OncoGenex Pharmaceuticals has reported initial results from the phase II Rainier study evaluating apatorsen in combination with Abraxane (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).
Pancreatic cancer accounts for about 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%.
"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, M.D., 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 II clinical trials in lung, prostate and bladder cancers," said Scott Cormack, president and CEO of OncoGenex.