Profile 1014 Veeva Content

Question 1

PFS vs. Chemotherapy

Answer 1

10.9 vs. 7.0

Question 2

Total patients

Answer 2

343

Question 3

Total number of patients in label now for safety and efficacy

Answer 3

1669

Question 4

Patients had received ….. treatment.

Answer 4

no prior systemic treatment for metastatic disease

Question 5

Chemo therapy types

Answer 5

Pemetrexed and cisplatin for carboplatin every 3 weeks for up to 6 cycles

Question 6

% of stable brain metastasis in the Xalkori arm

Answer 6

26%

Question 7

% of stable brain metastasis in chemo arm

Answer 7

27%

Question 8

Tumor responses based in IRR

Answer 8

74% vs. 45%

Question 9

Duration of response

Answer 9

11.3 months vs. 5.3

Question 10

Median time to response

Answer 10

Xalkori 1.4 months vs. 2.8 months

Question 11

OS not met with ….% switching to Xalkori

Answer 11

70%

Question 12

Serious AE were reported in …..% of pts

Answer 12

34%

Question 13

Most frequent serious AE reported with Xalkori and %

Answer 13

dyspnea 4.1%

pulmonary embolism 2.9%

Question 14

Permanent DC for AE was …..%

Answer 14

8.2%

Question 15

Most frequent reason permanent DC with Xalkori

Answer 15

elevated transaminases 1.2%
hepatotoxicity 1.2%
ILD 1.2%

Question 16

Dose reductions were required in …% of pts

Answer 16

6.4%

Question 17

Most frequent reasons for dose reductions

Answer 17

nausea 1.8%

elevated transaminases 1.8%