Ipsen Becomes First to Best Standard of Care in Metastatic PDAC
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Findings from the pivotal Phase III NAPOLI 3 trial show Ipsen’s Onivyde (irinotecan liposome injection), when used as part of the investigational NALIRIFOX regimen, boosted overall survival in metastatic pancreatic ductal adenocarcinoma (PDAC), the company announced Friday.
Zev Wainberg, M.D., professor of medicine, University of California, Los Angeles, said NAPOLI 3 marked the first time a clinical trial showed this kind of result.
“[The trial] demonstrated superior overall survival and progression-free survival for an investigational regimen when compared to standard of care treatment” in the first-line setting for metastatic pancreatic ductal adenocarcinoma, he said.
NALIRIFOX is a treatment regimen that combines 50 mg/m2 of Onivyde with 2,400 mg/m2 5-fluorouracil, 400 mg/m2 leucovorin and 60 mg/m2 oxaliplatin.
NALIRIFOX improved overall survival by 17% relative to standard of care, an effect that proved to be statistically significant.
These findings were presented in a late-breaking abstract session at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
NAPOLI 3 is a randomized and open-label trial studying 770 patients who had never received chemotherapy for metastatic PDAC. The NALIRIFOX group was treated twice per month, while those assigned to standard of care were dosed three times a month.
Aside from overall survival, the trial also looked at improvement in progression-free survival, which was 31% better with the NALIRIFOX treatment. The objective response rate was also higher in the NALIRIFOX arm.
In terms of safety, NALIRIFOX induced manageable side effects, with a safety profile consistent with its individual components. Diarrhea, nausea, hypokalemia, anemia and neutropenia were the most common grade 3 or 4 treatment-emergent adverse events.
Following promising Phase III results, Ipsen filed a supplemental New Drug Application for Onivyde in metastatic PDAC in November 2022.
The company will also submit these latest data to the FDA, said Howard Mayer, executive vice president and head, of research and development, Ipsen.
A Tough Disease to Treat
The biopharma industry has seen limited success with PDAC, with few clinical studies demonstrating efficacy in recent decades, Mayer said.
Still, there has been some progress as of late.
One example came in November, when Oncolytics reported promising performance from its candidate pelareorep, in combination with atezolizumab, gemcitabine and nab-paclitaxel, in the Phase I/II GOBLET study.
Patients treated with the investigational drug achieved a 69% objective response rate, nearly three times as high as in historical control trials.
In June 2022, BioNTech, best known for its COVID-19 mRNA vaccine, announced promising Phase I data from BNT-122, an mRNA-based therapeutic in resected PDAC. The company is advancing its candidate in partnership with Genentech.