Halozyme Therapeutics reports positive top-line results from HALO 202 study of PEGPH20


US-based biotechnology company Halozyme Therapeutics has reported positive topline results from a combined analysis of two stages of its Phase II HALO 202 study of PEGPH20 in combination with abraxane and gemcitabine to treat pancreatic cancer.

PEGPH20 is a PEGylated form of the proprietary recombinant human hyaluronidase developed as a potential systemic treatment of tumours that accumulate hyaluronan.

It temporarily degrades HA, which is a dense component of the tumour microenvironment that can accumulate in higher concentrations around certain cancer cells leading to constriction of blood vessels and inhibit therapeutic intervention.

The Phase II HALO 202 multi-centre, randomised clinical trial is evaluating efficacy of PEGPH20 in treating patients with metastatic pancreatic cancer.

The study was primarily focused on determining improvement in progression-free survival (PFS) in patients administered with PEGPH20 in combination with gemcitabine and abraxane when compared with gemcitabine and abraxane alone.

The second primary endpoint of the study was to evaluate the thromboembolic event rate experienced by patients treated with PEGPH20.

"The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer."

Secondary endpoints of the trial were to determine objective response rate and overall survival.

Results suggested that patients with high levels of hyaluronan (HA-High) treated with PEGPH20 combined with gemcitabine and abraxane experienced improved PFS.

Stage 2 of the study exhibited 91% improvement in median PFS for HA-High patients treated with PEGPH20, along with achieving reduction in the rate of thromboembolic events in the PEGPH20 arm.

University of Washington School of Medicine professor Fred Hutchinson Cancer Research Center pancreatic cancer expert and trial lead investigator Dr Sunil Hingorani said: "The Study 202 data confirms for the first time in a randomised Phase II trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment.

“The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer.

"The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase III study."

In the US, pancreatic cancer is the third-leading cause of cancer related death, with more than 65,000 people in the country and top five European countries are diagnosed annually with advanced cases of the disease.