FLAURA 2

Question 1

what was the design of FLAURA2

Answer 1

phase 3, international, open-label, randomized in patients with EGFR mutated (exon 19 deletion and exon 21 L858R mutation) mNSCLC who had not previously been on treatment

Question 2

what therapies were the patients radomized to

Answer 2

• Osimertinib 80mg with Pemetrexed 500mg +/- Carbo or Cisplatin
• Osimertinib monotherapy

Question 3

what was the Primary Endpoint of FLAURA2 according to Investigator Assessment

Answer 3

• PFS
• response
• safety

Question 4

how many total patients were in FLAURA2

Answer 4

557

Question 5

of the 557, how many were in the Osi + Chemo vs. Osi monotherapy

Answer 5

• 279
• 278

Question 6

what % of patients had Exon 19 Deletions for the Osi + Chemo vs Osi mono

Answer 6

• 61%
• 60%

Question 7

what % of patients patients had Exon 21 Mutations in the Osi + Chemo vs Osi Mono

Answer 7

• 38
• 38

Question 8

what % of patients had CNS Mets in the Osi + Chemo vs. Osi mono

Answer 8

• 42%
• 40%

Question 9

what was the PFS for Osi combo vs Osi mono as assessed by investigators

Answer 9

• 25.5 mo.
• 16.7 mo.

Question 10

what was the PFS for Osi combo vs Osi mono in CNS Mets as assessed by investigators

Answer 10

• 24.9 mo.
• 13.8 mo.

Question 11

what was the ORR for Osi combo vs Osi mono as assessed by investigators

Answer 11

• 83%
• 76%

Question 12

what was the DOR for Osi combo vs Osi mono as assessed by investigators

Answer 12

• 24 mo.
• 15.3 mo.

Question 13

how man patients experienced AEs in FLAURA2

Answer 13

276 patients