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23 Diseases |  |
162 Trials |
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- | Journal: Epidermal necrolysis in the context of immuno-oncologic medication as well as kinase inhibitors and biologics. (Pubmed Central) - Jun 22, 2022
Fourteen cases were EN-like reactions: six bullous lichenoid drug eruptions (DE) to pembrolizumab (2), obinutuzumab, nivolumab, rituximab, infliximab/nivolumab, and eight multiforme-like DE to rituximab (2), adalimumab, ramucirumab, bevacizumab, vemurafenib, sorafenib (2)...A correct diagnosis is highly relevant in terms of prognosis and use of these drugs in malignoma treatment. Re-exposure is contraindicated in EN, but possible in other DE after rigorous risk-benefit evaluation.
- | Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial suspension: A041702: Testing The Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Jun 16, 2022
P3, N=454, Suspended, Sponsor: National Cancer Institute (NCI)
Re-exposure is contraindicated in EN, but possible in other DE after rigorous risk-benefit evaluation. Recruiting --> Suspended
- ||| bortezomib / Generic mfg., carfilzomib / Generic mfg., Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
FDA event: What about when the “inferior control arm” is the one acceptable to the fda: ie obinutuzumab/clb or bortezomib / carfilzomib on approved schedule that nobody uses anymore. What about when standards change over the course of the study. (Twitter) - Jun 15, 2022
- | Comirnaty (tozinameran) / Pfizer, Fosun Pharma, BioNTech, Spikevax (elasomeran) / Moderna, Takeda
Observational data, Journal: Humoral response and safety of the BNT162b2 and mRNA-1273 COVID-19 vaccines in patients with haematological diseases treated with anti-CD20 antibodies: An observational study. (Pubmed Central) - Jun 15, 2022
Recruiting --> Suspended No abstract available
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal, Heterogeneity: Clonal heterogeneity of polymorphic B-cell lymphoproliferative disease, EBV-positive, iatrogenic/immune senescence: implications on pathogenesis and treatment. (Pubmed Central) - Jun 14, 2022
Treatment with O-CHOP (obinutuzumab, cyclophosphamide, adriamycin, vincristine, prednisolone) led to undetectable plasma EBV DNA, suggesting eradiation of the EBV-positive malignant clone...On treatment with lenalidomide, she finally achieved complete metabolic response...However, the EBV- plasma cell lesion showed mutations in five genes (TP53, SF3B1, STAT5B, CD79B and CRKL), suggesting that these mutations instead of EBV infection were the oncogenic driver. The presence of both EBV+ and EBV- lesions, which showed different mutational profiles, indicated clonal heterogeneity that might be of biologic and therapeutic significance.
- || Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Gallium trial: Minimal or no role for obinutuzumab in FL , although PFS and TTNT benefit , absence of OS benefit in long follow up. PFS is not a surrogate end point in FL. #EHA2022 (Twitter) - Jun 11, 2022
- | Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion, Combination therapy: SAKK 35/15: Obinutuzumab in Combination With Venetoclax in Previously Untreated Follicular Lymphoma Patients (clinicaltrials.gov) - Jun 10, 2022
P1, N=25, Completed, Sponsor: Swiss Group for Clinical Cancer Research
The presence of both EBV+ and EBV- lesions, which showed different mutational profiles, indicated clonal heterogeneity that might be of biologic and therapeutic significance. Active, not recruiting --> Completed
- || Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche, Biogen
Trial initiation date, Trial primary completion date, Combination therapy: CO43805: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Jun 9, 2022
P1, N=112, Not yet recruiting, Sponsor: Hoffmann-La Roche
Active, not recruiting --> Completed Initiation date: Apr 2022 --> Aug 2022 | Trial primary completion date: Dec 2024 --> Apr 2025
- ||||| Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Clinical, Monotherapy: Treatment with zanubrutinib and obinutuzumab improved outcomes in patients with relapsed/refractory follicular lymphoma vs obinutuzumab monotherapy. #lymsm #ASCO22 |@ASCO @JuanAlderuccio https://t.co/fFdiLMKQ9w (Twitter) - Jun 9, 2022
- || Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial primary completion date: Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL (clinicaltrials.gov) - Jun 8, 2022
P2, N=72, Recruiting, Sponsor: Dana-Farber Cancer Institute
Initiation date: Apr 2022 --> Aug 2022 | Trial primary completion date: Dec 2024 --> Apr 2025 Trial primary completion date: Jul 2022 --> Jan 2024
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Coadministration with bendamustine restores the antitumor activity of obinutuzumab in obinutuzumab-resistant tumors. (Pubmed Central) - Jun 8, 2022
Trial primary completion date: Jul 2022 --> Jan 2024 Coadministration of bendamustine in obinutuzumab retreatment may be effective against obinutuzumab-resistant tumors.
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Retrospective data, Journal: Higher incidence of thrombocytopenia during obinutuzumab plus bendamustine therapy for untreated follicular lymphoma: a retrospective analysis by the Okayama Hematology Study Group. (Pubmed Central) - Jun 8, 2022
Notably, although eight of nine patients with grade 3-4 thrombocytopenia were female, no patient characteristics (including gender) were significantly associated with grade 3-4 thrombocytopenia. Importantly, grade 3-4 thrombocytopenia frequently occurred in the first GB therapy cycle, which suggests that platelet count should be monitored carefully in patients who have just started GB therapy.
- | Journal: Immunotherapy in indolent Non-Hodgkin's Lymphoma. (Pubmed Central) - Jun 8, 2022
Other agents include MAB targeting T-Cells like mogamulizumab, Denileukin Diftitox and BiTEs or bispecific T cell engagers like Mosunetuzumab, Glofitamab, and Epcoritamab...Another important aspect in immunotherapy is the half-lives of the medication which is an important factor that can influence the evaluation of the response. The MAB treatment showed important benefit in the treatment of iNHL and it continuously shows how rapidly it can develop to provide optimum care and benefit to patients with iNHL.
- | Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Trial suspension: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov) - Jun 8, 2022
P1, N=12, Suspended, Sponsor: National Cancer Institute (NCI)
The MAB treatment showed important benefit in the treatment of iNHL and it continuously shows how rapidly it can develop to provide optimum care and benefit to patients with iNHL. Recruiting --> Suspended
- |||| Venclexta (venetoclax) / Roche, AbbVie, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
@DrAnitaKumar doing a great job presenting the BOVEN study during the MCL education session #ASCO22 (Zanubrutinib, obinutuzumab, venetoclax) in an MRD driven design in TP53 mutated mantle cell lymphoma #lymSM (Twitter) - Jun 6, 2022
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial termination: GIOTTO: Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients (clinicaltrials.gov) - Jun 6, 2022
P2, N=29, Terminated, Sponsor: Fondazione Italiana Linfomi ONLUS
However, the enrolled patients concluded therapy and continued into the follow-up phase. The study was closed only after LVLP.
- ||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Clinical, P3 data, Journal, IO biomarker: Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features: integrated analysis of two phase 3 studies. (Pubmed Central) - Jun 4, 2022
P3
Ibrutinib-based therapy improved overall response rates (ORRs), complete response rates, and progression-free survival (PFS) versus chlorambucil-based therapy across all subgroups...This integrated analysis demonstrated efficacy of first-line ibrutinib-based treatment irrespective of cytogenetic and mutational risk features. Registered at ClinicalTrials.gov (NCT01722487 and NCT02264574).
- | Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Enrollment closed: Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - Jun 1, 2022
P2, N=23, Active, not recruiting, Sponsor: Emory University
Registered at ClinicalTrials.gov (NCT01722487 and NCT02264574). Recruiting --> Active, not recruiting
- | Anyara (naptumomab estafenatox) / NeoTX
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Naptumomab Estafenatox in Combination With Durvalumab in Subjects With Selected Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - Jun 1, 2022
P1b, N=50, Recruiting, Sponsor: NeoTX Therapeutics Ltd.
Recruiting --> Active, not recruiting Trial completion date: Jul 2022 --> Mar 2023 | Trial primary completion date: Apr 2022 --> Dec 2022
- ||| MS-553 / MingSight Pharma
Enrollment change: A Study Of The Selective PKC-? Inhibitor MS- 553 (clinicaltrials.gov) - May 31, 2022
P1/2, N=117, Recruiting, Sponsor: MingSight Pharmaceuticals, Inc
Trial completion date: Jul 2022 --> Mar 2023 | Trial primary completion date: Apr 2022 --> Dec 2022 N=47 --> 117
- || Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Lupus Nephritis: Improving Treatment Options. (Pubmed Central) - May 31, 2022
In the present article, we summarize the existing lupus nephritis management recommendations, followed by a critical appraisal of the randomized trials of belimumab and voclosporin, as well as the available data on obinutuzumab and other novel compounds under development. We conclude that pending the identification of accurate clinical, histological, or translational predictors for guiding personalized decisions, it is of utmost importance that lupus nephritis patients are monitored closely with appropriate treatment adjustments aiming at a prompt, deep response to ensure long-term preservation of kidney function.
- ||| iberdomide (CC-220) / BMS
Enrollment change, Trial primary completion date, Combination therapy: A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas (clinicaltrials.gov) - May 31, 2022
P1/2, N=232, Recruiting, Sponsor: Celgene
We conclude that pending the identification of accurate clinical, histological, or translational predictors for guiding personalized decisions, it is of utmost importance that lupus nephritis patients are monitored closely with appropriate treatment adjustments aiming at a prompt, deep response to ensure long-term preservation of kidney function. N=152 --> 232 | Trial primary completion date: Jan 2022 --> Aug 2023
- | glofitamab (RG6026) / Roche
Journal, CAR T-Cell Therapy: Glofitamab Treatment in Relapsed or Refractory DLBCL after CAR T-Cell Therapy. (Pubmed Central) - May 30, 2022
Interestingly, we identified increased persistence of circulating CAR T-cells in peripheral blood in three of the five patients with measurable CAR T-cells. Our data suggest that glofitamab treatment is well tolerated and effective in patients with DLBCL relapsing after CAR T-cell therapy and can enhance residual CAR T-cell activity.
- || Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Tecentriq (atezolizumab) / Roche
P2 data, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: A phase-II study of atezolizumab in combination with obinutuzumab or rituximab for relapsed or refractory mantle cell or marginal zone lymphoma or Waldenström's macroglobulinemia. (Pubmed Central) - May 29, 2022
P2
One fatal TEAE (pneumonia) occurred in each of the MCL and MZL groups. Biomarker analysis highlighted the importance of characterizing the immune environment to optimize efficacy of immunotherapy regimens.Trial registration details: EudraCT: 2016-003579-22.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
TIME-LIMITED VENETOCLAX-OBINUTUZUMAB +/- IBRUTINIB IS SUPERIOR TO CHEMOIMMUNOTHERAPY IN FRONTLINE CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): PFS CO-PRIMARY ENDPOINT OF THE RANDOMIZED PHASE 3 GAIA/CLL13 TRIAL (Hall A2-A3) - May 28, 2022 - Abstract #EHA2022EHA_2901;
Fatal AEs occurred in 9 pts with GV and GIV each, 10 with CIT and 8 with RV. Conclusion Time-limited treatment with GIV or GV improves PFS compared to standard CIT in fit, previously untreated patients with CLL.
- || Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Clinical, Journal: Evaluation and associated risk factors for neutropenia with venetoclax and obinutuzumab in the treatment of chronic lymphocytic leukemia. (Pubmed Central) - May 26, 2022
This could be attributed to a higher rate of comorbidities, high risk features, concomitant interacting medications, and prior chemotherapy. Further studies are warranted to determine if growth factor support is efficacious to achieve dose escalation with this therapy.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
EFFICACY AND SAFETY OF OBINUTUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS WITH SECONDARY NON-RESPONSE TO RITUXIMAB. () - May 24, 2022 - Abstract #EULAR2022EULAR_3398;
Obinutuzumab was shown to be effective in patients with severe renal and non-renal disease. Therefore, in those with previous responsiveness to B-cell depletion, switching to humanised type-2 anti-CD20 therapy is a logical approach following loss off efficacy.
- |||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Aliqopa (copanlisib) / Bayer
New P2 trial, Combination therapy: Alternative-C: A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden (clinicaltrials.gov) - May 23, 2022
P2, N=98, Recruiting, Sponsor: Ludwig-Maximilians - University of Munich
- ||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Trial completion date, Metastases: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) (clinicaltrials.gov) - May 23, 2022
P3, N=1401, Completed, Sponsor: Hoffmann-La Roche
Therefore, in those with previous responsiveness to B-cell depletion, switching to humanised type-2 anti-CD20 therapy is a logical approach following loss off efficacy. Trial completion date: Nov 2021 --> Jul 2021
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Obinutuzumab in Kidney Transplantation: Effect on B-cell Counts and Crossmatch Tests (Hynes Halls C & D: Board No. B131) - May 20, 2022 - Abstract #ATC2022ATC_2481;
*Purpose: Resistance to the action of rituximab (RTX), has been documented in several diseases. OBZ effectively depletes B-cell counts in sensitized kidney transplant candidates and, unlike RTX, has no effect on CDC crossmatch results.
- ||| Clinical: Chlorambucil has served as a comparator in trials of bendamustine, alemtuzumab, ofatumumab, and obinutuzumab. The use of single-agent chlorambucil appears to be a poorly justified and, in clinical practice, infrequently used choice of control. https://t.co/odQkVuPZNF (Twitter) - May 18, 2022
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial initiation date: FORTplus: Early Stage Follicular LymphOma and RadioTherapy PLUS Anti-CD20 Antibody (clinicaltrials.gov) - May 17, 2022
P3, N=100, Not yet recruiting, Sponsor: Heidelberg University
OBZ effectively depletes B-cell counts in sensitized kidney transplant candidates and, unlike RTX, has no effect on CDC crossmatch results. Initiation date: Dec 2021 --> Jun 2022
- | Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
New P2 trial: PR3-AAV Resilient Remission or PRRR (clinicaltrials.gov) - May 17, 2022
P2, N=30, Not yet recruiting, Sponsor: Mayo Clinic
- || Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Retrospective data, Review, Journal: Case Report: Use of Obinutuzumab as an Alternative Monoclonal Anti-CD20 Antibody in a Patient With Refractory Immune Thrombocytopenia Complicated by Rituximab-Induced Serum Sickness and Anti-Rituximab Antibodies. (Pubmed Central) - May 14, 2022
Additionally, a review of 10 previously published cases of serum-sickness associated with the use of rituximab for idiopathic thrombocytopenic purpura (ITP) is summarized. This case highlights that recognition of more subtle or rare symptoms of rituximab-induced serum sickness is important to facilitate rapid intervention.
- B-CELL MALIGNANCIES TREATED WITH TARGETED DRUGS AND SARS-COV-2 INFECTION. A EUROPEAN HEMATOLOGY ASSOCIATION SURVEY (EPICOVIDEHA) (Hall Strauss 1-2) - May 13, 2022 - Abstract #EHA2022EHA_2722;
Aims The aim of this study is to describe and analyse the outcome of COVID-19 patients with underlying LPD treated with targeted drugs such as monoclonal antibodies (obinutuzumab, ofatumumab, brentuximab, nivolumab or pembrolizumab), BTK inhibitors (ibrutinib, acalabrutinib), PI3K inhibitors (idelalisib), BCL2 inhibitors (venetoclax) and IMIDs, (lenalidomide)...Most used targeted drugs were ITKs (51.1%), anti-CD20 other than rituximab (16%), BCL2 inhibitors (7.3%) and lenalidomide (7.9%)...- COVID-19 vaccination was a protective factor for mortality, even in this population with humoral immunity impairment. - The learning curve in the management of the infection throughout the pandemic and the development of COVID-19 treatments showed benefit in this particularly vulnerable population.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
OBINUTUZUMAB PLUS CHEMOTHERAPY DEMONSTRATES LONG-TERM BENEFIT OVER RITUXIMAB PLUS CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA: FINAL ANALYSIS OF THE GALLIUM STUDY (Hall C1) - May 13, 2022 - Abstract #EHA2022EHA_2714;
P3
These safety findings are consistent with previous analyses. Conclusion After a median observation time of 8 years, a meaningful improvement in PFS was maintained with G-chemo versus R-chemo in pts with previously untreated FL, confirming the role of G-chemo as a standard of care for the first-line treatment of pts with FL.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
LONG TERM OUTCOMES OF IFCG REGIMEN FOR FIRSTLINE TREATMENT OF PATIENTS WITH CLL WITH MUTATED IGHV AND WITHOUT DEL(17P)/TP53 MUTATION (Hall A8) - May 13, 2022 - Abstract #EHA2022EHA_2670;
P2
The 5-year PFS is 97.7%; this is favorable compared to 5-year PFS of ≈65% with FCR (CLL10), ≈70% with ibrutinib (A041202 trial), and 81% with ibrutinib (RESONATE-2) for IGHV-M CLL. Not unexpectedly, MRD recurrence during follow-up correlated with MRD positivity by NGS during therapy.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
VENETOCLAX-OBINUTUZUMAB FOR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA: 5-YEAR RESULTS OF THE RANDOMIZED CLL14 STUDY (Hall A8) - May 13, 2022 - Abstract #EHA2022EHA_2669;
The majority of patients treated with Ven-Obi still have not required a second line of CLL therapy. Hence, the 1-year Ven-Obi regimen continues to be an effective fixed-duration option for patients with CLL and coexisting conditions, also in the context of high-risk disease.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
TRANSCRIPTOMIC CHARACTERIZATION OF MRD RESPONSE AND NON-RESPONSE IN PATIENTS TREATED WITH FIXED-DURATION VENETOCLAX-OBINUTUZUMAB (Hall Stolz 1-2) - May 13, 2022 - Abstract #EHA2022EHA_2659;
Response and non-response to therapy, as assessed by NGS-based MRD status, was associated with a distinct transcriptomic profile that was characterized by upregulated oncogenic pathways and inflammatory signaling, respectively. These data suggest possible biological vulnerabilities that could be leveraged to overcome resistance to venetoclax.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN FIRST LINE CHRONIC LYMPHOCYTIC LEUKEMIA IN ARGENTINA: A COST-EFFECTIVENESS ANALYSIS () - May 13, 2022 - Abstract #EHA2022EHA_2297;
Other comparators included treat-to-progression therapies, such as ibrutinib (IBR), and a 6-month course of bendamustine + rituximab (BR)...Thus, VenG with a 12-month fixed duration, has lower total costs and is more efficacious ("dominant") over all comparators in the CEM. OWSA analyses show that the results are robust, and in the PSA VenG is dominant over all the comparators considered, ICER is ≤$ 6,011.20 (1 GDP per capita for Argentina, 2020), /QALY in 97% of the iterations CE Results Conclusion This study shows that in Argentina, VenG would be dominant treatment option (better results and lower costs) compared with ClbG, BR and IBR in the treatment of first-line unfit CLL patients.
- Venclexta (venetoclax) / Roche, AbbVie
HEALTHCARE RESOURCE UTILIZATION AND COSTS OFF THERAPY WITH FIXED-DURATION VENETOCLAX AMONG CLL PATIENTS () - May 13, 2022 - Abstract #EHA2022EHA_2275;
These preliminary results suggest that fixed treatment duration therapy allows patients to experience off-therapy economic benefits. Further exploration should be undertaken in a larger cohort of patients.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
ZANUBRUTINIB + OBINUTUZUMAB (ZO) VS OBINUTUZUMAB (O) MONOTHERAPY IN PATIENTS (PTS) WITH RELAPSED OR REFRACTORY (R/R) FOLLICULAR LYMPHOMA (FL): PRIMARY ANALYSIS OF THE PHASE 2 RANDOMIZED ROSEWOOD TRIAL (Hall C1) - May 13, 2022 - Abstract #EHA2022EHA_1890;
P2
Conclusion ZO demonstrated superior efficacy to O in treatment of pts with R/R FL. ZO had a favorable benefit-risk profile and represents a potential combination therapy for pts with R/R FL.
- glofitamab (RG6026) / Roche
GLOFITAMAB INDUCES DURABLE COMPLETE REMISSIONS AND HAS FAVORABLE SAFETY IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA AND ≥2 PRIOR THERAPIES: PIVOTAL PHASE II EXPANSION RESULTS (Hall C1) - May 13, 2022 - Abstract #EHA2022EHA_1885;
P1/2
Conclusion Fixed-duration glofitamab induces durable complete remissions and has favorable safety in patients with R/R DLBCL and ≥2 prior therapies, including those with prior exposure to CAR-Ts. Glofitamab is a promising new therapy for patients with heavily pretreated and/or highly refractory DLBCL.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
ACALABRUTINIB ± OBINUTUZUMAB VS OBINUTUZUMAB + CHLORAMBUCIL IN TREATMENT-NAIVE CHRONIC LYMPHOCYTIC LEUKEMIA: 5-YEAR FOLLOW-UP OF ELEVATE-TN () - May 13, 2022 - Abstract #EHA2022EHA_1849;
P3
Crossover from O+Clb to A occurred in 72 (41%) patients; 25% of these patients discontinued A (10% due to AEs and 11% due to progressive disease). Conclusion After 5 years of follow-up, efficacy and safety of A+O and A monotherapy were maintained, with significantly longer OS in the A+O arm compared with O+Clb.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
INFLUENCE OF ANTI-CD20 MONOCLONAL ANTIBODY THERAPY ON THE OUTCOME OF CORONAVIRUS INFECTION COVID-19 IN PATIENTS WITH LYMPHOPROLIFERATIVE DISEASES () - May 13, 2022 - Abstract #EHA2022EHA_1591;
The 30-day in-hospital survival in patients who received anti-CD20 monoclonal antibody therapy within the last 12 months was 62%, in patients who received anti-CD20 monoclonal antibody therapy more than 12 months ago this was not achieved (p=0,042). Conclusion An increase in the number of deaths from COVID-19 and a longer persistence of the virus SARS-CoV-2 are experienced among patients with lymphoproliferative diseases who have received anti-CD20 monoclonal antibody therapy within the last 12 months before hospitalization ; all this negatively affect in-hospital survival.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
EFFICACY AND SAFETY OF IMMUNOCHEMOTHERAPY IN TREATMENT OF FOLLICULAR NON-HODGKIN'S LYMPHOMA DURING COVID-19 PANDEMIC: A STUDY OF KROHEM, THE CROATIAN COOPERATIVE GROUP FOR HEMATOLOGIC DISEASES () - May 13, 2022 - Abstract #EHA2022EHA_1509;
These intriguing differences could play important role in treatment approach in COVID-19 pandemic. Future studies investigating hematological malignancies in COVID-19 pandemic are warranted.
- parsaclisib (INCB50465) / Incyte, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
A PHASE 1 STUDY EVALUATING SAFETY AND EFFICACY OF PARSACLISIB IN COMBINATION WITH BENDAMUSTINE + OBINUTUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (CITADEL-102) () - May 13, 2022 - Abstract #EHA2022EHA_1504;
P1
Median DOR, PFS, and OS were not reached. Conclusion Parsaclisib in combination with bendamustine + obinutuzumab appears to have a manageable safety profile and demonstrated promising efficacy in pts with R/R FL.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
OUTCOME OF FOLLICULAR LYMPHOMA PATIENTS IN MAINTENANCE TREATMENT WITH ANTICD20 MONOCLONAL ANTIBODIES IN SARS-COV2 ERA: RESULTS FROM A MULTICENTER, RETROSPECTIVE- PROSPECTIVE ITALIAN STUDY. () - May 13, 2022 - Abstract #EHA2022EHA_1499;
A trend in lower mortality is suggested. No differences in terms of relapse rate were observed, but longer follow up is needed.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
STUDY CONDUCT AND PATIENT SAFETY DURING THE COVID-19 PANDEMIC: OBSERVATIONS IN PATIENTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA FROM THE GAZELLE TRIAL OF OBINUTUZUMAB SHORT DURATION INFUSION () - May 13, 2022 - Abstract #EHA2022EHA_1489;
P4
Documented COVID-19 infections occurred in 5 pts and fatal outcomes were reported in 2 of these pts (both unvaccinated). Up to 7 days after COVID-19 vaccination, no AEs considered related to obinutuzumab or other study treatments were observed.
- Venclexta (venetoclax) / Roche, AbbVie
IBRUTINIB PLUS VENETOCLAX IN PATIENTS WITH COMPLEX KARYOTYPE AND CHRONIC LYMPHOCYTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_1273;
PFS in both groups is currently not significantly different, which is obviously due to the short follow-up period. Patients receiving the IVen regimen achieve a significantly better response, which paves the way for allogeneic transplantation in these patients.