Pooled Analysis: TROPION-Lung05 & TROPION-Lung01

Question 1

how many Total patients were in TL05 & TL01

Answer 1

• 137 in TL05
• 604 in TL01

Question 2

how many arms did TL05 have and what therapies (with dosage and patients) were included

Answer 2

• 1 arm
• Datroway 6mg/kg Q3W, (137 patietients)

Question 3

how many arms did TL01 have and what therapies (with dosage and patients) were included

Answer 3

• 2 arms
• Datroway 6mg/kg Q3W (299 patients)
• Docetaxol 75mg/kg Q3W (305 patients)

Question 4

how many Total EGFR patients were in the pooled data

Answer 4

117

Question 5

how many EGFR patients were in TL05

Answer 5

78

Question 6

how many EFGR patients were in TL01

Answer 6

39

Question 7

what % of patients had EGFR Exon 19 deletions

Answer 7

51.3%

Question 8

what % of patients had EGFR Exon 21 L858R mutations

Answer 8

31.6 (32)%

Question 9

what were the inclusion criteria for TL05

Answer 9

• presence of >1 actionable alteration
• > line of targeted therapy
• 1-2 prior cytotoxic agent incl. platinum in metastatic setting

Question 10

what were the inclusion criteria for TL01

Answer 10

• presence of actionable alterations
• 1-2 approved targeted therapies + platinum chemo and < 1 anti-PDL1 mAB
• mo prior docetaxel

Question 11

what were the actionable alterations in the pooled data

Answer 11

• ALK
• BRAF
• EGFR
• METex14
• NTRK
• ROS1
• RET

Question 12

what was the median age for the pooled data

Answer 12

63

Question 13

what % of patients had Brain Mets

Answer 13

30.8 (31)%

Question 14

what was the prior Median lines of therapy in the pooled data

Answer 14

3

Question 15

what % of patients had Prior treatment with Osi

Answer 15

82.1%

Question 16

what were the primary endpoints of the pooled data

Answer 16

• ORR
• DOR
• PFS
• OS

Question 17

what was the confirmed ORR from the pooled Datroway EGFRm data (117) vs. the Prior Osi (96)

Answer 17

• 42.7 (43)% for Datroway
• 44.8 (45)% for Osi

Question 18

what was the confirmed CR & PR from the pooled Datroway EGFRm data (117) vs. the Prior Osi (96)

Answer 18

• CR: 4.3%/ PR: 38.5 (39)%, Datroway
• CR: 4.2%/ PR: 40.6 (41)%, Osi

Question 19

what was the confirmed SD from the pooled Datroway EGFRm data (117) vs. the Prior Osi (96)

Answer 19

• 41.0%
• 38.5 (39)%

Question 20

what was the confirmed DOR from the pooled Datroway EGFRm data (117) vs. the Prior Osi (96)

Answer 20

• 7 mo.
• 6.9 (7) mo.

Question 21

what was the confirmed PFS from the pooled Datroway EGFRm data (117) vs. the Prior Osi (96)

Answer 21

• 5.8 mo.
• 5.7 mo.

Question 22

what was the confirmed OS from the pooled Datroway EGFRm data (117) vs. the Prior Osi (96)

Answer 22

• 15.6 (16) mo.
• 14.7 (15) mo.

Question 23

what were the % of TRAE (Treatment Related Adverse Events) Dose Adjustments for…
- Reductions
- Delay/ Interruptions
- Discontinuations

Answer 23

• Reductions: 22%
• Delay/ Interruptions: 23%
• Discontinuation: 5%

Question 24

what were the TRAEs >10%

Answer 24

• Stomatitis/ mucositis: 50%
• Alopecia: 49%
• Nausea: 46%

Question 25

what were the AESIs (Adverse Events of Special Interest) and their %

Answer 25

- Stomatitis/ mucositis: 69% - Ocular events: 32% - ILD: 4%

Question 26

what were the AESIs (Adverse Events of Special Interest) that were Grade 3 and percentage

Answer 26

- Stomatitis/ mucositis: 9% - Ocular events: 3% - ILD: 4%

Question 27

what was the median time to onset of Stomatitis/ mucositis

Answer 27

29 days

Question 28

what was the time to asymptomatic resolution

Answer 28

50 days

Question 29

what % of stomatitis/ mucositis were resolved

Answer 29

82%