- |||||||||| Bispecifi c Antibodies for Aggressive B-Cell Lymphoma () - Sep 22, 2022 - Abstract #SOHO2022SOHO_390;
P1, P1/2,
NCT03533283 and or mosunetuzumab, NCT03677154); and lenalidomide or the CElMoDs (NCT05169515, NCT05335018, NCT02568553)...Data from arm 1 of this study using fi rst-line epcoritamab+R-CHOP for high-risk DLBCL has demonstrated an overall response rate of 96%.2 A cohort of transplant-eligible R/R DLBCL patients who received salvage epcoritamab+R-DHAX/C with subsequent ASCT or epcoritamab monotherapy demonstrated OR and CR rates of 82.6% and 60.9%...Conclusion Clinical data indicate that BsAbs will earn a place in regular treatment of relapse aggressive lymphoma. There is broad development potential in earlier lines of therapy and as a salvage following CAR-T cell therapy.
- |||||||||| Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Clinical Signifi cance of B-Cell Receptor Stereotype in CLL () - Sep 22, 2022 - Abstract #SOHO2022SOHO_386;
This suggests that CIT may be less optimal for subset #2 patients, while also highlighting the usefulness of this information for risk stratifi cation of patients, a practice already followed by different study groups worldwide. In that regard, it is relevant to mention the results of the NCRI FLAIR trial, where a hazard ratio for disease progression and death of 0.32 was reported for subset #2 patients treated with FCR versus IR, though not reaching statistical signifi cance (p =0.191), likely due to low numbers (FCR, n =20; IR, n =26).21 Subset #8 includes patients with U-CLL expressing BcR IG encoded by the IGHV4-39/IGKV1(D)-39 genes with distinctive, restricted VH and VK CDR3 sequences.22,23 Subset #8 displays a signifi cant enrichment for trisomy 12 and NOTCH1 mutations, offering yet another example of subset-biased profi les of genomic aberrations.11-13,15 In the original report of subset #8 it was noted that 2 of 5 patients belonging to subset #8 experienced Richter’s transformation.22 This initial observation was subsequently corroborated by a collaborative study from Italy reporting that patients belonging to subset #8 had a 10-fold higher risk for this development compared to all other patients with CLL.17 Subsequently, the meta-analysis of 3 prospective clinical trials conducted by the German CLL Study Group showed that patients belonging to subset #8 experienced the highest risk of Richter’s transformation, albeit the incidence was lower.16 On these grounds, ERIC, the European Research Initiative on CLL, recommends closer follow-up and a lower threshold for a fl uorodeoxyglucose positron emission tomography (PET)/ CT guided biopsy for subset #8 patients experiencing evidence of disease progression (also under therapy) in order to exclude the possibility of Richter’s transformation.24
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Review, Journal, IO biomarker: Management of front line chronic lymphocytic leukemia. (Pubmed Central) - Sep 22, 2022
Although these agents have usually manageable side effects, toxicities might limit choices for the individual patient. We here discuss latest trial data and propose a treatment algorithm for frontline treatment of CLL according to fitness and relevant genetic risk factors like IGHV mutational status and TP53 aberrations.
- |||||||||| Benlysta (belimumab) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: B cells in systemic lupus erythematosus: Targets of new therapies and surveillance tools. (Pubmed Central) - Sep 20, 2022
In addition, terminally differentiated B cells have also been the targets of experimental therapies, with the proteasome inhibitor bortezomib being one example...Inadequate B cell depletion may signify poor expected clinical response to rituximab, for example, while prominent reductions in certain B cell subsets may signify a protection against flare development in patients treated with belimumab. Toward an era with a richer therapeutic armamentarium in SLE, including to a large extent B cell altering treatments, the challenge that emerges is to determine diagnostic means for evidence-based therapeutic decision-making, that uses clinical information, serological markers, and gene expression patterns to guide individualized precision strategies.
- |||||||||| Darzalex (daratumumab) / J&J
Daratumumab enables sustained remission after Immunoadsorption in Refractory Multidrug Resistant Nephrotic Syndrome. (Poster Area - Exhibition Hall E) - Sep 20, 2022 - Abstract #IPNA2022IPNA_432;
All were resistant to ciclosporine and/or tacrolimus, 4 also received MMF and 3 rituximab (RTX)...All patients achieved complete remission after IA but relapsed after a first discontinuation attempt, despite B-cell depletion with RTX(n=3) or Obinutuzumab (OBI) (n=3)...The association of plasma-cell depletion with daratumumab to B-cell depletion allowed IA discontinuation in all patients. Further studies are needed to confirm the efficacy of daratumumab in children with MRNS and better define its place in the treatment strategy.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date: Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG) (clinicaltrials.gov) - Sep 16, 2022
P2, N=66, Active, not recruiting,
This study will address key unanswered questions in frontline chronic lymphocytic leukemia/small lymphocytic lymphoma therapy by investigating the optimal duration of finite treatment and identifying the optimal venetoclax doublet regimen. Trial completion date: Sep 2022 --> Nov 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Review, Journal: A Biphasic COVID-19 Clinical Course in Anti-CD20 Treated Patients: Case Series and Review of the Literature. (Pubmed Central) - Sep 14, 2022
Trial completion date: Sep 2022 --> Nov 2024 Four cases of COVID-19 infection in anti-CD20 treated patients are described.These cases display a unique biphasic course that was previously undescribed: respiratory deterioration weeks after convalescence.Awareness of such a course and rapid utilisation of bronchoalveolar lavage will lead to quicker diagnosis and more timely, appropriate treatment.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date: NOBILITY: A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) (clinicaltrials.gov) - Sep 14, 2022
P2, N=126, Active, not recruiting,
Four cases of COVID-19 infection in anti-CD20 treated patients are described.These cases display a unique biphasic course that was previously undescribed: respiratory deterioration weeks after convalescence.Awareness of such a course and rapid utilisation of bronchoalveolar lavage will lead to quicker diagnosis and more timely, appropriate treatment. Trial completion date: Jul 2022 --> Oct 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
PARTIAL ANOMALOUS PULMONARY VENOUS CONNECTION DIAGNOSED AFTER CENTRAL VENOUS CATHETER PLACEMENT (Convention Center Exhibit Hall: Rapid Area 2B) - Sep 11, 2022 - Abstract #CHEST2022CHEST_4186;
CASE PRESENTATION: A 71-year old male with chronic lymphocytic leukemia was admitted with distributive shock following an adverse drug reaction to obinutuzumab... A diagnosis of PAPVC should be considered when a left sided CVC fails to cross midline and shows high PvO2 but low pressures.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal: Obinutuzumab as Treatment for ANCA-Associated Vasculitis. (Pubmed Central) - Sep 10, 2022
Obinutuzumab appears to be a safe and efficacious therapy for patients with ANCA-associated vasculitis who have had refractory disease or a history of anaphylaxis to rituximab. Prospective studies comparing rituximab to obinutuzumab in ANCA-associated vasculitis patients are warranted.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Jaypirca (pirtobrutinib) / Eli Lilly, Gazyva (obinutuzumab) / Roche, Biogen
New P2 trial: Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-na (clinicaltrials.gov) - Sep 10, 2022
P2, N=60, Not yet recruiting,
- |||||||||| Enrollment closed, Combination therapy: NP40126: A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL (clinicaltrials.gov) - Sep 8, 2022
P1, N=172, Active, not recruiting,
Eligible patients were aged ≥65 years, or. Recruiting --> Active, not recruiting
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Maximizing Outcomes in CLL (ENMCC - 265-268) - Sep 4, 2022 - Abstract #ASH2022ASH_34;
There remains no known effective standard of care and hence clinical trial enrollment is preferred when possible. Novel treatment approaches using combinations of small molecule targeted agents, antibody-based therapy, and/or CAR-T cell therapy appear to be more beneficial than chemoimmunotherapy alone.
- |||||||||| The Use of Surrogate Endpoints in Health Technology Assessments (HTAs) for Chronic Cancers (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1867;
Despite surrogate and extrapolated endpoints being used and accepted by HTA agencies, inconsistencies were observed in the validation of approximated markers. Our research suggests a need for validation of approximated markers to appropriately assess the validity of these outcomes.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Do Changes in Patient-Reported Outcomes Predict Overall Survival in Patients with Diffuse Large B-Cell Lymphoma? (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1479;
The objective of the study was to explore whether changes in PROs could predict OS in patients with diffuse large B-cell lymphoma (DLBCL) newly treated with obinutuzumab/rituximab plus chemotherapy in the GOYA phase III study. Our findings suggest that changes in PROs, measured by the EORTC QLQ-C30 and FACT–Lym LYMS, contain added predictive value for OS in DLBCL.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Cost-Effectiveness of Obinutuzumab Plus Bendamustine and Followed By Obinutuzumab Maintenance Therapy in Chinese Patients with Relapse and Refractory Follicular Lymphoma (Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_1189;
OBJECTIVES: To assess the cost-effectiveness of obinutuzumab plus bendamustine followed by obinutuzumab maintenance therapy (O-B-O) in Chinese patients with relapse and refractory follicular lymphoma (rrFL) from the perspectives of health care payers A decision analytic model was constructed with Markov model to simulate lifetime health benefits and direct medical costs associated with O-B-O and the conventional therapies [bendamustine, rituximab plus bendamustine (BR), rituximab plus lenalidomide and followed by lenalidomide maintenance therapy (R2), rituximab monotherapy, and lenalidomide monotherapy in Chinese patients with rrFL. Using O-B-O to treat patients with rrFL was highly cost-effective when compared to the conventional therapies from the perspectives of health care payers in China.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Price Erosion for Haemato-Oncology Drugs in European Markets (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_711;
By adding indications or populations and increasing volume, prices go down even if the additive population is smaller and has a greater positive effect and might therefore on its own have attracted a higher price. When considering additional indications for a product reimbursed in Europe, modeling price erosion and additional volumes to understand revenue implications is essential.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Isolation and characterization of human anti-CD20 single-chain variable fragment (scFv) from a Naive human scFv library. (Pubmed Central) - Aug 31, 2022
Afterward, G7 scFv and CD20 were applied to in-silico docking using ClusPro to illustrate the interaction of G7 with the large loop of CD20. As the selected scFv from the human antibody library is devoid of interspecies immunogenic amino acids sequences, no humanization or any other modifications are required prior to clinical applications.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Enrollment open, Trial initiation date, Combination therapy: Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Aug 31, 2022
P2, N=52, Recruiting,
As the selected scFv from the human antibody library is devoid of interspecies immunogenic amino acids sequences, no humanization or any other modifications are required prior to clinical applications. Not yet recruiting --> Recruiting | Initiation date: Jun 2022 --> Oct 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Enrollment change: Obinutuzumab in Primary FSGS (clinicaltrials.gov) - Aug 29, 2022
P2, N=20, Recruiting,
Not yet recruiting --> Recruiting | Initiation date: Jun 2022 --> Oct 2022 N=12 --> 20
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Retrospective data, Journal, HEOR, Real-world evidence: Clinical and economic burden of tumor lysis syndrome among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma: A real-world US retrospective study. (Pubmed Central) - Aug 27, 2022
This study was funded by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design; data collection, analysis, and interpretation; manuscript writing; and the decision to publish the article.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Trial primary completion date: Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Aug 22, 2022
P2, N=81, Active, not recruiting,
No abstract available Trial completion date: Mar 2022 --> Mar 2023 | Trial primary completion date: Mar 2022 --> Mar 2023
- |||||||||| Leukeran (chlorambucil) / GSK, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Video: 5-year follow-up data from the Elevate #CLL TN trial shows that "at 5 years, the acalabrutinib arms continue to demonstrate a progression-free survival benefit vs obinutuzumab plus chlorambucil," said @jeff_sharman, MD, of @WVCancer, in an @OncLive video. https://t.co/yFFmgl0PiC (Twitter) - Aug 17, 2022
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Obinutuzumab in the treatment of B-cell malignancies: a comprehensive review. (Pubmed Central) - Aug 6, 2022
Ongoing research is focusing on the use of biomarkers and the development of chemotherapy-free regimens involving obinutuzumab. phase II trials of such treatment regimens have shown promise for CLL, FL and mantle cell lymphoma, while phase III trials have highlighted obinutuzumab as the antibody partner of choice for novel agents in first-line CLL treatment.
|
