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- 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.
- EUROFLOW STANDARDIZATION TECHNIQUE AND NORMALIZATION PROCEDURES IN LONGITUDINAL FLOW CYTOMETRIC EXPRESSION ANALYSIS OF CD20 IN CLL PATIENTS RECEIVING ANTI-CD20 DIRECTED THERAPY () - May 13, 2022 - Abstract #EHA2022EHA_1267;
Conclusion Following standardized staining and instrument monitoring, it should be possible to robustly assess longitudinal biological variations of marker expression based on MFI values. In a cross trial comparison Obinutzumab showed highest proportion of patients with strong MRD response independent from initial CD20 expression, whereas strong response to Ofatumumab seems to correlate with higher CD20 expression levels.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
UPDATED RESULTS OF A PHASE 1B STUDY OF IBRUTINIB (IBR) PLUS OBINUTUZUMAB (OBIN) IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) () - May 13, 2022 - Abstract #EHA2022EHA_1265;
P1
With ~3.5 yrs median follow-up, and some pts on tx over 6 yrs, cardiotoxicity was consistent with prior ibr studies, and no new safety concerns have emerged. Our data support continued exploration of combination BTK inhibitor plus obin in R/R CLL.
- Calquence (acalabrutinib) / AstraZeneca
LONG-TERM EFFICACY OF ACALABRUTINIB-BASED REGIMENS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND HIGHER-RISK GENOMIC FEATURES: POOLED ANALYSIS OF CLINICAL TRIAL DATA () - May 13, 2022 - Abstract #EHA2022EHA_1252;
Conclusion In this pooled analysis of clinical trial data in 801 CLL pts with higher-risk genomic features, efficacy of A-based regimens led to high PFS and OS rates at a median follow-up of nearly 4 y. The safety profile in this analysis was similar to the overall safety profile of acalabrutinib. Our results demonstrate the long-term benefit of A-based regimens in CLL pts with higher-risk genomic features, regardless of line of therapy.
- Calquence (acalabrutinib) / AstraZeneca
CARDIAC ADVERSE EVENTS AND SECOND PRIMARY MALIGNANCIES WITH ACALABRUTINIB IN CHRONIC LYMPHOCYTIC LEUKEMIA -A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS () - May 13, 2022 - Abstract #EHA2022EHA_1251;
In the ELEVATE -TN study, the comparator arm included the combination of chlorambucil and Obinutuzumab...Conclusion There is no increase in risk of atrial fibrillation with the acalabrutinib based regimens as compared to the non-acalabrutinib – based therapies; however, there was a significantly increased risk of HTN. There is lower risk of SPM and non-melanoma SPM in the acalabrutinib based regimens than the control arm.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
RETREATMENT WITH VENETOCLAX AFTER VENETOCLAX, OBINUTUZUMAB +/- IBRUTINIB: POOLED ANALYSIS OF 13 PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) TREATED IN GCLLSG TRIALS () - May 13, 2022 - Abstract #EHA2022EHA_1232;
Current clinical trials also combine Ven-G with ibrutinib (GIVe) or acalabrutinib (GAVe) to increase efficacy and possibly shorten treatment duration with minimal residual disease (MRD)-guided discontinuation strategies...V2 was GAVe in 9 pts, including 2 with a bendamustine debulking, and Ven-G or Ven in 2 each, all with a MRD-guided discontinuation...1. Conclusion In this pooled analysis of 13 pts with two consecutive time-limited V-containing therapies, which includes mainly pts with adverse risk factors and a short remission duration, V-based re-treatment appeared to be safe and efficacious: no increased rate of AEs was seen so far and all pts responded with at least 2/3 even achieving uMRD again.
- FRONTLINE THERAPY CLL WITHOUT 17P DEL/P53 ABERRATIONS: SYSTEMATIC REVIEW AND BAYESIAN NETWORK META-ANALYSIS () - May 13, 2022 - Abstract #EHA2022EHA_1228;
The combination ACA-O has the highest probability to be the best treatment for prolonging the PFS in untreated, UN/MU-only CLL patients. ACA monotherapy is a valuable alternative considering both the safety and efficacy profile.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
EFFICACY OF FIRST-LINE TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA: A BAYESIANNETWORK META-ANALYSIS. () - May 13, 2022 - Abstract #EHA2022EHA_1224;
P3, P4
Results from this indirect treatment comparison suggested that the PFS for zanubrutinib may be statistically significantly better than immunochemotherapy. Findings from this study require validation with further large scale RCTs with longer follow up time.
- Calquence (acalabrutinib) / AstraZeneca
TIME-LIMITED TREATMENT WITH ACALABRUTINIB PLUS OBINOTUZUMAB IN TREATMENT-NAÏVE CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS INDUCES DEEP REMISSIONS: EARLY RESULTS OF AN ONGOING PHASE 2 TRIAL. () - May 13, 2022 - Abstract #EHA2022EHA_1220;
P2
Conclusion Our preliminary data indicate that combination therapy of acalabrutinib plus obinotuzumab induces remissions with a major reduction in bone marrow disease after 6 months of combination therapy. Longer treatment and follow-up is warranted to determine the durability of responses after therapy discontinuation.
- ADJUSTING SURVIVAL DATA FOR TREATMENT CROSSOVER IN THE ELEVATE-TN TRIAL BY USING A HISTORICAL COHORT OF PATIENTS TREATED WITH CHEMOIMMUNOTHERAPY IN FRONT-LINE CHRONIC LYMPHOCYTIC LEUKEMIA () - May 13, 2022 - Abstract #EHA2022EHA_1214;
ELEVATE-TN trial interim data (~47 months median follow-up [FU]) did not show survival benefit for A±obinutuzumab (O) versus chlorambucil+obinutuzumab (C+O) despite significantly superior progression-free survival (PFS)...Methods The CLL11 trial demonstrated superior PFS and OS for C+O versus C and C+rituximab in first-line CLL prior to BTKi availability...Conclusion The non-statistically significant OS for A±O versus C+O was likely due to treatment crossover. Conducting a treatment-switching analyses was challenging due to immature OS data; however, this analysis supports the hypothesis that crossover to A bolstered ELEVATE-TN C+O OS.
- Calquence (acalabrutinib) / AstraZeneca
ACALABRUTINIB RELATED INFECTIOUS COMPLICATIONS-A SYSTEMATIC REVIEW AND META-ANALYSIS OF PHASE III RCT () - May 13, 2022 - Abstract #EHA2022EHA_1213;
In the ELEVATE -TN study the comparator arm included the combination of chlorambucil and obinutuzumab...We noted a substantial heterogeneity across trials included in our analysis. Conclusion Our meta-analysis demonstrated that patients on acalabrutinib-containing regimens experienced a significantly lower relative risk of infections compared to non-acalabrutinib-based therapies. There were significantly lower risks of URTI and infection related treatment discontinuations with acalabrutinib therapy in patients with CLL.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
RESPONSE TO NOVEL ANTI CD20 ANTIBODY AND BCL2 INHIBITOR IN A PATIENT WITH CLL AND MEMBRANOPROLIFERATIVE GLOMERULONEPHRITIS ASSOCIATED WITH LEUKEMIC KIDNEY INFILTRATION AND REVIEW OF LITERATURE () - May 13, 2022 - Abstract #EHA2022EHA_1203;
Until today the patient followed 4 cycles of OV with complete remission of CLL and complete response of his underlying MPGN and leukemic renal infiltration. Conclusion Of all the cases in the literature, our approach to this condition was different, choosing Obinutuzumab and Venetoclax therapy, obtaining the complete response after the first cycle.
- Venclexta (venetoclax) / Roche, AbbVie
BCL2 RESISTANCE MUTATIONS IN A REAL-WORLD COHORT OF PATIENTS WITH VENETOCLAX-TREATED CHRONIC LYMPHOCYTIC LEUKAEMIA () - May 13, 2022 - Abstract #EHA2022EHA_1177;
In patients harboring multiple BCL2 mutations, convergent evolution of the CLL subclones may contribute to the driver mechanisms of resistance, justifying the comprehensive approach for the detection of these variants. In secondary venetoclax resistant cases displaying wild type BCL2 , further molecular screening methods are required to reveal alternative genetic or non-genetic reasons for disease progression.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
CLINICOBIOLOGICAL CHARACTERISTICS AND TREATMENT EFFICACY OF NOVEL AGENTS IN CHRONIC LYMPHOCYTIC LEUKEMIA WITH IGLV3-21R110 () - May 13, 2022 - Abstract #EHA2022EHA_1171;
Our results suggest that novel targeted therapies may mitigate the adverse risk profile of IGLV3-21 R110 CLL. To determine whether these patients should preferentially receive novel therapies, characterization of the predictive impact of IGLV3-21 R110 in the setting of chemoimmunotherapy is warranted.
- glofitamab (RG6026) / Roche
REAL-WORLD EXPERIENCE OF OUTCOMES WITH GLOFITAMAB SALVAGE THERAPY FOR RELAPSE/REFRACTORY B-CELL LYMPHOMA IN TAIWAN: MINIMAL SAFETY CONCERN WITH HEPATITIS B REACTIVATION () - May 13, 2022 - Abstract #EHA2022EHA_1059;
The treatment protocol included obinutuzumab pretreatment 1000mg given 7 days before the first glofitamab dose, followed by step-up dose of glofitamab administration: 2.5mg on Day 1 and 10mg on Day 8 of cycle 1, and then 30mg on Day 1 of cycle 2-12 (21-day cycles)...All patients had received prior rituximab therapy, 6(23%), autologous or allogeneic stem cell transplantation (SCT), and 9(35%), polatuzumab salvage...No new safety issues were observed. With optimal prophylaxis, the risk of HBV reactivation would not be of concern during glofitamab treatment.
- glofitamab (RG6026) / Roche
IMMUNE CORRELATES OF RESPONSE TO GLOFITAMAB: BIOMARKER FINDINGS FROM A PIVOTAL PHASE II EXPANSION STUDY IN PATIENTS WITH RELAPSED OR REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) () - May 13, 2022 - Abstract #EHA2022EHA_1039;
P1/2
Several novel response-associated biomarkers were identified in PB including higher BL B cell, CD4, and CD4 EM counts in responders and higher PD1 expression on CD8 in pts with PD. These data suggest a model where the clinical activity of glofitamab may be dependent upon immune contexture in the tumor and PB at the start of treatment.
- OUTCOMES OF COVID-19 INFECTION IN PATIENTS WITH B AND PLASMA CELL MALIGNANCIES DURING THE THIRD WAVE IN ARGENTINA: A SINGLE CENTER EXPERIENCE () - May 13, 2022 - Abstract #EHA2022EHA_1570;
Nearly half of the pts had received a B-cell-depleting monoclonal antibody-based regimen: Rituximab (n=13), Daratumumab (n=4) or Obinutuzumab (n=1); the other half: other anti-myeloma therapy (n=5), chemotherapy (n=3), Ibrutinib (n=3), Venetoclax (n=2) or were untreated (n=7)...Twelve pts were treated with convalescent plasma, 9 received corticosteroids and 1 tocilizumab...Our findings show lower fatality rate than reported in previous waves, but still higher than the general vaccinated population. This might be explained because even if fully vaccinated, responsive patients fail to achieve protective levels of anti-spike antibodies.
- Arzerra (ofatumumab) / Novartis, Genmab, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
The use of Obinutuzumab and Ofatumumab in the treatment of immune Thrombotic Thrombocytopenic Purpura (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_842;
21/26 episodes were pre-emptive treatment in ADAMTS13 relapses, 4/26 episodes were as part of treatment for clinical relapses and 1/26 episode was during the acute presentation period. All patients had previously received rituximab but was clinically felt inappropriate for further treatments - 12/15 had rituximab-induce serum sickness, 1/15 had acute drug intolerance and 2/15 had short duration of response to rituximab.
- || Keytruda (pembrolizumab) / Merck (MSD)
Clinical, Journal: Pembrolizumab treatment of inflammatory progressive multifocal leukoencephalopathy: a report of two cases. (Pubmed Central) - May 12, 2022
We present two cases of non-HIV, non-MS patients with PML who were treated with pembrolizumab with little clinical benefit. The literature surrounding pembrolizumab use in PML is discussed, with a focus on potential indicators of successful outcomes for patients who receive this therapy.
- |||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open: A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL (clinicaltrials.gov) - May 10, 2022
P3, N=650, Recruiting, Sponsor: German CLL Study Group
The literature surrounding pembrolizumab use in PML is discussed, with a focus on potential indicators of successful outcomes for patients who receive this therapy. Not yet recruiting --> Recruiting
- | Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, magrolimab (GS-4721) / Ono Pharma
Enrollment open: Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (clinicaltrials.gov) - May 9, 2022
P1, N=76, Recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Suspended --> Recruiting
- || Benlysta (belimumab) / GSK, Lupkynis (voclosporin) / Aurinia Pharma, Otsuka, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Innovations in the pharmaceutical treatment of systemic lupus erythematosus (Pubmed Central) - May 6, 2022
New and innovative treatment concepts are finding their way into lupus treatment and other promising substances are in the pipeline; however, only long-term data will show to what extent these improve the long-term outcome of patients. Nevertheless, these are important and much needed advances in the treatment of SLE.
- || Columvi (glofitamab-gxbm) / Roche, Rituxan (rituximab) / Roche
New P1 trial, Combination therapy: GO43693: A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma (clinicaltrials.gov) - May 6, 2022
P1, N=40, Not yet recruiting, Sponsor: Hoffmann-La Roche
- | golcadomide (CC-99282) / BMS
Trial primary completion date, Combination therapy: A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (clinicaltrials.gov) - May 5, 2022
P1b, N=50, Recruiting, Sponsor: Celgene
Nevertheless, these are important and much needed advances in the treatment of SLE. Trial primary completion date: Jun 2024 --> Nov 2024
- || Review, Journal: Strategies for Glycoengineering Therapeutic Proteins. (Pubmed Central) - May 3, 2022
This article provides illustrative examples of drugs that have already been improved through glycoengineering including cytokines exemplified by erythropoietin (EPO), enzymes (ectonucleotide pyrophosphatase 1, ENPP1), and IgG antibodies (e.g., afucosylated Gazyva, Poteligeo, Fasenra™, and Uplizna). In the future, the deliberate modification of therapeutic protein glycosylation will become more prevalent as glycoengineering strategies, including sophisticated computer-aided tools for "building in" glycans sites, acceptance of a broad range of production systems with various glycosylation capabilities, and supplementation methods for introducing non-natural metabolites into glycosylation pathways further develop and become more accessible.
- ||| Brukinsa (zanubrutinib) / BeiGene
Enrollment open: ARIADNE: Zanubrutinib in Patients With Waldenstr (clinicaltrials.gov) - May 3, 2022
P=N/A, N=150, Recruiting, Sponsor: iOMEDICO AG
In the future, the deliberate modification of therapeutic protein glycosylation will become more prevalent as glycoengineering strategies, including sophisticated computer-aided tools for "building in" glycans sites, acceptance of a broad range of production systems with various glycosylation capabilities, and supplementation methods for introducing non-natural metabolites into glycosylation pathways further develop and become more accessible. Not yet recruiting --> Recruiting
- || Avastin (bevacizumab) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical, Journal: TRAIL Score: A Simple Model to Predict Immunochemotherapy Tolerability in Patients With Diffuse Large B-Cell Lymphoma. (Pubmed Central) - Apr 30, 2022
Not yet recruiting --> Recruiting TRAIL may be useful as a clinical decision support tool for treatment decisions in patients with DLBCL who may not tolerate standard chemoimmunotherapies.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Efficacy of first-line treatment for chronic lymphocytic leukemia: A Bayesian network meta-analysis. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6237;
P3, P4
Results from this indirect treatment comparison suggested that the PFS for zanubrutinib may be statistically significantly better than immunochemotherapy. Findings from this study require validation with further large scale RCTs with longer follow up time.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical impact of SARS-CoV-2 delta variant infection in tumor patients and the impact of vaccination on different cancer treatment regimens. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6154;
In this period, a total of 1.227 patients were tested for SARS-CoV-2 by RT-qPCR. 78/1227 patients (6.3%) were tested positive in RT-qPCR and most showed mild symptoms of infection.
- glofitamab (RG6026) / Roche
Glofitamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and ≥ 2 prior therapies: Pivotal phase II expansion results. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_5335;
P1/2
Fixed-duration glofitamab induces durable complete remissions and has favorable safety in pts with R/R DLBCL and ≥2 prior therapies, including those with prior exposure to CAR-Ts. Glofitamab is a promising new therapy for pts with heavily pretreated and/or highly refractory DLBCL.
- ibrutinib / Generic mfg.
Characteristics and clinical outcomes among patients receiving either ibrutinib or anti-CD20 monotherapy as first-line (1L) treatment for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL): A retrospective analysis in community oncology practice. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_4342;
Despite ibrutinib established as a preferred first-line (1L) treatment option, anti-CD20 monotherapy (rituximab or obinutuzumab) has been prescribed as symptomatic or palliative therapy. IPTW-adjusted analysis showed that in the real-world community practice setting, treatment with ibrutinib resulted in a statistically significantly lower risk of initiating subsequent treatment than the anti-CD20 group including patients with high cytogenetic risk features and without IGHV testing.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Outcome of follicular lymphoma (FL) patients in maintenance with antiCD20 monoclonal antibodies (MoAb) in SARS-Cov2 era. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_2733;
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, Tecentriq (atezolizumab) / Roche
Frontline treatment of follicular lymphoma with atezolizumab and obinutuzumab, with and without radiotherapy (The FLUORO study). (Available On Demand; 235a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2692;
P2
Overall response rates (ORR) to standard chemoimmunotherapy (bendamustine or CHOP with rituximab or obinutuzumab) approximate 85% with considerable toxicity (grade 3-5 in 69-75%) (Hiddemann 2018)...Our phase II ‘1st FLOR’ study, combining nivolumab + rituximab in treatment naïve FL yielded 92% ORR, (54% Complete Response, CR)...Sample size is 46 according to a Simon’s 2-stage design. If ≥5 positive responses (CR +/- PR) without prohibitive toxicity are seen in the first 15 pts, 31 further pts will be recruited.The trial has currently enrolled 7 pts from 4 Australian sites.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Long-term outcomes and circulating tumor DNA analysis from a phase I/II study of lenalidomide and obinutuzumab with CHOP for newly diagnosed diffuse large B-cell lymphoma. (Available On Demand; 206) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2659;
P1/2
LOCHOP demonstrates high efficacy and tolerability in newly diagnosed DLBCL, leading to a high rate of undetectable minimal residual disease by ctDNA. Noninvasive molecular subtyping is feasible as a supplement to tissue diagnosis and should be incorporated in future studies aiming to improve on RCHOP.
- Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Four-year follow-up from a phase 2 study of obinutuzumab, ibrutinib, and venetoclax in CLL. (Available On Demand; 193) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2646;
P1/2
At extended follow-up, remissions remain durable after fixed duration OBIN, IBR, and VEN. The efficacy and acceptable safety justify further study and are being compared to IBR and OBIN in 2 phase 3 US cooperative group trials.
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN. (Available On Demand; 192) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2645;
P3
The efficacy and acceptable safety justify further study and are being compared to IBR and OBIN in 2 phase 3 US cooperative group trials. After a 5-y 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.
- Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) monotherapy in patients (pts) with relapsed or refractory (R/R) follicular lymphoma (FL): Primary analysis of the phase 2 randomized ROSEWOOD trial. (Available On Demand; 164) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2613;
P2
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
PK/PD data, Preclinical, Journal: Novel In Vivo and In Vitro Pharmacokinetic/Pharmacodynamic-Based Human Starting Dose Selection for Glofitamab. (Pubmed Central) - Apr 26, 2022
P1/2
FIH starting dose (5 µg) was selected based on IL-6 release considering the markedly higher glofitamab in vitro potency in human vs monkey blood. This is a novel PKPD-based approach for selection of FIH starting dose for a CD20xCD3 bispecific antibody in B-cell lymphoma, evidenced in the glofitamab study, NP30179 (NCT03075696).
- Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Real-World Experience of Rapid Obinutuzumab Administration: Time to Change Obinutuzumab Infusion Rates () - Apr 25, 2022 - Abstract #BSH2022BSH_105;
Rapid obinutuzumab infusions are well tolerated in selected patients from cycle 2 onwards and this change in practice has the potential to lead to meaningful improvements to chemotherapy unit capacity during this period of persistent strain on healthcare systems. We advocate for review of obinutuzumab administration guidance for lower-risk patients in light of growing evidence to demonstrate the safety and utility of rapid infusions.