IBRANCE Stronger Together Piece

Question 1

IBRANCE is a ….

Answer 1

• First in class CDK 4/6 inhibitor

- Is a targeted CDK 4/6 inhibitor

Question 2

CDK 4/6 is also active in …

Answer 2

• Healthy cells

- which can result in side effects some of which can be serious

Question 3

The CDK 4/6 cyclin D1 dependent complex initiates cell cycle transition between the ….. to ….. phase

Answer 3

G1 to S

Question 4

Inhibition of CDK 4/6 helps control cell growth by….

Answer 4

inducing G1 arrest reducing cell cycle progression

Question 5

One pathway, two targets - twice the impact because…

Answer 5

Endocrine therapy suppresses growth signals and Ibrance interrupts cell cycle progression

Question 6

Paloma 1 summary of patient characteristics

Answer 6

The paloma 1 patient population was generally well balanced and inclusive of visceral, bone, and other sites of metastasis.

Question 7

Paloma 1 number of patients

Answer 7

165

Question 8

Paloma 1 PFS

Answer 8

20.2 vs. 10.2

Question 9

First line IBRANCE and letrozole reduced the risk of disease progression by …%

Answer 9

51%

Question 10

ORR of Paloma 1

Answer 10

55.4% vs. 39.4%

Question 11

Paloma 3 number of patients

Answer 11

521

Question 12

Paloma 3 PFS

Answer 12

9.5 vs. 4.6

Question 13

IBRANCE and Fulvestrant reduced the risk of disease progression by ..%

Answer 13

54%

Question 14

Paloma 3 ORR

Answer 14

24.6% vs. 10.9%

Question 15

Median duration of response was …. in Paloma 3

Answer 15

9.3 months vs. 7.6%

Question 16

Warning and precautions (3)

Answer 16

Neutropenia, PE, Embryo fetal toxicity

Question 17

% of patients that did not discontinue due to AE in Paloma 1

Answer 17

92%

Question 18

% of patients that did not discontinue due to AE in Paloma 3

Answer 18

94%

Question 19

Dose reductions due to AE of any grade in both studies (%)

Answer 19

36%

Question 20

Dose of fulvestrant

Answer 20

500mg

Days 1, 15, 29, and monthly thereafter