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VCN-01 pancreatic cancer trial leaves survival benefit uncertain

A randomized phase 2b trial tested VCN-01 with chemotherapy in metastatic pancreatic cancer. Median survival was longer in the virus arm, but uncertainty in the analysis of everyone randomized included no benefit. A separately defined analysis group showed more favorable results. Fever, flu-like symptoms and other adverse effects were more common with the experimental virus.

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The trial adds a virus to chemotherapy

A randomized phase 2b trial tested VCN-01 alongside chemotherapy for metastatic pancreatic cancer. The experimental virus is an adenovirus designed to attack tumors. The results of the VIRAGE trial were published on September 30.[1], [2]

Participants received gemcitabine and nab-paclitaxel, either alone or with two intravenous doses of the virus. VCN-01 is engineered to express hyaluronidase, an enzyme acting on tissue around the tumor. The intention-to-treat analysis retained everyone randomized: 53 people in the virus arm and 48 in the comparison arm.[1]

Survival estimates leave room for no benefit

Median overall survival was 10.6 months with the virus and 8.6 months with chemotherapy alone. The uncertainty interval included no benefit. A separately defined full-analysis set, with 48 people in each arm, returned median survival of 10.8 and 8.6 months. Response duration was 11.2 versus 5.4 months.[1]

Fever and other adverse effects increased

Fever, flu-like symptoms, raised liver enzymes and reduced platelet counts were more frequent with VCN-01. Serious events occurred in 22.6 per cent of the virus group. Each arm had one fatal event, neither judged treatment-related. Overall response and disease-control rates did not differ significantly between the groups.[1]

References

  1. News sourceNature MedicinePancreatic cancer trial leaves overall survival benefit uncertain↩1↩2↩3↩4
  2. News sourceTheriva BiologicsVIRAGE trial tests VCN-01 with chemotherapy in pancreatic cancer↩
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