The U.S. Food and Drug Administration has granted Fast Track Designation to nadunolimab, Cantargia's anti-IL1RAP antibody, for treating patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC) with high expression levels of IL1RAP in combination with gemcitabine and nab-paclitaxel. The designation follows compelling clinical data from the CANFOUR study demonstrating significant survival benefits in this patient population.
Clinical Data Supporting FDA Decision
The Fast Track Designation is based on robust clinical evidence from the CANFOUR Phase 2 trial, which showed remarkable outcomes in patients with high IL1RAP expression. The study demonstrated a two-year survival rate of 35%, an overall survival of 14.2 months, and an overall response rate of 48% in this patient population.
In the CANFOUR trial, IL1RAP protein expression was measured by immunohistochemistry in tumor biopsies from 49 patients. The analysis revealed that patients with high baseline IL1RAP expression experienced significantly greater treatment benefits compared to those with low expression levels. Specifically, patients with high IL1RAP expression achieved a median overall survival of 14.2 months versus 10.6 months in the low expression group (p=0.012), median progression-free survival of 7.4 months versus 5.1 months (p=0.012), and overall response rates of 48% versus 30% (p=0.205).
Addressing Critical Unmet Medical Need
The designation reflects the severe unmet medical need in metastatic pancreatic cancer, where treatment options remain severely limited. Current data shows that overall survival after first-line treatment for metastatic PDAC is typically less than 12 months, with a five-year survival probability of less than 5% for metastatic disease. The prognosis has shown minimal improvement over the past two decades, highlighting the urgent need for new therapeutic approaches.
High levels of IL1RAP, the target of nadunolimab, are associated with shorter survival in pancreatic cancer patients, making this biomarker-driven approach particularly relevant for identifying patients who may benefit most from treatment.
Fast Track Benefits and Development Path
Fast Track Designation provides several advantages that will accelerate nadunolimab's development pathway. The designation enables more frequent meetings and communication with the FDA, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and rolling review opportunities that allow completed sections of the Biologic License Application to be submitted for FDA review rather than waiting for the entire application to be completed.
"The recognition from the FDA for our clinical and translational data on nadunolimab and the future path in pancreatic cancer is an outstanding development for Cantargia," said Damian Marron, CEO of Cantargia. "The support from the FDA for the continued development of nadunolimab in the high IL1RAP subset of PDAC patients further strengthens our efforts to bring this potentially important new treatment to these patients who currently lack options."
Next Development Steps
Cantargia is currently preparing for the next stage of clinical development by developing a diagnostic test to identify patients with high IL1RAP expression for inclusion in future clinical studies. This biomarker-driven approach will be crucial for selecting the patient population most likely to benefit from nadunolimab treatment.
Nadunolimab is a fully humanized Fc-enhanced IgG1 monoclonal antibody targeting IL1RAP, designed to treat PDAC, a serious and life-threatening malignant neoplasm of the pancreas. The antibody is part of Cantargia's broader oncology program, which includes studies in combination with chemotherapy for pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer.
