Phase 2 Evaluation of Zanidatamab

Question 1

Horizon BTC-01 enrolled how many patients?

Answer 1

87

Question 2

Cohort 1 had how many patients

Answer 2

80

Question 3

HER2 + disease in Cohort1 was defined as

Answer 3

IHC2+/3+, ISH Positive

Question 4

Cohort 2 had how many patients

Answer 4

7

Question 5

Primary endpoint of BTC 01?

Answer 5

ORR

Question 6

Secondary endpoint of BTC 01?

Answer 6

DoR by ICR

Question 7

Cohort 1 average age?

Answer 7

64

Question 8

% had GBC

Answer 8

51% (41 patients)

Question 9

How many had IHC3+

Answer 9

78% (62 patients)

Question 10

How many were stage 4

Answer 10

89%

Question 11

How many had greater than one prior line?

Answer 11

41%

Question 12

Previous systemic therapies included______

Answer 12

G (100%), G+C (76%), Fluoropyrimidine based 34%, PD-1 or PD-L1 inhibitor 26%, Fluoropyrimidine 6%

Question 13

In Herizon BTC-01 the primary endpoint was______

Answer 13

ORR 41.3%

Question 14

In Herizon BTC 01 ______ patients had a CR

Answer 14

2

Question 15

In Herizon BTC 01 the median DOR was_____

Answer 15

14.9 months

Question 16

In Herizon BTC 01 Patients who had IHC 3+ and ISH amplified had ORR and DOR of ______ and _______

Answer 16

52% and 15 months

Question 17

Among patients with IHC2+ and ISH amplified the cORR was ______ and median DOR was______

Answer 17

6% and NE

Question 18

The most common grade 3 AE’s were ____

Answer 18

Anemia (13%), Diarrhea (9%), ALT/AST increases(5%) and Fatigue (4%)

Question 19

In Herizon BTC 01 the most common grade 3 lab abnormalities were______

Answer 19

Low Hb (14%), elevated ALT (8%)/AST (10%), Low sodium (10%) and low lymphocytes (8%)

Question 20

in Herizon BTC 01 treatment emergent AE’s led to dose reductions in ______

Answer 20

4% due to Diarrhea (3%), Nausea (1%) and decreased weight (1%)

Question 21

In Herizon BTC 01 the discontinuation rate due to AE’s was____

Answer 21

2.5%

Question 22

In Herizon BTC 01 AE’s leading to the permanent discontinuation of Zanidatamab were___________

Answer 22

decreased ejection fraction (1.3%) and pneumonitis (1.3%)

Question 23

In Herizon BTC 01 serious AE’s occurred in ____________

Answer 23

13.8%: those that occurred in >2% patients included diarrhea (3%) and fatigue (3%)

Question 24

The ZWI-ZW25-201 Study is_____

Answer 24

A phase 2 in combination with chemo in 1L tx for patients with HER2 expressing BTC, GEA or colorectal cancer

Question 25

The Herizon BTC 302 study is________

Answer 25

A phase 3 evaluating zanidatamab in combination with SOC (G+C/ w or w/oDurva or Pembro) therapy as 1L treatment or patients with HER2+ BTC