CD79b-targeted antibody-drug conjugate 
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  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche
    The Predictive Value of Cell-of-Origin Subtype By Hans Algorithm in 718 Patients with Large B Cell Lymphoma Receiving Polatuzumab Vedotin (Marriott Grand Ballroom 8-9 (Marriott Marquis San Diego Marina)) -  Nov 6, 2024 - Abstract #ASH2024ASH_1433;    
    This aligns with the cumulative existing evidence. ORR and CRR to pola-containing therapy in the frontline setting did not differ significantly by COO subtype, but longer follow-up of larger cohorts is needed to clarify the predictive role of COO by Hans algorithm in this setting, especially considering the PFS advantage with polaRCHP in POLARIX was not associated with significant differences in ORR or CRR.
  • ||||||||||  Review, Journal:  The Evolving Role of Bispecific Antibodies in Diffuse Large B-Cell Lymphoma. (Pubmed Central) -  Jul 27, 2024   
    Combination strategies with chemotherapy, immunotherapy, and ADCs are currently under investigation with encouraging results in first-line or subsequent lines of treatment. In the following review, we focus on the structure of BsAbs, the mechanism of action, clinical efficacy, and the mechanisms of resistance to BsAbs.
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche
    Post-translational modifications regulate sensitivity to Polatuzumab Vedotin in DLBCL (Section 21; Poster Board #8) -  Mar 14, 2023 - Abstract #AACR2023AACR_8302;    
    Importantly, KLHL6 is heavily mutated across all germinal center derived malignancies, is more highly expressed in germinal center B-cells than other members of the B-cell lineage, and plays an unknown role in the development of autoimmune diseases. Further work will give evidence for the target of KLHL6 mediated ubiquitination and will show how this gene can drive lymphoma and autoimmune disease development in the germinal center.
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche
    Therapeutic potential of polatuzumab vedotin for the treatment of diffuse large B-cell lymphoma (Section 6; Poster Board #11) -  Mar 14, 2023 - Abstract #AACR2023AACR_7732;    
    To further investigate the molecular parameters of the relative sensitivity of polatuzumab vedotin. Gene expression profiling of those PDX models and their sensitivity to polatuzumab vedotin were conducted, we found that the expression level of BCL-XL was correlated with reduced sensitivity to polatuzumab vedotin.
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche
    A CD79b Targeting ADC with Superior Anti-Tumor Activity and Safety Resulting in Significantly Improved Therapeutic Index (TI): Safe and Efficacious CD79b ADC () -  Nov 29, 2022 - Abstract #ASH2022ASH_7180;    
    Therefore, the tolerability in rodents and non-human primates is at least 3 and 8 times higher when compared to historical safety data of Polivy®. Using the HNSTD derived from repeat dose non-human primate toxicity study (24 mg/kg) and the MED calculated from single dose rodent efficacy studies (1 mg/kg) an impressive TI of 24 can be calculated for ARC-02 which is substantially higher than the TI of Polivy®.These encouraging results obtained so far indicate that ARC-02 a) has very favorable biophysical properties, b) shows a consistent and highly defined DAR, c) is highly stable in vitro and in vivo, d) is highly potent and efficacious in multiple tumor models and e) has improved tolerability in rodents and non-human primates and f) shows an impressive improvement in TI and ultimately warrant further development of ARC-02.
  • ||||||||||  Polivy (polatuzumab vedotin-piiq) / Roche
    Cost-Effectiveness Analysis of Frontline Treatment with Polatuzumab Vedotin in Diffuse Large B-Cell Lymphoma (Hall D (Ernest N. Morial Convention Center)) -  Nov 4, 2022 - Abstract #ASH2022ASH_6696;    
    P3
    However, several noticeable factors that could affect the cost-effectiveness profile of pola-R-CHP therapy should be considered in decision-making. The follow-up period of the POLARIX trial was relatively short, and mature survival data would be required to fully evaluate the value of pola in the treatment of newly diagnosed DLBCL.
  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Has R-CHOP Really Been Replaced as Initial Therapy of Diffuse Large B-cell Lymphoma (DLBCL)? () -  Sep 22, 2022 - Abstract #SOHO2022SOHO_389;    
    Despite this massive increase in biologic understanding, the standard of care for most patients has been rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (RCHOP) for more than 20 years...More recently, a series of studies leveraging cell of origin status, attempting a “precision approach” to DLBCL have evaluated the addition of drugs like bortezomib (targeting NF kappa B), ibrutinib (targeting Brutons tyrosine kinase), and lenalidomide (targeting cereblon) to RCHOP for patients with ABC subtype of DLBCL...It is disappointing that RCHP-polatuzumab is a subtype-agnostic treatment, not informed by our improved understanding of the heterogeneity of DLBCL. However, taken together, RCHPpolatuzumab will likely replace RCHOP as preferred upfront treatment in intermediate and high clinical risk subsets of DLBCL, at least until future precision medicine approaches utilizing mutation-defi ned subsets of DLBCL are developed.2
  • ||||||||||  Review, Journal, IO biomarker:  Follicular lymphoma: The long and winding road leading to your cure? (Pubmed Central) -  Aug 3, 2022   
    The most exciting data currently involve immune attack against follicular lymphoma by chimeric antigen receptor T-cells (CART) or bispecific antibody constructs. Given these multiple potentially non-crossreactive mechanisms, studies of rationally designed combination strategies hold the promise of improving outcomes and possibly cure of follicular lymphoma.
  • ||||||||||  Polivy (polatuzumab vedotin) / Roche
    A CD79b Targeting ADC with Superior Anti-Tumor Activity and Tolerability (Ballroom A) -  Apr 24, 2022 - Abstract #PEGS2022PEGS_411;    
    We developed a very stable anti-CD79b-MMAE ADC with this technology showing a 4-6-fold higher therapeutic index compared to polatuzumab-vedotin in preclinical models. Our ADC may represent a safe and efficacious alternative for the treatment of patients with diffuse-large B-cell lymphoma (DLBCL).
  • ||||||||||  Polivy (polatuzumab vedotin) / Roche
    A CD79b targeting ADC with superior anti-tumor activity and therapeutic index (Section 38) -  Mar 9, 2022 - Abstract #AACR2022AACR_4839;    
    We developed a very stable anti-CD79b-MMAE ADC with this technology showing a higher therapeutic index compared to polatuzumab-vedotin in preclinical models...Finally, the highest non-severely toxic dose (HNSTD) of ARADC was determined at 30mg/kg in a 4-week repeat dose toxicology study in rats. This observation, together with the high anti-tumor potency at low dose - the minimal effective dose (MED), results in an overall 4-6-fold increased therapeutic index (TI).These encouraging results obtained so far indicate that ARADC a) has very favorable biophysical properties, b) shows a clearly defined drug-to-antibody ratio, c) is highly stable in vitro and in vivo, d) is highly potent and efficacious in multiple tumor models and e) showed an improvement in TI by a factor of 4-6 and ultimately warrant further development of ARADC.
  • ||||||||||  Polivy (polatuzumab vedotin) / Roche
    Journal:  Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. (Pubmed Central) -  Feb 2, 2022   
    P3
    Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was lower among those who received pola-R-CHP than among those who received R-CHOP. (Funded by F. Hoffmann-La Roche/Genentech; POLARIX ClinicalTrials.gov number, NCT03274492.).
  • ||||||||||  Polivy (polatuzumab vedotin) / Roche
    Preclinical Evidence for the Efficacy of CD79b Immunotherapy in B Cell Precursor Acute Lymphoblastic Leukemia (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_4014;    
    Accordingly, the CD79b antibody drug conjugate (ADC) Polatuzumab Vedotin (PolVed) has shown therapeutic efficacy in the treatment of refractory/relapsed (r/r) diffuse large B cell lymphoma...Therefore, we suggest CD79b as a novel therapeutic target in BCP-ALL and propose PolVed as a potential therapeutic agent in r/r disease. *LL and DW contributed equally to this work
  • ||||||||||  Revlimid (lenalidomide) / BMS
    [VIRTUAL] Innovative Approaches in Untreated DLBCL () -  May 20, 2021 - Abstract #SOHO2021SOHO_253;    
    Introduction Diffuse large B-cell lymphoma (DLBCL), the most common lymphoid cancer, is curable but has been treated with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)-based chemotherapy for decades.1 DLBCL is a heterogeneous disease with distinct subtypes with differential responses to targeted therapy; however, this has not yet translated into standard therapy.2,3 Most frontline DLBCL trials employ an R-CHOP versus R-CHOP + X chemotherapy, which assumes X will either add to or synergize with chemotherapy and not antagonize or have significant added toxicity with chemotherapy.4 Notable examples include lenalidomide, ibrutinib, venetoclax, and bortezomib, among others...The initial trial cohort (N=30) will receive four cycles of lenalidomide (25 mg days 1–10 of a 21-day cycle), tafasitamab (12 mg/kg weekly), rituximab (375 mg/m2 day 1), and acalabrutinib (100 mg twice daily) (uLRTA), with serial ctDNA monitoring...The GO40515 trial evaluated mosunetuzumab in combination with CHOP or CHP-polatuzumab (see below).8 This trial, to date, has included 36 patients with de novo DLBCL, median age 66 years, and median IPiof 3...Loncastuximab tesirine, an antibody–drug conjugate targeting CD19, was found to have an ORR of 42% in relapsed DLBCL,9 and the naked CD19 antibody tafasitamab in combination with lenalidomide demonstrated an ORR of 43% in this population.10 Both are approved in the relapsed setting and are promising Figure 1 agents to consider when designing chemotherapy-free approaches targeting elderly and unfit patients...The ongoing phase IIiPOLARIX trial compares R-CHP-polatuzumab with R-CHOP in de novo DLBCL, with highly anticipated results...Patients with high-risk DLBCL (N=31) and a positive interim PET scan after two cycles of chemo-immunotherapy received axicabtagene ciloleucel, currently approved after two lines of therapy.13 Median age was 60-years, 67% had poor-risk IPI, and 60% had DHL...These include targeted agents, antibody–drug conjugates, bispecific T-cell engagers, and cellular therapies, such as CAR-T. Applying these agents while utilizing a deeper understanding of DLBCL biology, coupled with more accurate real-time assessment with ctDNA, may prove to be the necessary ingredients to establish a new standard of care for frontline DLBCL.