Adding VCN-01 extends survival in metastatic pancreatic cancer trial
Patients treated with VCN-01 also had longer time without disease progression
Theriva Biologics’ experimental treatment VCN-01 safely increased survival when used in addition to chemotherapy for people with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer, in a Phase 2b trial.
Compared with participants in the VIRAGE trial (NCT05673811) who received chemotherapy alone, those treated with VCN-01 also experienced a longer time without disease progression.
“The exciting topline data from the VIRAGE Phase 2b trial demonstrate the potential opportunity for VCN-01 to benefit metastatic PDAC patients treated with gemcitabine/nab-paclitaxel [standard-of-care] chemotherapy,” Steven A. Shallcross, CEO of Theriva, said in a company press release.
Based on these results, the company hopes to design a Phase 3 trial to support the medication’s development. The U.S. Food and Drug Administration (FDA) has granted VCN-01 orphan drug and fast track designations to facilitate its development.
“These data, combined with recent advice from the U.S. FDA and the European Medical Agency, are expected to facilitate engagement with industry partners and enable the design of a Phase 3 confirmatory trial that, if successful, may deliver an important new therapeutic option for patients suffering this rapidly fatal disease,” Shallcross said.
PDAC is most common pancreatic cancer
PDAC accounts for more than 90% of pancreatic cancer cases. It begins growing in the ducts of the pancreas, which carry digestive juices, and commonly spreads to the liver and the peritoneum, a membrane surrounding the abdominal organs.
Although surgery is the preferred option for treating pancreatic cancers, it is not always possible, particularly when diagnosis is made at advanced stages. Combining the chemotherapies gemcitabine and nab-paclitaxel is standard of care.
In the VIRAGE trial, participants received chemotherapy alone or chemotherapy plus VCN-01. The experimental therapy is an oncolytic virus, which means it targets and replicates within tumor cells while limiting damage to healthy cells. It also enhances the access of co-administered chemotherapies and boosts the immune system’s response against the tumor.
All participants received chemotherapy in 28-day cycles until they experienced disease progression. In the VCN-01 arm of the trial, participants also received intravenous (into-the-vein) infusions of the medication before starting the first and, if applicable, fourth cycles of chemotherapy.
Receiving VCN-01 followed by one or more doses of the chemotherapy combination increased survival to a median of 10.8 months, compared to 8.6 months in the group that did not receive VCN-01. Participants in the VCN-01 group went a median 7 months before disease progression, significantly longer than the median 4.6 months in the control group.
“The significantly reduced hazard ratios for survival parameters in the VCN-01 treatment group provide compelling evidence that VCN-01 in combination with gemcitabine/nab-paclitaxel may extend the lives of metastatic PDAC patients,” Shallcross said. A metastastic cancer is one that has spread from its site of origin to another part of the body.
These effects were more pronounced in the subgroup of VCN-01 participants who received two doses, corresponding to four or more rounds of chemotherapy.
An independent data monitoring committee recently found that VCN-01 was well tolerated alongside chemotherapy. Its safety profile was within expectations, with the most common side effects being flu-like illness, fever, vomiting, nausea, and elevated liver enzymes.
Theriva is also exploring VCN-01 as a treatment for other forms of cancer, including brain and ovarian cancers.
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