News - HER-2 L755S - LARVOL VERI

1year

NCI-2022-04099: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (clinicaltrials.gov)

P1, N=30, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

1 year ago

Trial suspension • Combination therapy

HER-2 (Human epidermal growth factor receptor 2) • CD4 (CD4 Molecule) • CASP3 (Caspase 3)

HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 L755S • HER-2 A775_G776insYVMA • HER-2 S310F • HER-2 V777L • HER-2 G778_P780dup • HER-2 D769Y • HER-2 L869R • HER-2 V842I • HER-2 H878Y • HER-2 L866M • HER-2 A775 • HER-2 G309A • HER-2 P780-Y781insGSP • HER-2 R678Q • HER-2 R896C • HER-2 T862A • HER-2 YVMA

Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)

over1year

Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers (clinicaltrials.gov)

P2; Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025

over 1 year ago

Trial completion date • Trial primary completion date

HER-2 (Human epidermal growth factor receptor 2) • MUC16 (Mucin 16, Cell Surface Associated)

HER-2 amplification • HER-2 L755S • HER-2 S310F • HER-2 V777L • HER-2 G778_P780dup • HER-2 A775 • HER-2 YVMA

MSK-IMPACT

Kadcyla (ado-trastuzumab emtansine)

over1year

Study of trastuzumab in combination with pertuzumab in patients already treated with a lung cancer harboring a Her2 mutation and receiving docetaxel (clinicaltrialsregister.eu)

P2, N=45, Completed, IFCT

over 1 year ago

New P2 trial • Combination therapy

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation • HER-2 exon 20 insertion • HER-2 L755S • HER-2 exon 20 mutation • HER-2 YVMA • HER-2 exon 23 mutation

Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab)

almost2years

DESTINY-PanTumor01: A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (clinicaltrials.gov)

P2, N=102, Active, not recruiting, AstraZeneca | Trial completion date: Jan 2028 --> Jul 2026

almost 2 years ago

Trial completion date • Metastases

HER-2 mutation • HER-2 L755S • HER-2 S310F • HER-2 V777L • HER-2 S310Y • HER-2 G778_P780dup • HER-2 D769Y • HER-2 V842I • HER-2 A775 • HER-2 D769H • HER-2 G660D + HER-2 S310F • HER-2 P780-Y781insGSP • HER-2 R678Q • HER-2 T862A • HER-2 YVMA

Enhertu (fam-trastuzumab deruxtecan-nxki)

almost2years

Plasma-based analysis of ERBB2 mutational status by multiplex digital PCR in a large series of patients with metastatic breast cancer. (PubMed, Mol Oncol)

Matched tumor samples from six patients identified the same mutations with an 83% concordance rate. In summary, our highly sensitive multiplex digital PCR assays are well suited for plasma-based monitoring of ERBB2 mutational status in patients with MBC.

almost 2 years ago

Journal • Metastases

HER-2 (Human epidermal growth factor receptor 2) • TYK2 (Tyrosine Kinase 2)

HR positive • HER-2 negative • HER-2 mutation • HER-2 L755S • HER-2 S310F • HER-2 V777L • EGFR positive • HER-2 S310Y • HER-2 L869R • HER-2 D769H

almost2years

R2D2: Her2-positive Lung Cancer Treated With Dedicated Drug (clinicaltrials.gov)

P2, N=46, Completed, Intergroupe Francophone de Cancerologie Thoracique | Active, not recruiting --> Completed

almost 2 years ago

Trial completion

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation • HER-2 exon 20 insertion • HER-2 L755S • HER-2 exon 20 mutation • HER-2 YVMA • HER-2 exon 23 mutation

Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab)

almost2years

Clinical characteristics and treatment outcomes of HER2 mutation and HER2 fusion in 22 patients with advanced breast cancer. (PubMed, Thorac Cancer)

Our data demonstrated the clinical benefit of anti-HER2 treatment in Chinese breast cancer patients harboring HER2 mutation and/or HER2 fusion. The value of immunotherapy and treatment selection among individual HER2 variants needs further study.

almost 2 years ago

Retrospective data • Journal • IO biomarker • Metastases

HER-2 (Human epidermal growth factor receptor 2)

HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 L755S • HER-2 S310F • HER-2 V777L • HER-2 L755P • HER-2 V842I • HER-2 H878Y • HER-2 T862A • HER-2 fusion

Herceptin (trastuzumab)

2years

Clinical and genomic landscape of ERBB2 and ERBB3 mutated breast cancer (SABCS 2023)

Here we describe the clinical and genomic characteristics of a large cohort of ERBB2/3-mut breast cancers. We identify a notable enrichment of ERBB2/3-mut in lobular histology and metastatic tumors and tendency for co-alteration with CDH1 and multiple transcription factors reflecting the unique biology of ERBB2/3-mut breast cancers. Further analyses on an expanded cohort (n >6000 pts), including outcomes on HER2-directed antibody-drug conjugates (T-DXd) and targeted therapies such as PI3K inhibitors, will be presented at the 2023 SABCS Annual Meeting.

2 years ago

Clinical

HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ARID1A (AT-rich interaction domain 1A) • NF1 (Neurofibromin 1) • RUNX1 (RUNX Family Transcription Factor 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • CDH1 (Cadherin 1) • FOXA1 (Forkhead Box A1) • MAP3K1 (Mitogen-Activated Protein Kinase Kinase Kinase 1) • GATA3 (GATA binding protein 3)

HER-2 negative • HER-2 mutation • HER-2 L755S • HER-2 S310F • HER-2 V777L • ERBB3 mutation • HER-2 G778_P780dup • ERBB3 G284R

MSK-IMPACT

Enhertu (fam-trastuzumab deruxtecan-nxki)

2years

Mutational landscape and characteristics of ERBB2 in urothelial carcinoma (ESMO Asia 2023)

Conclusions The study provided the landscape of ERBB2 alterations in UC that may benefit from anti-HER2 agents. Consideration should be given to developing trials inclusive of patients with UC harboring ERBB2 alterations.

2 years ago

Tumor mutational burden

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • FGFR3 (Fibroblast growth factor receptor 3) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • RB1 (RB Transcriptional Corepressor 1) • ARID1A (AT-rich interaction domain 1A) • NF1 (Neurofibromin 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CDK12 (Cyclin dependent kinase 12) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • ERCC2 (Excision repair cross-complementation group 2) • KMT2C (Lysine Methyltransferase 2C)

TP53 mutation • TMB-H • HER-2 amplification • HER-2 mutation • HER-2 L755S • NF1 mutation • FGFR3 mutation • HER-2 S310F • ERBB3 mutation

2years

NCI-2022-04099: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (clinicaltrials.gov)

P1, N=30, Recruiting, National Cancer Institute (NCI) | N=18 --> 30

2 years ago

Enrollment change • Combination therapy

CD4 (CD4 Molecule)

Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)

2years

R2D2: Her2-positive Lung Cancer Treated With Dedicated Drug (clinicaltrials.gov)

P2, N=46, Active, not recruiting, Intergroupe Francophone de Cancerologie Thoracique | Trial completion date: Jul 2023 --> Feb 2024

2 years ago

Trial completion date • Combination therapy

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation • HER-2 exon 20 insertion • HER-2 L755S • HER-2 exon 20 mutation • HER-2 YVMA • HER-2 exon 23 mutation

Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab)