Extremely important, not just exciting, were the results of Halozyme Therapeutics’s (HALO) Phase 2 randomized, multi-center clinical trial of its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer.
The results demonstrated a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone.
Stage 2 of the study demonstrated a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm. The study achieved its primary endpoint in demonstrating a reduction in the rate of thromboembolic events, which usually occur to patients with pancreatic cancer.
Why these results are to appreciate and cheer, not to doubt.
PEGPH20 is a PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase enzyme that temporarily degrades hyaluronan (HA).
What does PEGPH20 degradation of hyaluronan have to do with treating cancer?
Hyaluronan — a kind of polysaccharide is recognized to form a dense component of the cancer microenvironment. It is postulated that the accumulation of higher concentrations of hyaluronan around certain cancers would constrict the blood vessels, making it hard for cancer treatments to reach cancer cells. By degrading Hyaluronan, PEGPH20 is expected to relax the constricted blood vessels, thus, permits the standard of care treatments to reach and kill cancer cells.
Pancreatic cancer tops the list of cancers that accumulate high levels of hyaluronan (HA-High) in their microenvironment that contributes to the failure standard of care treatments.
We believe that the results of the clinical studies confirmed that PEGPH20 has succeeded in accomplishing its task of degrading hyaluronan, which consequently confirm that high hyaluronan presence around the pancreatic cancer impedes standard of care treatments.
The Importance of Reducing Thromboembolic events
The results from the stage 2 of the Phase 2 trial have also demonstrated statistically significant reduction in the rate of thromboembolic events in the PEGPH20 arm vs. the control arm.
These results are remarkable and extremely important. Cancer is recognized by scientists and oncologists as one of the most important acquired—but often overlooked—risk factor for the development of thromboembolic events. As a result, people with cancers can develop heart attacks, stokes and pulmonary embolisms, which are life threatening and might result of the patients’ death. These events motivated researchers around the world to spend enormous amount of time and effort in order to pinpoint the causes for these life-threatening events.
Many findings have come out as a result of the scientists’ research efforts. Among these is a finding suggesting that tumor masses compromise venous blood flow by extrinsic compression of adjacent low-flow vessels.
Thanks to PEGPH20 trial results, we know now that high levels of hyaluronan in the cancer microenvironment is behind thromboembolic events.
It is well-recognized that pancreatic cancer is among cancers that cause high percentage of thromboembolic events. The success of Halozyme’s drug in reducing the rate of these life-threatening events should be cheered by researchers, oncologists and cancer patients. The news should surely be also cheered by the FDA, which granted orphan drug designation to PEGPH20 for the treatment of pancreas cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer.
We appreciated the clinical trial results of PEGPH20 in pancreatic cancer and congratulate Halozyme scientists for a job well done.
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