Key Highlights
Can Amgen’s talimogene become an
optimal therapy for melanoma?
Immunotherapy is a major new option for
patients with melanoma. Early results from the
Phase III OPTiM trial suggest that the oncolytic
immunotherapy talimogene (BioVex, Amgen)
might become a player soon in this indication;
however, overall survival data will be required
before this agent will be accepted by the
clinical community.
Votrient POIZEd to become a new option for
maintenance therapy in advanced ovarian
cancer
Votrient® (pazopanib, GlaxoSmithKline)
showed a achieved its primary endpoint of
progression-free survival benefit in the AGOOVAR16 (POIZE) trial. Similar to the US fate
for Avastin® (bevacizumab, Genentech/Roche),
the current lack of an overall survival benefit
could affect Votrient’s chance for approval for
use as a maintenance therapy.
The battle between Avastin and Erbitux in
colorectal cancer heats up with the FIRE-3
results at ASCO 2013
In the U.S., Avastin enjoys market leadership
as a first-line therapy in metastatic colorectal
cancer. For patients with KRAS wildtype
disease in Europe and Japan, that leadership
is shared with Erbitux® (cetuxumab, BristolMyers Squibb/Eli Lilly/Merck KGaA). The FIRE3 study was one of two trials designed to test
the two agents head-to-head. Although the trial
showed an overall survival advantage for
Erbitux, questions regarding trial design and
the lack of a progression-free benefit for
Erbitux suggest that the current market
positions will remain until results from the
second trial (CALGB 80405) are made public.
Overcoming resistance in breast cancer: Is
there a role for mTOR inhibition in HER2+
disease?
Afinitor® (everolimus, Novartis) is currently
approved in combination with Aromasin®
(exemestane, Pfizer) for HR+/HER2- breast
cancer patients who have failed a prior
aromatase inhibitor. The BOLERO-3 trial was
Novartis’ first chance to introduce Afinitor to
HER2+ patients. Unless the results of a second
trial (BOLERO-1) are more favorable, the
modest PFS benefit for Afinitor in BOLERO-3
might relegate the agent to patients in the thirdline or later.
PD-1/PD-L1 immune checkpoint blockade: It
just keeps getting better
Physicians have been excited about PD-1
inhibitors since the first presentation of data
last year on nivolumab (Bristol-Myers Squibb).
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This issue of Oncology Conference Insight highlights significant
results presented at the 2013 American Society of Clinical
Oncology (ASCO) Annual Meeting, which took place May 31June 4 in Chicago, Illinois.
The discussion pieces available on this website summarize
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More recently, inhibitors to a companion
immune checkpoint molecule, PD-L1, are
being examined in clinical studies. Current data
on all these competitors presented at ASCO
2013 will be discussed.
Will conflicting data for Avastin in
glioblastoma bring on brain fog among
physicians?
Avastin is conditionally approved in the U.S.
(but not in Europe) for second-line
glioblastoma. The results of the AVAglio and
RTOG 0825 may have halted the opportunity
for this agent to be moved to frontline use;
however, what might happen to its current
approval?
Can second-generation ALK inhibitors
outshine Xalkori?
Xalkori® (crizotinib, Pfizer) is the first agent to
be approved for ALK+ NSCLC, as it shows
remarkable efficacy in these patients.
Unfortunately, these patients still relapse, and
second-generation ALK inhibitors are being
developed to treat these patients. Phase I data
from several of these agents which was
presented at ASCO 2013 will be compared and
discussed.
Significant Improvement in outcomes for
chronic lymphocytic leukemia: The first of
many?
The Stage I results of the CLL11 trial should
support the approval of anti-CD20 molecule
obinutuzumab (Genentech/Roche) for newlydiagnosed patients unable to receive standard
chemotherapy. Although the Stage II results
will provide a direct comparison between
obinutuzumab and Rituxan® (MabThera® in
Europe, rituximab, Genentech/Roche), data
from the Stage I favor obinutuzumab.
Kantar Health
Dr. Stephanie Hawthorne, Director
Stephanie.Hawthorne@kantarhealth.com
Bill Bagwell, General Manager
Bill.Bagwell@kantarhealth.com