Roche announces FDA approval for Venclexta plus Gazyva for people with previously untreated chronic lymphocytic leukaemia - Seite 3

CLL14 Study Results
Treatment arm	Venclexta + Gazyva (n=216)	Gazyva + chlorambucil (n=216)
Progression Free Survival (PFS)a
Median PFS	Independent Review Committee (IRC): Not reached		IRC: Not reached
Number of Events, n (%)	29 (13)	79 (37)
	IRC: HR = 0.33 (95% CI 0.22-0.51), p<0.0001
Response Rates
ORR % (95% CI)	85 (79-89)	71 (65-77)
p value	0.0007
CR/CRi	50	23
p value	<0.0001
Minimal Residual Disease (MRD)b
MRD-negative, %, bone marrow (95% CI)	57 (50-64)		17 (12-23)
p value	<0.0001
MRD-negative, % peripheral blood (95% CI)	76 (69-81)		35 (29-42)
p value	<0.0001
Overall Survival (OS)
OS	Not reached		Not reached

^a Approval based on secondary endpoint of PFS evaluated by IRC; data at median follow-up of 28 months