OSE Immunotherapeutics has shared survival data behind a therapeutic vaccine’s phase 2 pancreatic cancer win as the French biotech continues to point to its “pipeline in a product” potential.
The company evaluated the “off-the-shelf” neo-epitope-based vaccine, called Tedopi, alongside chemotherapy compared to chemotherapy alone among 107 patients with advanced or metastatic pancreatic ductal adenocarcinoma with no progression after eight cycles of FOLFIRINOX induction chemotherapy.
OSE reported back in March that the study had hit its primary endpoint of overall survival, but the biotech held back the detailed data for this week’s American Society of Clinical Oncology meeting. Specifically, the 54 patients who received Tedopi and chemotherapy saw a 12-month overall survival rate of 65%, according to the biotech.
Pancreatic cancer is a notoriously tough indication to treat that has seen few advances. The median follow-up time for the Tedopi trial was 21 months, with around 35% of patients dying in the course of the study.
The company also noted an “unexpectedly long” overall survival time among patients in the chemotherapy-only cohort—of 17 months rather than the expected 10-12 months.
OSE saw two complete responses in the Tedopi arm compared to none in the chemotherapy-only group.
The study’s principal investigator Cindy Neuzillet, M.D., Ph.D., branded the results “an encouraging first step towards better understanding the contribution of Tedopi in combination therapy in advanced pancreatic cancer” but said that researchers “now need more mature data on overall survival over a longer period.”
A total of 26% patients in the Tedopi arm reported serious adverse events, of which 6% were deemed to be related to Tedopi. OSE didn’t give further information on these side effects but did point out that no new safety signals were reported.
Tedopi combines 10 neo-epitopes derived from five tumor antigens, “selected for their presence in a range of tumors, offering a multi-target 'pipeline in a product' approach for HLA-A2 positive patients to address unmet needs in oncology,” Silvia Comis, M.D., chief clinical and medical research officer at OSE, explained in the release.
“The positive results for Tedopi in pancreatic cancer are promising for this devastating disease with a poor prognosis,” Comis added.
OSE is running five clinical trials of Tedopi in various oncology indications, including a phase 3 study in non-small cell lung cancer (NSCLC). Meanwhile, phase 2 readouts in NSCLC and ovarian cancer are both expected next year.