Welcome to Partners in Pancreatic Cancer. I am Dr. Ramesh Ramanathan from the Mayo Clinic in Phoenix, Arizona. I am frequently asked, “What are some of the most promising clinical trials we should be keeping an eye on in the front-line and second-line therapy for advanced pancreatic cancer?”
There are a number of promising agents in clinical trials. One of the studies that I am involved with is pegylated PH20 with the pegylated hyaluronidase. This is in a phase 3 registration study sponsored by Halozyme in combination with gemcitabine and nab-paclitaxel. An interesting aspect of this study is that it is only for hyaluronan-high tumors. We expect about 40% of front-line patients will have high hyaluronan levels by immunohistochemistry, and these patients are randomized to gemcitabine-nab-paclitaxel with or without PEGPH20.
Another clinical trial is a SWOG study with FOLFIRINOX in combination with PEGPH20 which was closed at interim analysis. This was in unselected patients where PEGPH20 did not show a benefit. This is something to keep an eye on.
Another agent which is nearing completion of a phase 3 study is ibrutinib. This is also in front-line with gemcitabine and nab paclitaxel, and hopefully, we will be seeing the results of this study in 2018 or 2019.
Another agent is a stem cell factor called BBI-608. This is in front-line studies with gemcitabine and nab-paclitaxel and also a second-line study with 5-FU and MM-398. Everyone is very interested in immuno-oncology studies and there are a number of studies, probably 30 to 40 studies. These are still phase 1 and phase 2 in the first-, second-line and refractory settings with a number of immuno oncology agents and co-stimulatory molecules. These would be very interesting as proof of concept. If these are active, we will see these moving to randomized studies. Thank you for viewing this activity.