HERTHENA LUNG-01: Patritimab Deruxtecan DXd/ Zaherity Flashcards
what was the Study Design of HL01
ongoing, global, phase 2 pivotal trial
what was the Purpose of the trial
evaluate the antitumor activity of patrutimab deruxtecan (HE3-DXd)/ Zaherity in patients with locally advanced or metastatic EGFRm (exon 19 deletion or exon 21 L858R point mutation) NSCLC whose disease has progressed on or after Osimertinib and >1 platinum-based chemo
what were the Key Inclusion criteria
- locally advanced/ metastatic EGFRm (exon 19 or exon 21 L858R) NSCLC
- .platinum based chemo AND Osimertinib
- pretreatment tumor biopsy or archived tissue (within >3 mons)
- inactive or previously treated brain mets
how many Patients were included in the trial
225
what were the Primary Endpoints
- ORR: 29.8% (CR: 0.4% + PR: 29.4%)
what weas the Key Secondary Endpoints
- DOR: 6.4 mo.
what were the Other y Secondary Endpoints
- DCR: 73.8% (ORR: 29.8% + SD:44%)
- PFS: 5.5 mo.
- OS: 11.9 mo.
what Exploratory Analysis was looked at
brain mets (occurs in 70% of patients with advanced EGFRm NSCLC)
what were the Endpoints of the Brain Mets Exploratory Analysis
- ORR; 20%
- DCR: 80%
- DOR: 9.2 mo.
what were the Endpoints of the Brain Mets Exploratory Analysis in patients with no prior radiotherapy of the brain
- ORR: 33.3%
- DCR: 76.7%
- DOR: 8.4 mo.
what dose of Zaherity was used in HL01
5.6mg/kg
what were the Top 3 All Grade AEs in HL01
- Nausea: 66%
- Thrombocytopenia: 44%
- Decreased Appetite: 42%
what were the top 3 Grade >3 AEs in HL01
- Thrombocytopenia: 21%
- Neutropenia: 19%
- Anemia: 14%
what % of Serious AEs occur in HL01
40%
what % of Drug-related Serious AEs occur in HL01
15.1%
