39
Phase III TERRA:
TAS-102 in Asian patients with mCRC
Asian Study: China, Korea and Thailand
Primary endpoint:
OS
Secondary endpoints included:
PFS, ORR, DCR, DoR, TTF, OS and PFS according
to
KRAS
mutation status
DCR = disease control rate; DoR = duration of response; NDA = new drug
application; ORR = overall response rate; TTF = time to treatment failure
Kim T, et al. ESMO 2016. Abstract 465PD (poster discussion session).
*Patients had received ≥2 prior lines of standard chemotherapy,
including fluoropyrimidines, irinotecan, and oxaliplatin
.
Prior anti-VEGR or anti-EGFR therapy was allowed
but not mandatory
.
LONSURF + BSC
(n=271)
mCRC refractory/intolerant
to standard chemotherapies
(N=406)*
Placebo + BSC
(n=135)
R
Treatment
continued until PD,
toxicity or patient
refusal
2:1
Prior targeted biological therapy,
n (%)
LONSURF
(n=271)
Placebo
(n=135)
None
148 (54.6)
66 (48.9)
Any (anti-VEGF or anti-EGFR or both)
123 (45.4)
69 (51.1)
Anti-VEGF only
52 (19.2)
27 (20.0)
Anti-EGFR only
46 (17.0)
25 (18.5)
Both anti-VEGF and anti-EGFR
25 (9.2)
17 (12.6)
Baseline Characteristics
•
63.3% (257/406) of patients were
KRAS
wt
–
In the LONSURF and placebo treatment
arms, 63.5% (172/271) and 63.0 %
(85/135) of patients were
KRAS
wt
