Adding elraglusib seen to improve survival in pancreatic cancer trial
Treatment alongside standard chemotherapy shows benefits for PDAC patients
Adding the experimental therapy elraglusib to standard chemotherapy led to statistically significant improvements in survival for people with metastatic pancreatic ductal adenocarcinoma (PDAC), a form of advanced pancreatic cancer, in a Phase 2 clinical trial, new data show.
These top-line findings were announced by elraglusib’s developer Actuate Therapeutics in a company press release outlining the trial’s positive results. Actuate said that it will now be engaging with regulators in the U.S. and the European Union to discuss a strategy for potentially seeking approval of the investigational treatment.
“Based on the significant improvement in survival we have seen to date in the combination arm, we look forward to working with U.S. and EU regulators in the second half of this year to map out the path to advancing elraglusib to [applications seeking approval] and making the drug available to patients as expeditiously as possible,” said Daniel Schmitt, president and CEO of Actuate.
PDAC is the most common type of pancreatic cancer. In metastatic PDAC, the cancer has spread out of the pancreas to also affect other parts of the body. Metastatic cancer is generally harder to treat and usually has worse clinical outcomes, the company noted.
“Pancreatic cancer is one of the most aggressive and difficult-to-treat malignancies, where patients urgently need new therapeutic options,” Schmitt said, noting that “there have been no major advances in improving survival in first-line treatment of metastatic pancreatic cancer in over a decade.”
Overall survival for pancreatic cancer patients show improvement
Elraglusib is designed to block the activity of GSK-3, a protein that helps cancer cells survive and resist the effects of chemotherapy.
The new top-line data come from a Phase 2 study called Actuate-1801 Part 3B (NCT03678883). In the trial, people with metastatic PDAC were treated with a standard chemotherapy combo called GnP (gemcitabine plus nab-paclitaxel). Some patients received elraglusib in addition to GnP, while others were given GnP only.
Interim results announced last year showed that one-year survival rates were significantly higher in patients given elraglusib (43.6% vs. 22.5%). At two years in the interim data, 16.7% of patients given elraglusib were still alive, whereas none of those given GnP alone were.
Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond … in this Phase 2 trial further demonstrates elraglusib’s potential to shift the treatment paradigm in [metastatic] PDAC.
The full top-line data show that the addition of elraglusib to GnP led to statistically significant improvement in overall survival, according to Actuate. The company said that there was a “substantial improvement in median overall survival” relative to what was reported in the interim analysis last year.
Further, the company noted that elraglusib demonstrated a “favorable risk-benefit profile.”
“Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond, along with a favorable risk-benefit profile in this Phase 2 trial, further demonstrates elraglusib’s potential to shift the treatment paradigm in [metastatic] PDAC,” Schmitt said.
Actuate did not disclose details about the efficacy or safety findings seen in the top-line data. The company is planning to present full results later this month at the annual meeting of the American Society of Clinical Oncology (ASCO).
“We are incredibly excited to present the topline data at ASCO,” Schmitt said.
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