TROPION LUNG-05: Datopotamab Deruxtecan DXd/ Datroway

Question 1

what was the study design of TL05

Answer 1

global, phase 2, ongoing, single arm, open label

Question 2

what was the timeframe for TL05

Answer 2

March 29, 2021-December 14, 2022

Question 3

what was the Median Study Duration

Answer 3

15.2 mo.

Question 4

what was the Median Treatment Duration

Answer 4

4.4 mo.

Question 5

what was the purpose of TL05

Answer 5

evaluate safety and efficacy of Dato-DXd in patients with advanced mNSCLC with actionable biomarkers who have progressed on a targeted therapy AND platinum based chemo

Question 6

how many patients were enrolled in TL-05

Answer 6

137

Question 7

what were the Inclusion Criteria for TL05

Answer 7

• mNSCLC
• actionable genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exoon 14 skipping, RET
• 1-2 platinum
• 1 -2 targeted therapies
• progression

Question 8

what were the Exclusion Criteria of TL05

Answer 8

• prior treatment with Trop2 directed therapy
• prior treatment with topoisomerase I targeted chemotherapy
• active brain mets
• ILD
• KRAS mutations

Question 9

what was the Median Age

Answer 9

61

Question 10

what % of patients received 3 or more lines of therapy

Answer 10

71.5%

Question 11

what % of patients received Immunotherapy

Answer 11

35.8%

Question 12

what % of patients had a history of Brain Mets

Answer 12

51.1%

Question 13

what % of patients had EGFR Mutations

Answer 13

56.9%

Question 14

what % of patients had exon 19 Deletions, exon 21 L858R mutations and T90M mutations

Answer 14

49.6%

Question 15

what % of patients had ALK Rearrangements

Answer 15

24.8%

Question 16

what was the Primary Endpoint of TL05

Answer 16

ORR: 35.8 (CR:2.9% + PR: 32.8%)

Question 17

what were the Secondary Endpoint of TL05

Answer 17

• DOR: 7.0 mo.
• DCR: 78.8% (ORR: 35.8% + SD: 43%)
• PFS: 5.4 mo.
• OS: 13.6 mo.

Question 18

how many patients had EGFR

Answer 18

78

Question 19

what were the endpoints for the EGFR patients

Answer 19

• ORR: 43.6%
• DOR: 7.0 mo.
• DCR: 82.1%
• PFS: 5.8 mo.
• OS: 18.3 mo.

Question 20

how may of the EGFR patients had a Complete Response

Answer 20

4

Question 21

how many patients had ALK rearrangements

Answer 21

34

Question 22

what were the endpoints for the ALK patients

Answer 22

• ORR: 23.5%
• DOR: 7.0 mo.
• DCR: 73.5%
• PFS: 4.3 mo.
• OS: 9.3 mo.

Question 23

how many ALK patients had a CR and PR

Answer 23

• CR: 0 patients
• PR: 8 patients

Question 24

what dose of Data was used in TL05 and it’s dosing regimen

Answer 24

• 6.0 mg/kg
• IV QD every 3 weeks on day 1 of each 21 day cycle

Question 25

what was the initial infusion and subsequent infusion schedule

Answer 25

- 90 min. - 30 min.

Question 26

what was the most common reason for treatment discontinuation and the %

Answer 26

progressive disease: 70.8%

Question 27

what were the top 3 Any Grade TRAEs (treatment related adverse events)

Answer 27

- stomatitis: 56.2% - nausea: 54.7% - alopecia: 49.6%

Question 28

what were the top 3 Grade > 3 TRAEs (treatment related adverse events)

Answer 28

- stomatitis: 9.5% - nausea & decreased appetite: 2.2% - constipation: 1.5%

Question 29

what were the top 3 AEIs (adverse events of special interest)

Answer 29

- oral stomatitis/ mucositis: 65.7% - ocular surface events: 26.3% - ILD: 3.6%

Question 30

what 2 AEs were associated with Death and were they attributed to Dato-DXd

Answer 30

- dyspnea - disease progression - no

Question 31

what were the 3 Grade >3 Ocular events

Answer 31

- corneal disorder - cornea verticillate - punctate keratitis

Question 32

what are the rates for... - Dose Discontinuation - Dose Interruption - Dose Reduction

Answer 32

- discontinuation: 5.1% - interruption: 21.2% - reduction: 19.7%