Shire analysis reveals encouraging Onivyde insights

Shire presented the results of a widespread review of metastatic pancreatic cancer across nine countries and said there was a benefit witnessed for those undergoing a combined treatment with Onivyde, a drug for which it holds a licence outside of the US.

Presenting the results of a review of more than 2,500 patient records with metastatic adenocarcinoma of the pancreas, the FTSE 100 pharma group said enhanced recognition of symptoms and a standardised treatment approach may help improve diagnosis, patient care and outcomes for a cancer with poor prognosis and low survival rate.

The new analysis highlighted additional insights into use of liposomal irinotecan, known as nal-IRI and branded Onivyde, in combination with chemotherapy combination 5-fluorouracil (5-FU) with leucovorin (LV) in patients with metastatic pancreatic adenocarcinoma who have disease progression on gemcitabine-based treatment.

Napoli-1 is the first global, randomized open-label Phase 3 trial to show extended overall survival in metastatic pancreatic adenocarcinoma after gemcitabine-based therapy through treatment with Onivyde combined with 5-FU and LV. Patients were enrolled at 76 sites in 14 countries across North America, Europe, Asia, South America and Australia.

"While first-line treatments are approved for patients with pancreatic adenocarcinoma, disease progression after initial therapy is inevitable and patients with this disease have a poor prognosis and low survival rate," said Teresa Macarulla Mercadé, a clinical investigator in the gastrointestinal tumour program at the Vall d'Hebrón Institute of Oncology in Barcelona.

"To further our understanding of the use of nal-IRI in the treatment of mPDAC, we conducted four separate Napoli-1 subgroup analyses investigating the effect of selected baseline parameters. These analyses demonstrated that a consistent treatment benefit was observed in patients treated with nal-IRI in combination with 5-FU/LV across the subgroups tested."

Floris de Jong, Shire's global medical franchise lead for solid tumors, said pancreatic adenocarcinoma is typically diagnosed late in the course of the disease, when outcomes are generally poor.

"These analyses from patient records and Napoli-1 collectively provide important new insights for the diagnosis and treatment of patients with this difficult-to-treat cancer. Specifically, the results of the retrospective review indicate that enhanced awareness of, and attention to symptoms both by health care providers and the public at large may help improve mPAC diagnosis, care and outcomes."