Denosumab Superior to
Zometa in Prostate Cancer Patients with
Bone Metastases
Amgen announced that a
pivotal, Phase III, head-to-head trial
evaluating denosumab (a monoclonal
antibody targeting the receptor
activator of NF-κB ligand (RANKL))
against Zometa (zoledronic acid) in the
treatment of bone metastases in 1,901
men with advanced prostate cancer met
its primary and secondary endpoints.
Denosumab demonstrated superiority over
Zometa for delaying the time to the
first on-study skeletal-related event (SRE)
(fracture, radiation to bone, surgery to
bone, or spinal cord compression) and
reducing the rate of multiple SREs. Both
results were statistically significant.
Overall rates of adverse
events and serious adverse events,
including infections, were generally
similar between the two arms.
This study is the last of
three pivotal trials conducted in over
5,700 advanced cancer patients,
investigating the potential of denosumab
to treat bone metastases. Results from
the previous two trials were presented
in September 2009. These three studies
will form the basis of the clinical
evidence package for denosumab in
advanced cancer, which will be submitted
to regulatory authorities later this
year.
Source:
Amgen
Phase II Trial of
Picoplatin in mCRC meets Primary
Endpoint
Poniard Pharmaceuticals
presented final data from a randomized,
controlled Phase II trial of picoplatin
(a DNA synthesis inhibitor) in
metastatic colorectal cancer (mCRC)
patients, at the American Society of
Clinical Oncology (ASCO) 2010
Gastrointestinal (GI) Cancers Symposium
in Orlando, Florida, held on January
22-24, 2010. The trial evaluated
picoplatin as a neuropathy-sparing
alternative to oxaliplatin for the
first-line treatment of mCRC in 101
patients who had not received prior
chemotherapy. The primary objective of
the trial was to measure the relative
incidence and severity of neuropathy
with picoplatin in combination with the
5-fluorouracil and leucovorin (FOLPI)
regimen against oxaliplatin in
combination with the 5-fluorouracil and
leucovorin (FOLFOX) regimen.
The study met its primary
objective, as the FOLPI regimen was
associated with a statistically
significant reduction in neurotoxicity,
compared to the FOLFOX regimen.
Regardless of grade, neuropathy was at
26% in FOLPI-treated patients and 62% in
FOLFOX-treated patients. No grade 3/4
neuropathy was observed with FOLPI. The
results also suggested that FOLPI had
efficacy similar to that of FOLFOX. "We
believe that these Phase 2 data confirm
picoplatin's potential as an alternative
to oxaliplatin in the first-line
treatment of metastatic CRC and will
support the design of a Phase 3 study.
Our ultimate goal is to secure a
strategic partnership to support further
development of picoplatin in CRC and
other solid tumor indications, including
prostate and ovarian cancers," said
Jerry McMahon, PhD, Chairman and CEO of
Poniard.
Source:
Poniard
Phase III Trial of Sutent
in Patients with Pancreatic NETs meets
Primary Endpoint
Pfizer announced final
results from a randomized Phase III
trial of Sutent (sunitinib malate) in
patients with advanced pancreatic
neuroendocrine tumors (NETs), at the
2010 ASCO GI Cancers Symposium in
Orlando, Florida. In this trial,
patients were randomized to either the
sunitinib (n = 86) plus best supportive
care arm or the placebo plus best
supportive care arm (n = 85). An
independent Data Monitoring Committee (DMC)
recommended to halt the trial in
February 2009 because sunitinib
demonstrated significant benefits and
the primary endpoint (PFS) was met.
Median PFS was 11.4 months in sunitinib-treated
patients, compared to 5.5 months in
placebo-treated patients. Sutent also
prolonged OS, a secondary endpoint of
the trial. These findings served as the
basis for the recent filings of
supplemental applications for sunitinib
in the treatment of pancreatic NETs with
regulatory authorities in the US,
Europe, and Canada. Sutent is approved
for the treatment of advanced/metastatic
renal cell carcinoma and
gastrointestinal stromal tumor after
disease progression or intolerance to
imatinib mesylate.
Source:
Pfizer
Survival Benefits with
KRX-0401 in mCRC Treatment
Keryx Biopharmaceuticals
reported updated results from a Phase II
trial of KRX-0401 (perifosine) (a PI3K/Akt
pathway inhibitor of cancer) in
combination with capecitabine as a
treatment for advanced, metastatic
colon
cancer (mCRC), at the 2010 ASCO
GI Cancers Symposium. In this
randomized, double-blind,
placebo-controlled study, heavily
pre-treated patients with 2nd
or 3rd line mCRC were
randomized to receive capecitabine plus
either perifosine or placebo. The study
enrolled 38 patients, of which 34 were
third-line or greater. The primary
endpoint of the study was to measure
time to progression (TTP). Overall
response rate (ORR) and OS were measured
as secondary endpoints. Perifosine +
capecitabine more than doubled the TTP,
compared to capecitabine + placebo (28
weeks vs. 11 weeks). 35 patients were
evaluable for response. The ORR was 20%
with capecitabine + perifosine vs. 7%
with capecitabine + placebo, and the
respective clinical benefit rates were
74% vs. 40%. Median OS was 18 months in
the capecitabine + perifosine group vs.
11 months in the capecitabine + placebo
group.
Keryx also reached an
agreement with the FDA regarding a
Special Protocol Assessment (SPA) on the
design of a Phase III trial for
perifosine in patients with refractory
mCRC. The US-based Phase III trial X-PECT
will evaluate the drug in combination
with capecitabine. Nearly 430 patients
will be recruited for the trial, which
is due to start in Q2 2010. Study
completion is due in H2 2011. Keryx
in-licenses Perifosine from Aeterna
Zentaris in the US, Canada, and Mexico.
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