antigens on subsets of blood leukocyte and proved its feasibility with inter-laboratory comparison in three different laboratories. The presented workflow enables (i) to map the expression patterns of HLDA-approved antibody clones to CD markers, (ii) to benchmark new antibody clones to established CD markers, (iii) to define new clusters of differentiation in future HLDA workshops and (iv) mapping of childhood T-ALL cells.

|||||||||| ISB 1442 / Glenmark
ISB 1442, a first-in-class CD38 and CD47 bispecific antibody innate cell modulator for the treatment of CD38 positive hematologic malignancies. () - May 9, 2022 - Abstract #CIMT2022CIMT_164;
In summary, we report a novel approach for the treatment of CD38 positive hematologic malignancies by co-targeting CD38 and CD47with a single agent. Based on its unique design and multiple mechanisms of action, ISB 1442 is anticipated to enhance antitumor activity in patients relative to anti-CD38 mAbs by overcoming primary and acquired tumor escape mechanisms of resistance.

|||||||||| Darzalex (daratumumab) / J&J, ISB 1342 / Glenmark, magrolimab (GS-4721) / Ono Pharma, Gilead
A multispecific antibody platform for optimal engineering of multiple myelomaimmunotherapies. () - May 9, 2022 - Abstract #CIMT2022CIMT_156;
P1
In summary, we report two novel approaches for the treatment of MM using the BEAT technology to co-target either CD38 and CD3, or CD38 and CD47. The designs of ISB 1342 and ISB 1442 are anticipated to enhance antitumor activity in MM patients by overcoming primary and acquired mechanisms of resistance.

|||||||||| Review, Journal: BCMA-Targeted Biologic Therapies: The Next Standard of Care in Multiple Myeloma Therapy. (Pubmed Central) - May 6, 2022
Still, many questions remain with regard to this target, including how best to target it, how to treat patients who have progressed on a BCMA-targeting therapy, and whether response rates will deepen if these agents are used in earlier lines of therapy. In this review, we examine the rationale for targeting BCMA and summarize the data for several agents across multiple classes of BCMA-targeting therapeutics, paying special attention to the diverse mechanisms and unique challenges of each therapeutic class.

|||||||||| iPSC-Derived CD38-Null NK Cells in Combination with CD38-Targeted Antibody Represent a Novel Therapeutic Strategy to Avoid Host Immune Cell Rejection for Off-the-Shelf Cell-Based Cancer Immunotherapy (Poster Board Number: Tu-173; Hall D) - May 6, 2022 - Abstract #ASGCT2022ASGCT_1489;
Ongoing in vivo studies suggest that co-administration of anti-CD38 antibodies can significantly enhance the persistence of iNK cells in the presence of allogeneic PBMCs as seen in the blood, spleen and bone marrow. These data demonstrate the potential advantages of combining iPSC-derived CD38-null NK cells with anti-CD38 antibodies as a novel therapeutic strategy for reducing conditioning chemotherapy, depleting alloreactive lymphocytes, and promoting off-the-shelf cell therapy.

|||||||||| montelukast / Generic mfg., aspirin / Generic mfg.
Successful Desensitization to Daratumumab: a Case Report and Review of the Literature () - Apr 30, 2022 - Abstract #EAACI2022EAACI_1365;
This represents a challenge for allergists requiring constant scientific update and shared clinical experience. It is important to move on to better and faster desensitization protocols, as the patient might need the treatment for a long period of time.

|||||||||| Observational data, Journal: Low clinical protective response to SARS-CoV-2 mRNA COVID-19 vaccine in patients with multiple myeloma. (Pubmed Central) - Apr 30, 2022
Patients with clinically protective titer had a significantly higher number of CD19+ lymphocytes than those with lower antibody responses (114 vs. 35/μL, p = 0.016). Our results suggested that patients with PCD should be vaccinated, and that the ideal protocol is to temporarily interrupt anti-CD38 antibody therapy for a "wash-out" period of a few months, followed by a (booster) vaccine after the B-cells have recovery.

|||||||||| Darzalex Faspro (daratumumab/hyaluronidase) / J&J
Subcutaneous daratumumab (DARA SC) versus active monitoring in patients (pts) with high-risk smoldering multiple myeloma (SMM): Randomized, open-label, phase 3 AQUILA study. (Available On Demand; 494b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4187;
P3
The study completed enrollment on May 6, 2019; 390 pts have been randomly assigned to DARA SC or active monitoring. The primary efficacy analysis will be performed after approximately 165 PFS events have been observed.

|||||||||| elranatamab (PF-06863135) / Pfizer, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
MagnetisMM-5: An open-label, multicenter, randomized phase 3 study of elranatamab as monotherapy and in combination with daratumumab in patients with relapsed/refractory multiple myeloma. (Available On Demand; 494a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4186;
P3
MagnetisMM-5 is an open-label, multicenter, randomized phase 3 study designed to evaluate the efficacy and safety of subcutaneous (SC) elranatamab monotherapy and SC elranatamab + SC daratumumab in pts with relapsed/refractory MM who have received prior therapy, including lenalidomide and a proteasome inhibitor (PI)...In part 2, ̃450 pts will be stratified by prior lines of therapy (1 vs 2–3 vs ≥4) and prior treatment with anti-CD38 therapy (yes vs no) and enrolled in a 1:1:1 ratio to receive SC elranatamab or SC elranatamab + SC daratumumab or SC daratumumab + oral pomalidomide + oral dexamethasone...Key exclusion criteria include smoldering MM, plasma cell leukemia, amyloidosis, POEMS syndrome, stem cell transplant within 12 wk of enrollment, primary refractory MM, active, uncontrolled bacterial, fungal, or viral infections, previous treatment with BCMA-targeted therapy, anti-CD38 therapy within 6 mo of the first dose of study treatment, and previous pomalidomide therapy. MagnestisMM-5 will include sites in 28 countries.

|||||||||| Blenrep (belantamab mafodotin) / GSK
Exploring alternative dosing regimens of single-agent belantamab mafodotin on safety and efficacy in patients with relapsed or refractory multiple myeloma: DREAMM-14. (Available On Demand; 493b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4185;
P2
Status: Recruitment is ongoing. Funding: GSK (Study 209628); drug linker technology licensed from Seagen Inc.; mAb produced using POTELLIGENT Technology licensed from BioWa.

|||||||||| cevostamab (RG6160) / Roche
CAMMA 3: A multicenter phase Ib trial evaluating the safety, pharmacokinetics, and activity of subcutaneous cevostamab monotherapy in patients with relapsed or refractory multiple myeloma. (Available On Demand; 492a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4182;
Primary objectives are to evaluate the safety and tolerability (including the maximum tolerated dose and dose-limiting toxicities) of SC cevostamab and to identify a recommended Phase II dose. Secondary objectives include assessment of PK, activity, and immunogenicity, and identification of biomarkers associated with response and resistance.

|||||||||| cevostamab (RG6160) / Roche
CAMMA 1: A multicenter phase Ib trial evaluating the safety, pharmacokinetics, and activity of cevostamab-containing regimens in patients with relapsed or refractory multiple myeloma. (Available On Demand; 491b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4181;
P1
CAMMA 1 (NCT04910568) is an open-label, multicenter Phase Ib trial evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of cevostamab-containing combination regimens (Arm B: cevostamab plus P and dexamethasone [d] [Pd]; Arm C: cevostamab plus Dd) in patients with R/R MM...The primary objective is to evaluate the safety and tolerability of cevostamab plus Pd, cevostamab plus Dd and cevostamab monotherapy. Secondary objectives include assessment of activity, PK, immunogenicity, and pharmacodynamic biomarkers.

|||||||||| elranatamab (PF-06863135) / Pfizer
MagnetisMM-9: An open-label, multicenter, non-randomized phase 1/2 study of elranatamab in patients with relapsed/refractory multiple myeloma. (Available On Demand; 491a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4180;
P2
Key exclusion criteria are smoldering MM, active plasma cell leukemia, amyloidosis, POEMS syndrome, stem cell transplant within 12 weeks of enrollment, active, uncontrolled bacterial, fungal, or viral infections, or any other active malignancy within 3 years prior to enrollment (except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ), or previous treatment with an anti-BCMA bispecific antibody. The study is open at centers in the USA, UK, Japan, and Taiwan.



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