- |||||||||| Journal: Antibodies to watch in 2023. (Pubmed Central) - Dec 7, 2022
As of mid-November, 12 antibody therapeutics had been granted first approvals in either the United States or European Union (tebentafusp (Kimmtrak), faricimab (Vabysmo), sutimlimab (Enjaymo), relatlimab (Opdualag), tixagevimab/cilgavimab (Evusheld), mosunetuzumab (Lunsumio), teclistamab (TECVAYLI), spesolimab (SPEVIGO), tremelimumab (Imjudo; combo with durvalumab), nirsevimab (Beyfortus), mirvetuximab soravtansine (ELAHERE™), and teplizumab (TZIELD)), including 4 bispecific antibodies and 1 ADC...An additional seven were first approved in China or Japan in 2022, including two bispecific antibodies (cadonilimab and ozoralizumab)...Our data show that, with antibodies for COVID-19 excluded, the late-stage commercial clinical pipeline grew by ~20% in the past year to include nearly 140 investigational antibody therapeutics that were designed using a wide variety of formats and engineering techniques. Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine).
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Lunsumio (mosunetuzumab-axgb) / Roche
Trial primary completion date: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov) - Nov 23, 2022 P1, N=56, Recruiting, Of those in late-stage development, marketing application submissions for at least 23 may occur by the end of 2023, of which 5 are bispecific (odronextamab, erfonrilimab, linvoseltamab, zanidatamab, and talquetamab) and 2 are ADCs (datopotamab deruxtecan, and tusamitamab ravtansine). Trial primary completion date: Apr 2024 --> Dec 2023
- |||||||||| Brukinsa (zanubrutinib) / BeiGene, Lunsumio (mosunetuzumab) / Roche, Biogen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Top advances in lymphoma for 2021. (Pubmed Central) - Nov 19, 2022 On the basis of these trends, PI3K inhibitors are being displaced in favor of safer and more durable constructs. In addition, within the past year, the approval and implementation of zanubrutinib for marginal zone lymphoma have filled a need for later line therapy, especially for less fit and elderly patients.
- |||||||||| Lunsumio (mosunetuzumab-axgb) / Roche
Trial completion date, Trial initiation date, Trial primary completion date: Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma (clinicaltrials.gov) - Nov 9, 2022 P1, N=15, Not yet recruiting, In addition, within the past year, the approval and implementation of zanubrutinib for marginal zone lymphoma have filled a need for later line therapy, especially for less fit and elderly patients. Trial completion date: Mar 2027 --> Jun 2027 | Initiation date: Sep 2022 --> Dec 2022 | Trial primary completion date: Apr 2025 --> Jul 2025
- |||||||||| Lunsumio (mosunetuzumab) / Roche, Biogen
Mosunetuzumab with Lenalidomide Augmentation As First-Line Therapy for Follicular (FL) and Marginal Zone Lymphoma (MZL) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_3224; P2 Correlative studies aim at determining predictive biomarkers of response to first-line mosunetuzumab therapy (± lenalidomide augmentation), which include immune signatures based on circulating T-cell and macrophage subsets and serum cytokines. The investigators will further analyze changes in the circulating tumor DNA (ctDNA) during first-line immunotherapy with mosunetuzumab in this setting.
- |||||||||| Polivy (polatuzumab vedotin-piiq) / Roche, Lunsumio (mosunetuzumab) / Roche, Biogen
Mosunetuzumab with Polatuzumab Vedotin Is Effective and Has a Manageable Safety Profile in Patients Aged <65 and ≥65 Years with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) and ≥1 Prior Therapy: Subgroup Analysis of a Phase Ib/II Study (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_2485; P1/2 At study entry, for pts aged ≥65 years, the median age was 73 years (range: 65–83), 53% had ECOG PS 1 and 8% had PS 2, 50% had International Prognostic Index 3–5, 81% had Ann Arbor stage III/IV disease, and 81% and 72% were refractory to a prior anti-CD20 Ab and to last prior therapy, respectively. There were more pts <65 years than pts ≥65 years with high lactate dehydrogenase (LDH; 63% vs 44%, respectively), with ≥3 prior lines of therapy (67% vs 56%), and refractory to CAR T-cell therapy (38% vs 25%; Table).
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