Early results ‘extremely positive’ for pancreatic cancer treatment combo
64% of patients on Ampligen, Imfinzi lived longer than 6 months: Interim data
A clinical trial has revealed encouraging results for people with metastatic pancreatic cancer who received Ampligen (rintatolimod) alongside Imfinzi (durvalumab). Nearly two-thirds of patients in the study who had stable disease after chemotherapy lived longer than six months.
This outcome surpasses expectations for patients with metastatic pancreatic cancer, according to Aim Immunotech, the company behind Ampligen.
“Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches,” Thomas K. Equels, CEO of Aim, said in a company press release.
Ampligen and Imfinzi both work to trigger the immune system to attack and destroy cancer cells. Ampligen works to activate certain signaling molecules that prompt immune cells to go on the offensive, while Imfinzi is a checkpoint inhibitor, which is a therapy that blocks molecules cancer cells use to help escape the immune system.
Ampligen is an experimental therapy that’s not approved for any indication. Imfinzi is approved in the U.S. for several types of cancer, though it is not specifically authorized for pancreatic cancer.
DURIPANC testing Ampligen plus Imfinzi in up to 43 patients
A Phase 2 clinical trial called DURIPANC (NCT05927142) is testing Ampligen plus Imfinzi in up to 43 people with pancreatic cancer that is metastatic (has spread to other parts of the body) and is stable after a chemotherapy regimen called FOLFIRINOX. The study is sponsored by Erasmus Medical Center in the Netherlands. It’s being conducted in collaboration with Aim and AstraZeneca, which markets Imfinzi. Enrollment is ongoing at Erasmus.
To date, 14 people have been enrolled in the study, and interim data have shown the combination of Ampligen and Imfinzi had a generally good safety profile, with Aim reporting no significant toxicity.
Additionally, 64% of patients had overall survival times longer than six months, and three patients (21%) were alive without disease progression after six months.
“Our preliminary data suggests that the combination of [Ampligen and Imfinzi] is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting,” said Casper van Eijck, MD, PhD, of Erasmus Medical Center. “Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes.”
Beyond safety and clinical benefit, DURIPANC is evaluating how the combination treatment affects markers of immune function. Equels is hopeful that findings from the trial “will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need.”
About the Author
