Phase 2 Evaluation of Zanidatamab Flashcards
Horizon BTC-01 enrolled how many patients?
87
Cohort 1 had how many patients
80
HER2 + disease in Cohort1 was defined as
IHC2+/3+, ISH Positive
Cohort 2 had how many patients
7
Primary endpoint of BTC 01?
ORR
Secondary endpoint of BTC 01?
DoR by ICR
Cohort 1 average age?
64
% had GBC
51% (41 patients)
How many had IHC3+
78% (62 patients)
How many were stage 4
89%
How many had greater than one prior line?
41%
Previous systemic therapies included______
G (100%), G+C (76%), Fluoropyrimidine based 34%, PD-1 or PD-L1 inhibitor 26%, Fluoropyrimidine 6%
In Herizon BTC-01 the primary endpoint was______
ORR 41.3%
In Herizon BTC 01 ______ patients had a CR
2
In Herizon BTC 01 the median DOR was_____
14.9 months
In Herizon BTC 01 Patients who had IHC 3+ and ISH amplified had ORR and DOR of ______ and _______
52% and 15 months
Among patients with IHC2+ and ISH amplified the cORR was ______ and median DOR was______
6% and NE
The most common grade 3 AE’s were ____
Anemia (13%), Diarrhea (9%), ALT/AST increases(5%) and Fatigue (4%)
In Herizon BTC 01 the most common grade 3 lab abnormalities were______
Low Hb (14%), elevated ALT (8%)/AST (10%), Low sodium (10%) and low lymphocytes (8%)
in Herizon BTC 01 treatment emergent AE’s led to dose reductions in ______
4% due to Diarrhea (3%), Nausea (1%) and decreased weight (1%)
In Herizon BTC 01 the discontinuation rate due to AE’s was____
2.5%
In Herizon BTC 01 AE’s leading to the permanent discontinuation of Zanidatamab were___________
decreased ejection fraction (1.3%) and pneumonitis (1.3%)
In Herizon BTC 01 serious AE’s occurred in ____________
13.8%: those that occurred in >2% patients included diarrhea (3%) and fatigue (3%)
The ZWI-ZW25-201 Study is_____
A phase 2 in combination with chemo in 1L tx for patients with HER2 expressing BTC, GEA or colorectal cancer
