AstraZeneca Discontinues
Olaparib Development Programme
in Ovarian Cancer
AstraZeneca announced that its
investigational compound
olaparib will not progress into
Phase III development for the
maintenance treatment of serous
ovarian cancer. Olaparib is an
oral PARP inhibitor that
exploits DNA repair pathways to
preferentially kill cancer
cells.
The decision to discontinue olaparib’s development in serous
ovarian cancer was made
following a review of an interim
analysis of a Phase II study
(Study 19), which indicated that
the previously reported PFS
benefit is unlikely to translate
into an OS benefit, the
definitive measure of patient
benefit in ovarian cancer. In
addition, attempts to identify a
suitable tablet dose for use in
Phase III studies have not been
successful. No new safety
concerns were identified for
patients.
Source:
AstraZeneca
Phase III BRISK-PS Study with
Brivanib did not Meet Primary
Endpoint in HCC Patients
BMS reported that the
Phase III BRISK-PS (Brivanib
Study in HCC Patients at Risk
Post Sorafenib) clinical trial
in patients with hepatocellular
carcinoma (HCC) who failed or
are intolerant to sorafenib did
not meet the primary endpoint of
improving OS vs. placebo.
Brivanib inhibits vascular
endothelial growth factor
receptor (VEGFR) and fibroblast
growth factor receptor (FGFR).
BRISK-PS is a multicenter, double-blind,
randomized study of the investigational
agent brivanib plus BSC vs. placebo plus
BSC in HCC patients who have progressed
on sorafenib. The BRISK-PS study is one
of four Phase III clinical trials
evaluating brivanib in different HCC
patient populations. These ongoing Phase
III studies continue as planned.
Source:
BMS
|
Tivozanib Successfully Demonstrated PFS
Superiority over Sorafenib in RCC
Patients in Phase III TIVO-1 Trial
Aveo and Astellas Pharma announced that
tivozanib demonstrated superiority over
sorafenib in the primary endpoint of PFS
in TIVO-1, a global, randomized, Phase
III clinical trial evaluating the
efficacy and safety of investigational
drug tivozanib compared with sorafenib
in 517 patients with advanced renal cell
carcinoma (RCC). TIVO-1 is the first
registration study in first-line RCC
that is comparing an investigational
agent against an approved VEGF therapy.
All patients in TIVO-1 had clear cell
RCC, had undergone a prior nephrectomy,
and had not previously been treated with
either a VEGF or an mTOR therapy.
Based on the topline analysis of events
in TIVO-1, determined by a blinded,
independent review committee, tivozanib
demonstrated a statistically significant
improvement in PFS with a median PFS of
11.9 months compared with a median PFS
of 9.1 months for sorafenib in the
overall study population. Tivozanib
demonstrated a statistically significant
improvement in PFS with a median PFS of
12.7 months compared with a median PFS
of 9.1 months for sorafenib in the
pre-specified subpopulation of patients
who were treatment-naive (no prior
systemic anti-cancer therapy); this
subpopulation was ~70% of the total
study population. Tivozanib demonstrated
a well-tolerated safety profile
consistent with the Phase II experience;
the most commonly reported side effect
was hypertension, a well-established
on-target and manageable effect of VEGFR
inhibitors.
Source:
Aveo
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