OncoGenex Pharmaceuticals, Inc. OGXI announced today initial
results from the Phase 2 Rainier(TM) study evaluating apatorsen in
combination with ABRAXANE(R) (paclitaxel protein-bound particles for
injectable suspension) (albumin-bound) and gemcitabine compared to ABRAXANE
and gemcitabine alone in patients with untreated metastatic pancreatic
cancer. The addition of apatorsen to ABRAXANE and gemcitabine did not
demonstrate a survival benefit compared to ABRAXANE and gemcitabine alone.
The study was sponsored and conducted by Sarah Cannon Research Institute
(SCRI) and further results will be presented by SCRI at a future medical
meeting.
Pancreatic cancer accounts for approximately 338,000 new cases each year
worldwide. In the U.S., it continues to be the fourth leading cause of
cancer death. Most pancreatic cancer patients will die within the first year
of diagnosis, and five-year survival rates are less than 10 percent.
"Over the last decade, very few treatments have been able to demonstrate a
survival benefit in this very difficult-to-treat cancer," said Johanna
Bendell, MD, Director of the GI Cancer Research Program, SCRI, and a primary
investigator on the trial. "We understand the dire need for new treatment
options and are thankful to the patients who participated in this trial."
The most common grade 3/4 treatment-related toxicities on the apatorsen arm
were anemia, neutropenia and fatigue, also consistent with the chemotherapy
regimen side effects. These and other adverse events (AEs) observed on the
apatorsen arm were similar to those seen in previous trials, with the
exception of an increase in grade 4 or greater AEs and serious AEs in this
pancreatic cancer trial. While patients in the apatorsen arm had fewer
treatment discontinuations due to progressive disease, more patients
discontinued therapy due to AEs.
"While we are disappointed with the Rainier results, we also recognize the
challenges associated with developing effective treatments for such a lethal
and complex disease. We remain confident in our broader apatorsen program,
which includes ongoing Phase 2 clinical trials in lung, prostate and bladder
cancers," said Scott Cormack, President and CEO of OncoGenex.
Recent Apatorsen Data
Results from an exploratory analysis of the Phase 2 Borealis-1(TM) trial
showed that patients with metastatic bladder cancer with poor prognostic
features experienced a reduction in risk of death with the addition of 600
mg apatorsen added to first-line chemotherapy, compared to chemotherapy
alone.
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