- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Enrollment open, Trial completion date, Trial primary completion date: Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients with Relapsed or Refractory Grade 1-3a Follicular Lymphoma (clinicaltrials.gov) - Aug 14, 2024 P2, N=41, Recruiting, Findings from this study show improved efficacy and more durable response for the treatment of 3L+ R/R FL with axi-cel relative to mosunetuzumab, with increased odds of all-grade CRS and NE, but not G3+ CRS and TRAEs. Not yet recruiting --> Recruiting | Trial completion date: Mar 2027 --> Mar 2028 | Trial primary completion date: Mar 2027 --> Mar 2028
- |||||||||| Approach to Untreated Follicular Lymphoma, Where Are We Now and Future Directions (LEVEL 3, GENERAL ASSEMBLY) - Jul 5, 2024 - Abstract #SOHO2024SOHO_228;
Not yet recruiting --> Recruiting In both the StiL and BRIGHT trials, a head-to-head comparison of R-CHOP vs. bendamustine + rituximab (BR) demonstrated superior outcomes with BR with a lower toxicity than R-CHOP.2,3 Attempts to improve on bendamustine-containing chemotherapy with the second-generation monoclonal antibody obinutuzumab, as tested in the GALLIUM trial, improved complete remission rates but resulted in fairly significant myelosuppression and a higher incidence of infection...5 In terms of
- |||||||||| Novel Approaches to Richter Syndrome (LEVEL 3, GENERAL ASSEMBLY) - Jul 5, 2024 - Abstract #SOHO2024SOHO_193;
P1/2, P2 Trials are also ongoing with bispecific antibodies, such as the CD20-directed CD3 T-cell engagers, epcoritamab (NCT04623541),14 glofitamab (NCT06043674), and mosunetuzumab (NCT05207670),15 which, like CAR-T therapy, have all shown efficacy in standard DLBCL. As evidenced, significant efforts employing a multifaceted array of approaches are underway for the treatment of RS, generating hope for the possibility of improved outcomes for this aggressive disease.
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche, Biogen, Yescarta (axicabtagene ciloleucel) / Gilead
Clinical, Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of treating relapsed or refractory 3L+ follicular lymphoma with axicabtagene ciloleucel vs mosunetuzumab in the United States. (Pubmed Central) - Jun 10, 2024 Scenarios one and two resulted in ICERs of $105,353 and $102,695, respectively. This study finds that axi-cel is cost-effective compared to mosun at the commonly cited $150,000/QALY US willingness-to-pay threshold, with robust results across a range of sensitivity analyses accounting for parameter uncertainty.
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion date, Trial primary completion date: Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - Jun 3, 2024 P1, N=30, Recruiting, This study finds that axi-cel is cost-effective compared to mosun at the commonly cited $150,000/QALY US willingness-to-pay threshold, with robust results across a range of sensitivity analyses accounting for parameter uncertainty. Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
- |||||||||| Review, Journal: The value of bispecific antibodies in relapsed and refractory DLBCL. (Pubmed Central) - May 30, 2024
This review discusses the background clinical need, mechanism of action, and clinical data including efficacy and toxicity for bispecific antibodies in DLBCL, focusing on the most advanced class in development; CD20 targeting T-cell engaging antibodies. Emerging possibilities for future use of bispecific antibodies is also discussed, including novel and cytotoxic combination regimens in relapsed and first-line settings.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, odronextamab (REGN1979) / Regeneron, Lunsumio (mosunetuzumab-axgb) / Roche, Biogen
Review, Journal: Bispecific antibodies in the treatment of Relapsed/Refractory large B-cell lymphoma. (Pubmed Central) - May 29, 2024 These drugs provide a highly efficacious and relatively safe treatment option for patients with highly pre-treated disease including relapse after cellular immunotherapies. In addition, these BsAbs provide a platform for chemotherapy-free regimen for older/frail patients.
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche
Trial primary completion date: CO41942: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (clinicaltrials.gov) - May 28, 2024 P1/2, N=187, Active, not recruiting, PopPK model simulations, investigating Mosun dose delays, informed treatment resumption protocols to ensure CRS mitigation. Trial primary completion date: Feb 2024 --> Nov 2025
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche
Trial primary completion date: CO41942: A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (clinicaltrials.gov) - Apr 16, 2024 P1/2, N=187, Active, not recruiting, Over 3 years, the estimated cumulative per patient cost of mosunetuzumab is lower than most available newer therapies, resulting in a small increase in the budget after its formulary adoption for the treatment of relapsed or refractory follicular lymphoma. Trial primary completion date: Nov 2027 --> Feb 2024
- |||||||||| Journal: A pivotal decade for bispecific antibodies? (Pubmed Central) - Mar 15, 2024
Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.
- |||||||||| Columvi (glofitamab-gxbm) / Roche, Lunsumio (mosunetuzumab-axgb) / Roche, Biogen, Zynlonta (loncastuximab tesirine-lpyl) / Overland ADCT BioPharma
Quantitative systems pharmacology modeling of loncastuximab tesirine combined with mosunetuzumab and glofitamab helps guide dosing for patients with DLBCL (Section 36) - Mar 5, 2024 - Abstract #AACR2024AACR_2209; P1 Increased doses of Lonca in combinations were predicted to have limited additional therapeutic benefit; however, additional cycles of combination treatment were predicted to increase TGI. This model suggests that Lonca doses could be reduced to allow for improved tolerability for longer periods of time, up to the point of maximal benefit, although clinical testing is needed to explore these results.
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche, tiragolumab (RG6058) / Roche, Tecentriq (atezolizumab) / Roche
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab in Combination With Tiragolumab With or Without Atezolizumab in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - Mar 3, 2024 P1/2, N=8, Completed, This model suggests that Lonca doses could be reduced to allow for improved tolerability for longer periods of time, up to the point of maximal benefit, although clinical testing is needed to explore these results. Active, not recruiting --> Completed | N=118 --> 8 | Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Dec 2023 --> Jul 2023
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