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26

During the maintenance phase, 54.2% (N=39) of patients received CTX administration every

two weeks and 45.8% (N=33) once a week (Estudio DIRECT)

Guigay J, et al. ESMO 2016 (Abstract 967P))

*Bi-weekly administration of cetuximab is off-label

Overall survival in maintenance phase

Progression-free survival in maintenance phase

12-month

OS rate %

(95% CI)

Weekly (n=21)

62.6 (43.6, 76.8)

Bi-weekly (n=31)

77.0 (59.1, 87.8)

12-month PFS, Logrank p=0.216

12-month OS, Logrank p=0.197

12-month

PFS rate %

(95% CI)

Weekly (n=6)

18.2 (7.4, 32.8)

Bi-weekly (n=12)

27.5 (14.3, 42.3)

Survival probability (%)

100

90

80

70

60

50

40

30

20

10

0

0

3

6

9

12

Time to event (months)

At risk

Time

Weekly

Bi-weekly

0

33

39

3

32

39

6

30

37

9

24

25

12

19

23

Survival probability (%)

100

90

80

70

60

50

40

30

20

10

0

0

3

6

9

12

Weekly

Bi-weekly

Weekly

Bi-weekly

Time to event (months)

0

33

39

3

31

38

6

20

28

9

11

14

12

6

9