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DRUG:

Ziihera (zanidatamab-hrii)

i
Other names: ZW25, ZW 25, ZW-25, JZP-598, JZP 598, JZP598
Company:
BeOne Medicines, Jazz, Zymeworks
Drug class:
HER2 inhibitor
Related drugs:
3d
Phase 1b/2 Study of Zanidatamab in Combination with Tislelizumab and Chemotherapy in First-Line HER2-Positive Gastric/Gastroesophageal Junction Adenocarcinoma. (PubMed, Clin Cancer Res)
Zanidatamab, in combination with tislelizumab and CAPOX, demonstrated clinically meaningful antitumor activity with a manageable safety profile as first-line therapy for patients with HER2+ GC/GEJC. These results support further development of zanidatamab and tislelizumab with chemotherapy in this patient population in the ongoing phase 3 HERIZON-GEA-01 trial (NCT05152147).
P1/2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Tevimbra (tislelizumab-jsgr) • capecitabine • oxaliplatin • Ziihera (zanidatamab-hrii)
6d
Enrollment closed
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Ziihera (zanidatamab-hrii)
27d
Zanidatamab in combination with docetaxel in first-line HER2-positive breast cancer: results from an open-label, multicenter, phase Ib/II study. (PubMed, ESMO Open)
Zanidatamab demonstrated efficacy and a manageable and tolerable safety profile with docetaxel as first-line treatment in patients with HER2-positive breast cancer. These data support the further development of zanidatamab in this patient population.
P1/2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • EGFR positive
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docetaxel • Ziihera (zanidatamab-hrii)
1m
Neoadjuvant Zanidatamab + Tislelizumab + Gemcitabine/Cisplatin for Selective Bladder Preservation in HER2-Positive MIBC (ChiCTR2500110562)
P2, N=25, Not yet recruiting, Fujian Medical University Union Hospital; Fujian Medical University Union Hospital
New P2 trial
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HER-2 positive
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cisplatin • gemcitabine • Tevimbra (tislelizumab-jsgr) • Ziihera (zanidatamab-hrii)
2ms
Trial completion
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HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 positive + HER-2 overexpression
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Ziihera (zanidatamab-hrii) • evorpacept (ALX148)
2ms
Opportunities and Approaches to Optimising Advanced Cholangiocarcinoma Outcomes in the Era of Targeted Therapies: A Narrative Review. (PubMed, Oncol Ther)
If the tumour is unresectable, the recommended first-line treatment is cisplatin + gemcitabine + durvalumab a programmed cell death ligand 1 [PD-L1] inhibitor or pembrolizumab a programmed cell death protein 1 [PD-1] inhibitor. The development of targeted therapies has led to these treatments being recommended as second- or third-line therapy for patients with actionable gene alterations, while 5-fluorouracil-based chemotherapy is recommended for those without. Robust data support the use of ivosidenib in patients with IDH1 mutations (phase 3), and phase 2 trials showed efficacy of pemigatinib and futibatinib for patients with FGFR2 gene fusions, trastuzumab deruxtecan and zanidatamab for patients with HER2 overexpression/amplification, and dabrafenib + trametinib for patients with BRAFV600E mutations. It is hoped that wider dissemination of the content from this meeting will improve outcomes of patients with CCA by encouraging earlier referral, increasing the use of early molecular testing, an MDT approach, and maximising the use of targeted therapies. Continued efforts to raise awareness, implement education outreach opportunities, and involve patient advocacy groups are encouraged to improve CCA outcomes.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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BRAF V600E • HER-2 overexpression • HER-2 amplification • BRAF V600 • IDH1 mutation • FGFR2 mutation • FGFR2 fusion • IDH mutation + BRAF V600E
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Keytruda (pembrolizumab) • Mekinist (trametinib) • cisplatin • Tafinlar (dabrafenib) • Imfinzi (durvalumab) • gemcitabine • 5-fluorouracil • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lytgobi (futibatinib) • Pemazyre (pemigatinib) • Tibsovo (ivosidenib) • Ziihera (zanidatamab-hrii)
2ms
Enrollment open
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Herceptin (trastuzumab) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Ziihera (zanidatamab-hrii)
3ms
New P2 trial
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PD-L1 (Programmed death ligand 1)
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Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • Ziihera (zanidatamab-hrii)
3ms
Trial completion
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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HER-2 amplification • HER-2 expression • KRAS wild-type • BRAF wild-type • NRAS wild-type
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Avastin (bevacizumab) • cisplatin • gemcitabine • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • Ziihera (zanidatamab-hrii)
3ms
CD123 Targeted Epigenetic Nanotherapy for Fusion Oncoprotein MLL-AF9 Rearranged Acute Myeloid Leukemia in Preclinical and Patient Derived Xenograft Models. (PubMed, Adv Healthc Mater)
si-EzH2@HNPs@ZW25 increased the survival of CD34+CD38- AML patient-derived xenograft mice and augmented the suppression of c-Kit+ LSCs and stimulation of CD11b and Gr-1. In MLL-AF9 AML, C-Myb directly regulates EzH2 through promoter binding wherein si-EzH2@HNPs@ZW25 disrupt this functional crosstalk in AML revealingfuture translational potential of si-EzH2@HNPs@ZW25 as AML therapy.
Preclinical • Journal • IO biomarker
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KIT (KIT proto-oncogene, receptor tyrosine kinase) • EZH2 (Enhancer of zeste 2 polycomb repressive complex 2 subunit) • CD38 (CD38 Molecule) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD34 (CD34 molecule) • ITGAM (Integrin, alpha M) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
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Ziihera (zanidatamab-hrii)