- |||||||||| Scemblix (asciminib) / Novartis
Journal: Asciminib Maintains Antibody-Dependent Cellular Cytotoxicity against Leukemic Blasts. (Pubmed Central) - Apr 13, 2024
P1/2, P2
Other monoclonal antibodies, such as tafasitamab (anti-CD19), obinutuzumab (anti-CD20) and epratuzumab (anti-CD22) have been tested in trials (NCT05366218, NCT04920968, NCT00098839)...In contrast to ATP site inhibitors such as dasatinib and ponatinib, the novel first-in-class selective allosteric ABL myristoyl pocket (STAMP) inhibitor asciminib did not significantly impact ADCC in our settings. Our results suggest that asciminib should be considered in clinical trials.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Imbruvica (ibrutinib) / AbbVie, J&J
Trial primary completion date: Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System (clinicaltrials.gov) - Apr 12, 2024
P1, N=12, Recruiting,
Our results suggest that asciminib should be considered in clinical trials. Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Anyara (naptumomab estafenatox) / NeoTX, Gazyva (obinutuzumab) / Roche, Biogen
Enrollment change, Trial initiation date, Trial withdrawal, Trial primary completion date, Combination therapy: Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers (clinicaltrials.gov) - Apr 12, 2024
P1, N=0, Withdrawn,
Trial primary completion date: Mar 2024 --> Mar 2025 N=30 --> 0 | Initiation date: Jun 2023 --> Nov 2023 | Not yet recruiting --> Withdrawn | Trial primary completion date: Aug 2024 --> Dec 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: Obinutuzumab, Venetoclax, and Lenalidomide in Treating Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Apr 8, 2024
P1, N=22, Active, not recruiting,
Conversely, 38% of pts on 1L BTKi discontinued their index treatment at a median of 3.6 months, and nearly 40% of these pts initiated another CLL treatment. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial initiation date: Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov) - Apr 7, 2024
P2, N=40, Not yet recruiting,
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Initiation date: Mar 2024 --> Jun 2024
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Polivy (polatuzumab vedotin-piiq) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial initiation date, Trial primary completion date, CAR T-Cell Therapy: PORTAL: A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab as a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma (clinicaltrials.gov) - Apr 4, 2024
P2, N=99, Not yet recruiting,
No abstract available Trial completion date: Jan 2028 --> Jul 2028 | Initiation date: Jan 2024 --> Apr 2024 | Trial primary completion date: Jan 2028 --> Jan 2027
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Review, Journal: Disseminated Enterovirus Infection in a Patient Affected by Follicular Lymphoma Treated with Obinutuzumab: A Case Report and a Narrative Review of the Literature. (Pubmed Central) - Apr 1, 2024
The most common signs and clinical presentations of EV infection were fever and encephalitis symptoms (N = 6, 85.7%), followed by hepatitis/acute liver failure (N = 5, 71.4%). onco-hematological patients who receive immune-chemotherapy with a combination of treatments which depress adaptative immunity, which includes the antiCD20 obinutuzumab, could be at higher risk of disseminated EV infection, including CNS and cardiac involvement.
- |||||||||| AlloNK (AB-101) / GC Biopharma
Potent and specific killing of SLE donor B Cells with AlloNK (Exhibit Hall F1; Poster Board Number: B845) - Mar 29, 2024 - Abstract #IMMUNOLOGY2024IMMUNOLOGY_1433;
Killing was specific as no off-target apoptosis of T cells was observed. Taken together, these data suggest that AlloNK has the potential to be effective in combination with mAbs to induce deeper B cell depletion and improved efficacy, over the mAbs alone, in SLE.
- |||||||||| Epkinly (epcoritamab-bysp) / Genmab, AbbVie
Trial completion date, Adverse events, Combination therapy: EPCORE (clinicaltrials.gov) - Mar 25, 2024
P3, N=900, Recruiting,
Obinutuzumab is currently undergoing further evaluation in patients with active proliferative LN in the global, registrational, Phase III REGENCY trial (NCT04221477). Trial completion date: Sep 2037 --> May 2037
- |||||||||| Journal: Emerging biologic therapies for systemic lupus erythematosus. (Pubmed Central) - Mar 25, 2024
Trial completion date: Sep 2037 --> May 2037 While many drug candidates which met the end points in phase II trials have failed phase III trials, the number of target-specific therapies for SLE has continued to expand.
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche, Biogen, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial completion date, Trial primary completion date: NCI-2021-12489: Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Mar 22, 2024
P2, N=42, Recruiting,
Our study suggests that changes in some PROs are related to survival in DLBCL patients. Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Itari (linperlisib) / Shanghai YingLi Pharma
New P2 trial, Combination therapy: Linperlisib Plus Obinutuzumab and Venetoclax for Relapsed and Refractory Blastoid Variant of Mantle Cell Lymphoma. (clinicaltrials.gov) - Mar 22, 2024
P2, N=10, Not yet recruiting,
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Journal, CAR T-Cell Therapy, Real-world evidence, Real-world: Optimizing Real-World Outcomes in High-Risk Relapsed/Refractory (r/r) FL with CAR-T Cell Therapy: A Vodcast and Case Example. (Pubmed Central) - Mar 21, 2024
Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025 The patient received eight cycles of rituximab-cyclophosphamide-doxorubicin-vincristine-prednisolone (R-CHOP), followed by irradiation and rituximab maintenance (first-line) and then received rituximab 4?
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Trial primary completion date: Bendamustine, Obinutuzumab, and Venetoclax in Patients With Untreated Mantle Cell Lymphoma (clinicaltrials.gov) - Mar 21, 2024
P2, N=23, Active, not recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| cibisatamab (RG7802) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Tecentriq (atezolizumab) / Roche
Trial completion, Combination therapy, Metastases: A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov) - Mar 14, 2024
P1, N=47, Completed,
Mean age at diagnosis was 11 years (SD 5 years). Active, not recruiting --> Completed
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie
Review, Journal, IO biomarker: Venetoclax Initiation in Chronic Lymphocytic Leukemia: International Insights and Innovative Approaches for Optimal Patient Care. (Pubmed Central) - Mar 13, 2024
In addition to summarizing the evidence for venetoclax's efficacy and safety, this review uses hypothetical patient scenarios based on risk level for TLS (high, medium, low) to share the authors' clinical experience with venetoclax initiation and present global approaches utilized in various treatment settings. These hypothetical scenarios highlight the importance of a multidisciplinary approach and shared decision-making, outlining best practices for venetoclax initiation and overall optimal treatment strategies in patients with CLL.
- |||||||||| Calquence (acalabrutinib) / AstraZeneca
Enrollment closed, Combination therapy, IO biomarker: ACE-CL-311: Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL (clinicaltrials.gov) - Mar 13, 2024
P3, N=984, Active, not recruiting,
These hypothetical scenarios highlight the importance of a multidisciplinary approach and shared decision-making, outlining best practices for venetoclax initiation and overall optimal treatment strategies in patients with CLL. Recruiting --> Active, not recruiting
- |||||||||| cibisatamab (RG7802) / Roche, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, RG7827 / Roche
Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov) - Mar 12, 2024
P1/2, N=80, Active, not recruiting,
Recruiting --> Active, not recruiting Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Aliqopa (copanlisib) / Bayer
Enrollment closed, Trial primary completion date, 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) - Mar 12, 2024
P2, N=98, Active, not recruiting,
Trial completion date: Jun 2026 --> Jan 2029 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2022 --> Sep 2023
- |||||||||| Journal, Adverse events, Combination therapy, Real-world evidence, Real-world: A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for Bruton's tyrosine kinase inhibitors (BTKis) single and its combination therapy. (Pubmed Central) - Mar 8, 2024
The Reporting Odds Ratio (ROR) was used to analyze the data on three BTKis monotherapies and combinations of ibrutinib with rituximab, obinutuzumab, venetoclax, and lenalidomide in the FDA Adverse Event Reporting System (FAERS) database up to December 2022...In monotherapies, atrial fibrillation (ROR (95% CI): 9.88 (9.47-10.32)) in zanbrutinib and rash (6.97 (5.42-8.98)) in acalabrutinib had higher associations...The Ibrutinib-Obinutuzumab combo has the highest risk of infection, atrial fibrillation and myelosuppression, the Ibrutinib-Lenalidomide combo has the highest risk of pyrexia. However, the Ibrutinib-Venetoclax combo has a lower risk of hemorrhage than monotherapy.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Targeted Literature Review of Cost-Effectiveness Models in Relapsed/Refractory Follicular Lymphoma () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_381;
Long duration of B cell depletion and high immunological remission rate may account for its remarkable efficiency. Treatments in NICE TAs (bendamustine + obinutuzumab [BO]) and CADTH reviews (axicabtagene ciloleucel, tisagenlecleucel, BO) were recommended for R/R FL in the UK and Canada, respectively, with ICERs ranging from
- |||||||||| Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Budget Impact Analysis of Zanubrutinib + Obinutuzumab for the Treatment of Relapsed or Refractory Follicular Lymphoma in the United States () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_287;
Treatments in NICE TAs (bendamustine + obinutuzumab [BO]) and CADTH reviews (axicabtagene ciloleucel, tisagenlecleucel, BO) were recommended for R/R FL in the UK and Canada, respectively, with ICERs ranging from In the payer plan, 19 R/R FL patients were estimated to receive 3L+ treatment with ZO, lenalidomide
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Enrollment closed: ORION: Obinutuzumab in Primary MN (clinicaltrials.gov) - Mar 5, 2024
P2, N=20, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Feb 2025 --> Feb 2024 Recruiting --> Active, not recruiting
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Rituxan (rituximab) / Roche
Novel Fc?R humanized mouse model enables assessment of PK/PD of therapeutic antibodies (Section 4) - Mar 5, 2024 - Abstract #AACR2024AACR_8313;
We are currently investigating the PK profile of therapeutic antibodies in the hFc?R/hSA/hFcRn model. This novel tool is being improved to enable tolerability to human IgG1, biodistribution to the central nervous system, and flexibility of test of therapeutics through expression of human immune checkpoints.
- |||||||||| golcadomide (CC-99282) / BMS
Golcadomide (CC-99282) is a novel CELMoD (Section 27) - Mar 5, 2024 - Abstract #AACR2024AACR_5459;
Ven inhibited this immune activation, while Obi or Ibru maintained the immune activation. Collectively, these findings suggest that GOLCA, alone or in combination with targeted agents, may produce clinical benefit in CLL patients.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date: 17P.176: Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas (clinicaltrials.gov) - Mar 5, 2024
P2, N=30, Recruiting,
Collectively, these findings suggest that GOLCA, alone or in combination with targeted agents, may produce clinical benefit in CLL patients. Trial completion date: Dec 2023 --> Feb 2031
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