- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Journal, Real-world evidence, Real-world: Real-world time to discontinuation of first-line venetoclax?+?obinutuzumab in chronic lymphocytic leukemia/small lymphocytic lymphoma. (Pubmed Central) - Sep 7, 2023 Additionally, treatment utilization, including medications related to TLS mitigation and management, was more intense during the initiation phase of VO. Further research with longer follow-up to assess long-term outcomes of VO treatment after early discontinuation is warranted.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
The Case for Extending Treatment in MRD+ Patients on Venetoclax + Obinutuzumab Therapy () - Aug 31, 2023 - Abstract #SOHO2023SOHO_952; When utilizing an MRD monitoring strategy for informed clinical decision making for patients with this regimen, we believe that the presently available data suggests a favorable benefit/risk profile for venetoclax continuation for MRD+ patients, with particularly strong rationale for therapy continuation in the highest-risk patient populations (TP53 aberrancy). We remain hopeful that as further randomized data becomes available, the best course of action for the management of MRD+ patients will be better defined.
- |||||||||| Is Fixed-Duration Therapy the New Standard of Care in Frontline CLL? () - Aug 31, 2023 - Abstract #SOHO2023SOHO_951;
An improved understanding of the disease biology has contributed to the development of novel agents able to target key pathways in CLL.2 Two classes of targeted agents have been extremely impactful in shaping current treatment of CLL: the BCL2 inhibitor venetoclax and the Bruton's tyrosine kinase inhibitors (BTKi) ibrutinib, acalabrutinib and zanubrutinib...Patients received six 28-day cycles of ibrutinib in combination with fludarabine, cyclophosphamide and rituximab (FCR) followed by 2 years of ibrutinib maintenance...The combination of ibrutinib-venetoclax demonstrated superior progression-free survival (24 months estimated rate 84.4% for patients treated with ibrutinib-venetoclax and 44.1% for patients treated with chlorambucil-obinutuzumab) and superior rates of U-MRD (55.7% vs 21%).15 The time-limited approach with concomitant administration of BTK and BCL2 targeting agents has potential advantages over continuous BTK inhibitor-based therapy in terms of reduced risk for treatment-related side effects due to the prolonged administration and potentially lower costs8 , however, there are still open questions in terms of selection of therapy at time of retreatment and quality and durability of responses to subsequent therapies. It is important to note that treatment with combination of BTKi and venetoclax with or without CD20 monoclonal antibodies is not FDA approved and is still being investigated in clinical trials.
- |||||||||| Covalent Inhibitors of BTK in the Treatment of CLL () - Aug 31, 2023 - Abstract #SOHO2023SOHO_940;
In the frontline setting, the ELEVATE-TN study compared acalabrutinib, either alone or in combination with obinutuzumab, to chlorambucil plus obinutuzumab...Frontline phase 3 trial data comes from the SEQUOIA study, where zanubrutinib was compared with bendamustine plus rituximab...The combination of ibrutinib plus venetoclax has received frontline approval from the EMA. Ongoing studies may offer future options of time-limited therapy involving covalent BTK, but current approaches with indefinite covalent BTK treatment offer a safe and effective strategy to treat CLL patients at this time.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Lenalidomide (ViPOR) in Relapsed/Refractory (R/R) and Treatment?Na () - Aug 31, 2023 - Abstract #SOHO2023SOHO_933; Fixed- duration ViPOR induces a high rate of MRD-negative CRs in MCL, including high-risk patients. ViPOR with a 12d venetoclax ramp-up on C2 is safe in MCL patients of all ages.
- |||||||||| Journal, HEOR, Real-world evidence, Real-world: Real-World Evidence on the Clinical Characteristics and Management of Patients with Chronic Lymphocytic Leukemia in Spain Using Natural Language Processing: The SRealCLL Study. (Pubmed Central) - Aug 26, 2023
The most common antineoplastic treatment was ibrutinib in 1L (64.8%) and 2L (62.1%), followed by bendamustine + rituximab (12.6%), obinutuzumab + chlorambucil (5.2%), rituximab + chlorambucil (4.8%), and idelalisib + rituximab (3.9%) in 1L and venetoclax (15.5%), idelalisib + rituximab (6.9%), bendamustine + rituximab (3.5%), and venetoclax + rituximab (3.5%) in 2L. This study expands the information available on patients with CLL in Spain, describing the diversity in patient characteristics and therapeutic approaches in clinical practice.
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen
Trial primary completion date: OLYMP-1: Obinutuzumab in Marginal Zone Lymphoma (clinicaltrials.gov) - Aug 24, 2023 P2, N=56, Active, not recruiting, This study expands the information available on patients with CLL in Spain, describing the diversity in patient characteristics and therapeutic approaches in clinical practice. Trial primary completion date: Jun 2023 --> Jun 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Imbruvica (ibrutinib) / AbbVie, J&J
Trial completion date, Combination therapy: A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Aug 23, 2023 P1, N=54, Active, not recruiting, Trial completion date: Jul 2023 --> Jul 2026 | Trial primary completion date: Jul 2023 --> Jul 2026 Trial completion date: Jul 2023 --> Jan 2029
- |||||||||| Trial completion date, Trial primary completion date, 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) - Aug 21, 2023
P1, N=172, Active, not recruiting, Trial completion date: Jun 2028 --> May 2027 Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024
- |||||||||| Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Trial completion date, Trial primary completion date, Combination therapy, Minimal residual disease: A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL (clinicaltrials.gov) - Aug 18, 2023 P2, N=55, Active, not recruiting, Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Oct 2024 Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Imbruvica (ibrutinib) / AbbVie, J&J
Enrollment closed, Adverse events, Combination therapy: Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (clinicaltrials.gov) - Aug 15, 2023 P2, N=20, Active, not recruiting, Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025 Recruiting --> Active, not recruiting
- |||||||||| Anyara (naptumomab estafenatox) / NeoTX
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Checkpoint inhibition, Metastases: NT-NAP-102-1: Naptumomab Estafenatox (NAP) in Combination With Docetaxel Following Obinutuzumab Pretreatment in Subjects With Checkpoint Inhibitor Pretreated Advanced or Metastatic NSCLC (clinicaltrials.gov) - Aug 15, 2023 P2a, N=38, Active, not recruiting, Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Oct 2023 --> Jan 2024
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Clinical outcomes in patients with chronic lymphocytic leukemia (CLL) treated with venetoclax-based regimens (Hynes Convention Center Meeting Room 302/304. Level 3 900 Boylston St., Boston, MA) - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_301; Patients with BTKi-exposed CLL, particularly those with prior disease progression on BTKi, had worse outcomes. Our study identified CK as one of the most important baseline predictors of adverse TFS and OS in the overall cohort of patients, supporting karyotype assessment for prognostication prior to venetoclax treatment.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Venetoclax-Obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized CLL14 study () - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_222; Five years after cessation of Ven-Obi, over half of the patients of this elderly patient population remained in remission, 8% still had uMRD and over 60% had not required second-line treatment. The 1-year Ven-Obi regimen is an effective fixed-duration option for patients with CLL and coexisting conditions.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku
Long-term follow-up of multicenter phase II trial of zanubrutinib, obinutuzumab, and venetoclax (BOVen) in previously untreated patients with chronic lymphocytic leukemia: Impact of early MRD kinetics on posttreatment outcomes () - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_210; P2 Long-term follow up of BOVen demonstrate high rates of durable uMRD-FC. A phase II trial of BOVen with ?MRD400-directed treatment duration is planned, and we hypothesize that longer duration of therapy for pts who fail ?MRD400 (24 vs. 10 mo) will further improve uMRD duration in these pts.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Venetoclax Consolidation after BTKi Based Therapy for Patients with CLL () - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_173; There has been increasing focus on investigating the combination BTKi and ven. However, combination therapy does increase the risk of hematologic and gastrointestinal side effects, which can lead to dose reduction or drug discontinuation [3].
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute
Real-World Duration of Venetoclax Treatment for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma () - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_166; For patients treated for less than the fixed-dosing schedules, the mean DoT was <5 months in those treated with V + O and <7 months in those treated with V + R. Patients treated beyond the fixed-dosing schedules continued treatment for approximately 3 more months with V + O and 6 more months with V + R. This study provides evidence that a V-based approach may not be suitable for all patients with CLL/SLL. Future studies should include additional follow-up with a larger sample, reasons for treatment discontinuation, and patient molecular genetic profile.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Gazyva (obinutuzumab) / Roche, Biogen, Nippon Shinyaku, Calquence (acalabrutinib) / AstraZeneca
Bendamustine, Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients (Pts) with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL): Updated Results of the CLL2-BAAG Trial of the German CLL Study Group (GCLLSG) (Hynes Convention Center Exhibit Hall D, Level 2 900 Boylston St., Boston, MA) - Aug 14, 2023 - Abstract #IWCLL2023IWCLL_122; Randomized trials will define if the triple combination of a BTK inhibitor, a BCL2 inhibitor and a CD20 antibody is superior to combinations of two of these agents. Until then, the use of this triple combination in routine practice cannot be recommended.
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