Phase 3 trial of pancreatic cancer therapy misses primary endpoint

A phase 3 trial designed to assess an investigational drug for first-line treatment of metastatic pancreatic cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.

Development of the agent — pegvorhyaluronidase alfa (PEGPH20, Halozyme Therapeutics) — will be discontinued.

Pegvorhyaluronidase alfa is the pegylated version of rHuPH20, Halozyme’s proprietary recombinant human hyaluronidase enzyme. rHuPH20 temporarily degrades hyaluronan, a naturally occurring glycosaminoglycan that can accumulate in the tumor microenvironment of certain solid tumors.

The HALO-301 study evaluated the addition of pegvorhyaluronidase alfa with gemcitabine and nab-paclitaxel (Abraxane, Celgene).

Researchers reported a higher overall response rate in the experimental treatment group, but there were no significant differences in duration of response, PFS or OS (11.2 months vs. 11.5 months; HR = 1) compared with gemcitabine and nab-paclitaxel alone.

“This well-designed and well-executed study did not have the outcome that we or the study participants wanted or expected,” Helen Torley, MB, ChB, MRCP, president and CEO of Halozyme, said in a company-issued press release.

“Patients in both treatment arms of the HALO-301 trial surpassed the published median overall survival rates from the pivotal registration study of Abraxane plus gemcitabine as first-line therapy for metastatic pancreas cancer, published in 2013,” Torley added. “Based on the lack of benefit over standard-of-care in this study, which performed well [compared with] published data, we will be discontinuing PEGPH20 clinical development.”

A phase 3 trial designed to assess an investigational drug for first-line treatment of metastatic pancreatic cancer failed to meet its primary endpoint of OS, according to the agent’s manufacturer.

Development of the agent — pegvorhyaluronidase alfa (PEGPH20, Halozyme Therapeutics) — will be discontinued.

Pegvorhyaluronidase alfa is the pegylated version of rHuPH20, Halozyme’s proprietary recombinant human hyaluronidase enzyme. rHuPH20 temporarily degrades hyaluronan, a naturally occurring glycosaminoglycan that can accumulate in the tumor microenvironment of certain solid tumors.

The HALO-301 study evaluated the addition of pegvorhyaluronidase alfa with gemcitabine and nab-paclitaxel (Abraxane, Celgene).

Researchers reported a higher overall response rate in the experimental treatment group, but there were no significant differences in duration of response, PFS or OS (11.2 months vs. 11.5 months; HR = 1) compared with gemcitabine and nab-paclitaxel alone.

“This well-designed and well-executed study did not have the outcome that we or the study participants wanted or expected,” Helen Torley, MB, ChB, MRCP, president and CEO of Halozyme, said in a company-issued press release.

“Patients in both treatment arms of the HALO-301 trial surpassed the published median overall survival rates from the pivotal registration study of Abraxane plus gemcitabine as first-line therapy for metastatic pancreas cancer, published in 2013,” Torley added. “Based on the lack of benefit over standard-of-care in this study, which performed well [compared with] published data, we will be discontinuing PEGPH20 clinical development.”