Rintatolimod Plus Durvalumab Holds Post-Chemo Promise in Metastatic PDAC

Rintatolimod (Ampligen) combined with durvalumab (Imfinzi) has continued to exhibit encouraging efficacy, safety, and favorable quality of life in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) post-chemotherapy, according to interim phase 2 data from the DURIPANC study (NCT05927142).^1,2

As of the latest data cut-off on December 1, 2025, encouraging trends in progression-free survival (PFS) and overall survival (OS) have been observed in the 18 patients treated with the combination to date, along with a positive safety profile and consistent patient reports of high quality of life. According to investigators at Erasmus University Medical Center, more detailed data are expected to be published later in 2026.

In preliminary data from July 2025, approximately 21% of 14 patients had achieved PFS exceeding 6 months, and 64% had achieved OS greater than 6 months, suggesting a potentially clinically meaningful benefit in this pretreated population.

Further, initial immune profiling shows evidence of coordinated activation of both innate and adaptive immune responses, consistent with the proposed mechanism of action of the combination.

“Erasmus [Medical Center] clinicians and researchers are seeing immune system changes that suggest a coordinated activation of innate and adaptive responses—or, to put it more simply, the combination of [rintatolimod] and durvalumab seems to be enhancing the body’s natural immune system,” said Casper van Eijck, MD, PhD, professor at Erasmus University Medical Center, in a news release.¹ “This perceived mechanism of action together with the clinical results supports continued investigation of this combination in post-FOLFIRINOX patients with [PDAC].”

Rintatolimod is an investigational double-stranded RNA agent and highly selective TLR3 agonist with immune-modulating activity. By stimulating the innate immune system, rintatolimod is hypothesized to increase dendritic cell maturation and the cross-priming of cytotoxic CD8-positive T cells. When used in conjunction with the anti–PD-L1 immune checkpoint inhibitor durvalumab, the combination aims to overcome the immunosuppressive "cold" tumor microenvironment characteristic of pancreatic cancer.

Rintatolimod is in clinical development across multiple other pancreatic cancer indications as well as in breast cancer and melanoma. It holds orphan drug designations in pancreatic cancer from the FDA and European Medicines Agency (EMA).¹

About the DURIPANC Study

The single-center, open-label DURIPANC study is a phase 1/2 safety and efficacy evaluation of rintatolimod plus durvalumab in patients with metastatic PDAC who have radiologically confirmed stable disease following 8 cycles of standard FOLFIRINOX chemotherapy.³

The study builds upon a prior early access program in which rintatolimod was administered as monotherapy to 57 patients with late-stage pancreatic cancer. Here, rintatolimod was associated with a median survival of 19.7 months, more than double the OS seen with the historical standard of care (8.6 months).¹

The phase 1 safety run-in portion of the study has been completed, in which the combination demonstrated a manageable safety profile and was well tolerated by patients.² In the ongoing phase 2 portion, the primary end point is clinical benefit rate, while secondary end points include OS, PFS, quality of life, and immune response. Patients are receiving 1500-mg doses of durvalumab via intravenous (IV) infusion on every first day of a 28-day cycle for up to 12 cycles along with 200 to 400 mg of IV rintatolimod twice weekly for up to 6 weeks.

With 18 patients enrolled as of the recent readout, the phase 2 study is continuing recruitment for a total of 25 patients at Erasmus University Medical Center.

REFERENCES

1. AIM ImmunoTech reports positive year-end interim clinical progress from phase 2 study evaluating Ampligen® (rintatolimod) in combination with AstraZeneca’s Imfinzi® (durvalumab) for the treatment of pancreatic cancer. News release. AIM ImmunoTech. February 5, 2026. Accessed February 9, 2026. https://tinyurl.com/cukyv3hm

2. DURIPANC, year-end clinical progress update. AIM ImmunoTech. Updated 2025. Accessed February 9, 2026. https://tinyurl.com/4ysdz369

3. Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy efficacy (DURIPANC). ClinicalTrials.gov. Updated February 25, 2025. Accessed February 9, 2026. https://clinicaltrials.gov/study/NCT05927142