FibroGen, a biopharmaceutical company, on Monday said the results from the Phase 1/2 clinical trial, testing pamrevlumab in combination with standard-of-care chemotherapy in patients with locally advanced unresectable pancreatic cancer (LAPC), bring good news.
Principal investigator Vincent J. Picozzi, Jr. Director, Pancreas Center of Excellence, Virginia Mason Cancer & Digestive Diseases Institutes said the data suggest that pamrevlumab in combination with chemotherapy has the potential to become a neoadjuvant treatment regimen for locally advanced unresectable pancreatic cancer patients that has not existed before.
FibroGen explained that tatients with locally advanced pancreatic cancer (without metastasis) tend to have a poor prognosis with a median survival of 9–18 months. In patients who have undergone resection of their tumor, median survival and five-year survival rates have been reported to be higher than those without resection. Therefore, treatment to achieve a surgical resection in this patient population is a meaningful treatment goal to potentially achieve a favorable overall survival outcome.
According to FibroGen, in this open-label, randomized Phase 1/2 study, pamrevlumab was administered in combination with standard-of-care chemotherapy and compared to treatment with chemotherapy alone in patients with locally advanced pancreatic ductal adenocarcinoma, who were not eligible for surgical resection based on histology, computerized tomography (CT) scans, and laparoscopy criteria, prior to randomization. Upon completion of the six months of study drug treatment, patients underwent surgical eligibility assessment based on pre-specified objective criteria. The study enrolled 37 patients: 24 received pamrevlumab + chemotherapy: 13 received chemotherapy alone.
Elias Kouchakji, Senior Vice President, Clinical Development and Drug Safety, said: “Patients with unresectable locally advanced pancreatic cancer are in need of an innovative and effective treatment with the potential to transform non-operable cancer into resectable disease. The updated clinical results we are reporting at ASCO suggest that pamrevlumab may improve the treatment outcomes for patients who are currently deemed unresectable.”