Ziihera (zanidatamab-hrii) / Jazz 
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 0 Diseases   10 Trials   10 Trials   233 News 


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  • ||||||||||  zanidatamab (ZW25) / Jazz
    Zanidatamab? (Twitter) -  Jan 20, 2023   
  • ||||||||||  zanidatamab (ZW25) / Jazz
    Zanidatamab + chemotherapy as first-line treatment for HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA). (Available On Demand; Poster Board No. E8) -  Dec 13, 2022 - Abstract #ASCOGI2023ASCO_GI_172;    
    P2, P3
    This maturing data set demonstrates durable disease control with encouraging cORR, DOR, PFS and OS results. A global Ph 3 study (HERIZON-GEA-01; NCT05152147) evaluating zani in combination with physician’s choice of standard chemo with or without the PD-1 inhibitor, tislelizumab, for first-line treatment of advanced HER2+ mGEA is currently enrolling.
  • ||||||||||  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).
  • ||||||||||  zanidatamab (ZW25) / Jazz
    Journal:  Zanidatamab Is Safe and Efficacious in HER2-Expressing/Amplified Cancers. (Pubmed Central) -  Dec 3, 2022   
    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). Zanidatamab is safe with preliminary efficacy in multiple HER2-expressing and HER2-amplified tumors.
  • ||||||||||  Ziihera (zanidatamab-hrii) / Jazz
    Trial completion date, Trial primary completion date, Metastases:  ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov) -  Nov 1, 2022   
    P1,  N=279, Active, not recruiting, 
    Evaluation of zanidatamab continues in ongoing studies. Trial completion date: Oct 2022 --> Aug 2023 | Trial primary completion date: Sep 2022 --> Jun 2023
  • ||||||||||  Baize'an (tislelizumab) / BeiGene, Novartis, zanidatamab (ZW25) / Jazz
    Review, Journal:  HERIZON-GEA-01: Zanidatamab + chemo ± tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. (Pubmed Central) -  Oct 20, 2022   
    Preliminary data suggest that dual targeting of the HER2 and PD-1 pathways could further improve upon the results achieved with targeting either pathway alone. Here, we describe the design of HERIZON-GEA-01, a global, randomized, open-label, active-comparator, Phase III study to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy with or without tislelizumab to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for patients with advanced/metastatic HER2-positive GEAs.
  • ||||||||||  Ziihera (zanidatamab-hrii) / Jazz
    Trial primary completion date, Combination therapy, Metastases:  ZWI-ZW25-202: A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer (clinicaltrials.gov) -  May 3, 2022   
    P2a,  N=86, Recruiting, 
    HERIZON-GEA-01 (NCT05152147; EudraCT#: 2021-000296-36), is a global, randomized, open-label, active-comparator, phase 3 study that will further investigate the efficacy and safety of zanidatamab in combination with chemotherapy with or without tislelizumab as first-line treatment for patients with advanced/metastatic HER2+ GEA. Trial primary completion date: Apr 2022 --> Dec 2022
  • ||||||||||  Tevimbra (tislelizumab-jsgr) / BeiGene, Ziihera (zanidatamab-hrii) / Jazz
    Enrollment closed, Trial primary completion date, Combination therapy, Metastases:  BGB-A317-ZW25-101: Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab (clinicaltrials.gov) -  Apr 4, 2022   
    P1b/2,  N=80, Active, not recruiting, 
    As a case study, we review the mechanisms of action of zanidatamab, an anti-HER2 biparatopic antibody, with improved activity and unique functionality not observed with the parental or combination of parental antibodies. Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Mar 2022
  • ||||||||||  Ziihera (zanidatamab-hrii) / Jazz
    Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov) -  Mar 14, 2022   
    P1,  N=279, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Mar 2022 Recruiting --> Active, not recruiting | N=418 --> 279 | Trial completion date: Mar 2022 --> Oct 2022 | Trial primary completion date: Jan 2022 --> Sep 2022
  • ||||||||||  Tevimbra (tislelizumab-jsgr) / BeiGene, Partruvix (pamiparib) / EMD Serono
    Trial completion date, Trial primary completion date, Metastases:  BGB-A317-290-LTE1: Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (clinicaltrials.gov) -  Mar 8, 2022   
    P3,  N=300, Enrolling by invitation, 
    Recruiting --> Active, not recruiting | N=418 --> 279 | Trial completion date: Mar 2022 --> Oct 2022 | Trial primary completion date: Jan 2022 --> Sep 2022 Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022