Treatment of BTC

Question 1

Two regimens were approved as First line therapy without a requirement for any specific molecular aberration

Answer 1

Durva/Pembro + Gem/Cis

Question 2

ABC-06 Study

Answer 2

FOLFOX+ASC vs. ASC

Question 3

Primary End Point of ABC 06

Answer 3

OS

Question 4

Secondary Endpoints

Answer 4

PFS, ORR

Question 5

Median OS was _____months longer with those treated with Folfox+ASC

Answer 5

0.9

Question 6

In ABC 06 the OS rate at 1 year was________

Answer 6

25.9% for Folfox+ASC
11.4% for ASC

Question 7

mPFS in Folfox+ASC was_______ and 1 year PFSm _____, while ORR rate was____

Answer 7

4.0 months, 8.6%, 5%

Question 8

MyPathway, was the evaluation of___

Answer 8

Trastuzumab and Pertuzumab

Question 9

Mypathway implemented a ________ trial

Answer 9

Basket

Question 10

The basket trial enrolled____________

Answer 10

patients with different tumor type but has HER2 amplification / HER2 overexpression or both.

Question 11

How many were enrolled?

Answer 11

39

Question 12

The primary endpoint was ____ and the secondary end point _______

Answer 12

ORR and DCR, DoR, PFS, medOS, safety

Question 13

How many CR’s? and How many PR’s

Answer 13

0 and 9

Question 14

Overall response rate?

Answer 14

23%

Question 15

Grade 3-4 treatment emergent events were observed in _____ % patients

Answer 15

46%

Question 16

The most common grade 3-4 events were_____

Answer 16

Increased ALT/AST/ALP/Bilirubin, and Abdominal pain

Question 17

The HERB and Destiny Pan Tumor 02 evaluated________, and were Phase ____

Answer 17

T-Dxd, Phase 2 studies

Question 18

Enhertu is indicated for _______

Answer 18

HER2 + Breast, HER2 mutated lung, Previously treated unresectable or metastatic HER2 + (IHC3+) solid tumors

Question 19

HERB trial was _______ arm, with N=___

Answer 19

Single, 32

Question 20

HERB had _____HER2 +, and _____ HER2 -Low-Overexpressing

Answer 20

24, 8

Question 21

HERB Primary Endpoint

Answer 21

ORR in HER2+ disease (36.4%)

Question 22

HERB secondary endpoint

Answer 22

ORR in HER2 low expressing disease (12.5%)

Question 23

Among 22 patients with HER2+ (IHC3+) BTC the ORR was______, while the DOR ranged from _____to______

Answer 23

45.5%, 2.1 to >22 months

Question 24

Grade >3 treament emergent AE’s occurred in _______ the most common being ______ , ______ and ________

Answer 24

81.3%, Anemia, Neutropenia and Leukemia.

Question 25

Destiny Pan Tumor 02 evaluated ____ in patients with ________

Answer 25

T-Dxd, HER2 over expressing solid tumors

Question 26

(Destiny)The primary endpoint was _____, ____%, mPFS ____, DOR _____

Answer 26

ORR, 22%, 4.6 mos, 2.1 to>22 months

Question 27

(Destiny) Secondary endpoint was

Answer 27

DOR,DCR,PFS, OS

Question 28

Progress and Unmet need - 5 year survival rates for BTC?

Answer 28

20% GBC, 11% eCCA, 9% iCCA

Question 29

In patients with unresectable, locally advanced or metastatic BTC the ORR to second line therapy is_____ due primarily to ______

Answer 29

<10%, quickly progressing disease

Question 30

Median OS in second ine is_____

Answer 30

Approximately 6 months

Question 31

In patients with HER2 over expressing or HER2 amplified BTC, the efficacy of current treatment is limited. In the my pathway, herb and destiny studies HER2 targeted therapies yielded ORR’s of ______ and median OS of ______

Answer 31

22% to 45%, 7.0 to 10.9 months

Question 32

_____ is a molecular testing technique that can detect chromosome abnormalities such as_______, ________ and ________

Answer 32

ISH, Copy Number, Amplification and structural abnormalities (Gene rearrangements)